Primary DysmenorrheaEarly Phase 1EPAPDNCT04245540

Effects of Pau d' Arco in Primary Dysmenorrhea

A Early Phase 1 study testing Pau d' Arco in people with Primary Dysmenorrhea, run by National University of Natural Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: Primary Dysmenorrhea
What is being tested?: Pau d' Arco
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: 30 Jul 2019to 15 Dec 2022
Phase: Early Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Biologically female
Ages 18-45
Presence of primary dysmenorrhea
Has a 'smart' phone and is willing to download and use an electronic application for use during the study.
Willing to take a non-hormonal form of birth control throughout the trial period (abstinence, condom, diaphragm, or copper IUD (ParaGard))
Lives in the Portland area

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Able to speak, read and write English
Has reliable transportation to clinic
Willing to have four fasting blood draws taken
Wiling to collect menstrual fluid in a Diva© cup on the first day of menstruation and ability to deliver it to the clinic on the same day
Ability to receive and complete electronic VAS scales
Pain scale rating of 6 or higher on the VAS scale
Monthly pain that correlates with menstruation

Who cannot join

Presence of secondary dysmenorrhea
General health measures outside of normal range:
Blood pressure readings obtained at the Screening Visit reveal hypotension (≤90/60 mmHg) or hypertension (≥140/90 mmHg).
Aspartate aminotransferase (AST) < 8 U/L or > 48 U/L at the Screening Visit.
Alanine aminotransferase (AST) < 7 U/L or > 55 U/L at the Screening Visit.
Estimated glomerular filtration rate (eGFR) < 90 ml/min/1.73m2 at the Screening Visit.

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An INR value > 1.1 at the Screening Visit.
A red blood cell count < 3.90 million cells/mcL or > 5.03 million cells/mcL.
A hemoglobin value of < 12 g/dL (120 g/L) or > 15.5 g/dL (155 g/L).
A hematocrit value of < 34.9% or > 44.5%.
A white blood cell count < 3.5 billion cells/L (3,500 cells/mcL) or > 10.5 billion cells/L (10,500 cells/mcL)
A platelet count < 150 billion/L (150,000/mcL) or > 450 billion/L (450,000 mcL).
Women who are nursing, pregnant, or planning pregnancy in the next four months
Difficulty swallowing or aversion to capsules, tablets, or pills
Currently taking, and unwilling to discontinue, NSAIDs (Aspirin, Ibuprofen)
Currently taking dietary supplements with any of the following ingredients in amounts over 250 mg/day: cinnamon, garlic, ginger, turmeric, and/or curcumin
Consumption of >1 alcoholic drink per day, during the study period
Currently taking any anticoagulation medications (Warfarin/Coumadin)
Currently taking, or have taken in the past two months, hormonal forms of birth control
Unwillingness, or inability, to take a monthly pregnancy test during the timeline of the study (3 pregnancy tests)
Past or present medical history of any of the following:
Blood clotting disorders (von Willebrand disease, Hemophilia A, Hemophilia B, etc.)
Liver disease (cirrhosis, hepatitis, liver failure, jaundice, liver cancer, etc.)
Kidney disease (chronic kidney disease, polycystic kidney disease, etc.)
Cardiac disease (hypertension, heart failure, cardiomyopathy, etc.)
Anemia (iron deficiency, sickle cell, aplastic, etc.)
Inflammatory bowel disease
Irritable bowel syndrome
Endometriosis
Obstructive endometrial polyps
Chronic pelvic inflammatory disease
Polycystic Ovarian Syndrome
Adenomyosis
Intrauterine or pelvic adhesions
Congenital obstructive mullerian malformations
Cervical stenosis
Use of an intrauterine contraceptive device that causes pain
Pelvic congestion syndrome
Reproductive cancer (uterine cancer, ovarian cancer, endometrial cancer, etc.)
Ovarian cysts
Fibroids
Uteropelvic junction obstruction

Trial locations and contacts

1 site in 1 country.

United States1 site

National University of Natural Medicine
Portland, Oregon, 97201

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About this study

Official title: A Single Arm, Open-label Pilot Trial Examining the Effects of Pau d' Arco on Primary Dysmenorrhea in Reproductive Age Women

A single arm, open-label trial evaluating safety and tolerability of encapsulated Tabebuia avellanedae in 12 generally healthy women aged 18-45 with primary dysmenorrhea (PDM). This will be the first study evaluating the safety and tolerability of Tabebuia avellanedae in PDM. We also aim to collect proof-of-concept mechanistic data supporting the hypothesis that Tabebuia avellanedae reduces PGE2 concentration in vivo in women with PDM.

Read the detailed description

This is a single arm, open-label trial evaluating safety and tolerability of 1,050 mg/day of encapsulated Tabebuia avellanedae every day for 2 months, as well as effects of the treatment on quality of life, pain intensity, and pain interference, in 12 generally healthy women aged 18-45 with PDM. Outcomes of this study include questionnaires to evaluate: safety and tolerability using standardized adverse events scales (primary); participant reported measurements of quality of life, pain intensity, and pain interference around menses collected on validated instruments (secondary); and blood concentration of PGE2 and high-sensitivity C-reactive protein (tertiary). The protocol followed the SPIRIT guidelines and fulfilled the SPIRIT checklist.

Conditions: Primary Dysmenorrhea
Being tested: Pau d' Arco
Keywords: primary dysmenorrhea, dysmenorrhea, tabebuia avellanedae, tabebuia impetiginosa, pau d' arco, taheebo bark, menstrual pain, pelvic pain, menstrual cramps, painful menstruation, menstrual distress, herbal medicine, phytomedicine, complementary therapy, complementary medicine, alternative therapy, alternative medicine, traditional medicine, plant extracts, supplement
Medical subject headings: Dysmenorrhea, Pelvic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pau d' ArcoDietary supplement
Encapsulated herbal Pau d' Arco.

Study groups in NCT04245540
Study group	Role	What they receive
Active	Experimental	1,050 mg per day of encapsulated Pau d' Arco taken orally for 2 months. Receives: Dietary Supplement: Pau d' Arco

What is being measured

The primary outcome is the main question the study is designed to answer.

Red Blood Cell Count
Red blood cell count will be collected through a Complete Blood Count (CBC) test. Normal ranges for this test are 3.80-5.10 Million/uL. Red blood cell (RBC) count of less than 3.80 Million/uL will be considered as new onset anemia and will result in the participant being withdrawn from the study. This measure will be reported as: "Number of participants with normal RBC count levels," "Number of participants with abnormal RBC count values," and "Number of participants withdrawn from the study based on decreased RBC count values."
Measured: Mean change in Screening RBC count to 4 weeks.
Red Blood Cell Count
Red blood cell count will be collected through a Complete Blood Count (CBC) test. Normal ranges for this test are 3.80-5.10 Million/uL. Red blood cell (RBC) count of less than 3.80 Million/uL will be considered as new onset anemia and will result in the participant being withdrawn from the study. This measure will be reported as: "Number of participants with normal RBC count levels," "Number of participants with abnormal RBC count values," and "Number of participants withdrawn from the study based on decreased RBC count values."
Measured: Mean change in Screening RBC count to 8 weeks.
Red Blood Cell Count
Red blood cell count will be collected through a Complete Blood Count (CBC) test. Normal ranges for this test are 3.80-5.10 Million/uL. Red blood cell (RBC) count of less than 3.80 Million/uL will be considered as new onset anemia and will result in the participant being withdrawn from the study. This measure will be reported as: "Number of participants with normal RBC count levels," "Number of participants with abnormal RBC count values," and "Number of participants withdrawn from the study based on decreased RBC count values."
Measured: Mean change in 4 weeks RBC count to 8 weeks.
Hemoglobin
Hemoglobin is a protein in red blood cells that carries oxygen throughout the body. Hemoglobin will be collected through a Complete Blood Count (CBC) test. Normal ranges for this test are 11.7-15.5 grams per deciliter (g/dL). Hemoglobin of less than 11.7 g/dL or greater than 15.5 g/dL will be considered as abnormal. This measure will be reported as: "Number of participants with normal Hemoglobin levels" and "Number of participants with abnormal Hemoglobin values."
Measured: Mean change in Screening Hemoglobin g/dL to 4 weeks.
Hemoglobin
Hemoglobin is a protein in red blood cells that carries oxygen throughout the body. Hemoglobin will be collected through a Complete Blood Count (CBC) test. Normal ranges for this test are 11.7-15.5 grams per deciliter (g/dL). Hemoglobin of less than 11.7 g/dL or greater than 15.5 g/dL will be considered as abnormal. This measure will be reported as: "Number of participants with normal Hemoglobin levels" and "Number of participants with abnormal Hemoglobin values."
Measured: Mean change in Screening Hemoglobin g/dL to 8 weeks.
Hemoglobin
Hemoglobin is a protein in red blood cells that carries oxygen throughout the body. Hemoglobin will be collected through a Complete Blood Count (CBC) test. Normal ranges for this test are 11.7-15.5 grams per deciliter (g/dL. Hemoglobin of less than 11.7 g/dL or greater than 15.5 g/dL will be considered as abnormal. This measure will be reported as: "Number of participants with normal Hemoglobin levels" and "Number of participants with abnormal Hemoglobin values."
Measured: Mean change in 4 weeks Hemoglobin g/dL to 8 weeks.
Hematocrit
Hematocrit is the ratio of the volume of red blood cells to the total volume of blood. Hematocrit will be collected through a Complete Blood Count (CBC) test. Normal ranges for this test are 35.0-45.0 %. Hemoglobin of less than 35.0% or greater than 45.0% will be considered as abnormal. This measure will be reported as: "Number of participants with normal Hemotocrit % levels" and "Number of participants with abnormal Hematocrit % values."
Measured: Mean change in Screening Hematocrit % to 4 weeks.
Hematocrit
Hematocrit is the ratio of the volume of red blood cells to the total volume of blood. Hematocrit will be collected through a Complete Blood Count (CBC) test. Normal ranges for this test are 35.0-45.0 %. Hemoglobin of less than 35.0% or greater than 45.0% will be considered as abnormal. This measure will be reported as: "Number of participants with normal Hemotocrit % levels" and "Number of participants with abnormal Hematocrit % values."
Measured: Mean change in Screening Hematocrit % to 8 weeks.
Hematocrit
Hematocrit is the ratio of the volume of red blood cells to the total volume of blood. Hematocrit will be collected through a Complete Blood Count (CBC) test. Normal ranges for this test are 35.0-45.0 %. Hemoglobin of less than 35.0% or greater than 45.0% will be considered as abnormal. This measure will be reported as: "Number of participants with normal Hemotocrit % levels" and "Number of participants with abnormal Hematocrit % values."
Measured: Mean change in 4 weeks Hematocrit % to 8 weeks.
Mean Corpuscular Volume
Mean Corpuscular Volume (MCV) measures the average red blood cell volume. MCV will be collected through a Complete Blood Count (CBC) test. Normal ranges for this test are 80.0-100.0 femtolitre (fL). MCV of less than 80.0 fL or greater than 100.0 fL will be considered as abnormal. This measure will be reported as: "Number of participants with normal MCV fL levels" and "Number of participants with abnormal MCV fL values."
Measured: Mean change in Screening MCV fL to 4 weeks.
Mean Corpuscular Volume
Mean Corpuscular Volume (MCV) measures the average red blood cell volume. MCV will be collected through a Complete Blood Count (CBC) test. Normal ranges for this test are 80.0-100.0 femtolitre (fL). MCV of less than 80.0 fL or greater than 100.0 fL will be considered as abnormal. This measure will be reported as: "Number of participants with normal MCV fL levels" and "Number of participants with abnormal MCV fL values."
Measured: Mean change in Screening MCV fL to 8 weeks.
Mean Corpuscular Volume
Mean Corpuscular Volume (MCV) measures the average red blood cell volume. MCV will be collected through a Complete Blood Count (CBC) test. Normal ranges for this test are 80.0-100.0 femtolitre (fL). MCV of less than 80.0 fL or greater than 100.0 fL will be considered as abnormal. This measure will be reported as: "Number of participants with normal MCV fL levels" and "Number of participants with abnormal MCV fL values."
Measured: Mean change in 4 weeks MCV fL to 8 weeks.
Mean Corpuscular Hemoglobin
Mean Corpuscular Hemoglobin (MCH) measures the average mass of hemoglobin per red blood cell. MCH will be collected through a Complete Blood Count (CBC) test. Normal ranges for this test are 27.0-33.0 picogram (pg). MCH of less than 27.0 pg or greater than 33.0 pg will be considered as abnormal. This measure will be reported as: "Number of participants with normal MCH pg levels" and "Number of participants with abnormal MCH pg values."
Measured: Mean change in Screening MCH pg to 4 weeks.
Mean Corpuscular Hemoglobin
Mean Corpuscular Hemoglobin (MCH) measures the average mass of hemoglobin per red blood cell. MCH will be collected through a Complete Blood Count (CBC) test. Normal ranges for this test are 27.0-33.0 picogram (pg). MCH of less than 27.0 pg or greater than 33.0 pg will be considered as abnormal. This measure will be reported as: "Number of participants with normal MCH pg levels" and "Number of participants with abnormal MCH pg values."
Measured: Mean change in Screening MCH pg to 8 weeks.
Mean Corpuscular Hemoglobin
Mean Corpuscular Hemoglobin (MCH) measures the average mass of hemoglobin per red blood cell. MCH will be collected through a Complete Blood Count (CBC) test. Normal ranges for this test are 27.0-33.0 picogram (pg). MCH of less than 27.0 pg or greater than 33.0 pg will be considered as abnormal. This measure will be reported as: "Number of participants with normal MCH pg levels" and "Number of participants with abnormal MCH pg values."
Measured: Mean change in 4 weeks MCH pg to 8 weeks.
Mean Corpuscular Hemoglobin Concentration
Mean Corpuscular Hemoglobin Concentration (MCHC) measures the average mass of hemoglobin per red blood cell. MCH will be collected through a Complete Blood Count (CBC) test. Normal ranges for this test are 27.0-33.0 picogram (pg). MCH of less than 27.0 pg or greater than 33.0 pg will be considered as abnormal. This measure will be reported as: "Number of participants with normal MCH pg levels" and "Number of participants with abnormal MCH pg values."
Measured: Mean change in 4 weeks MCH pg to 8 weeks.
Recruitment and retention.
Recruitment of 12 women with primary dysmenorrhea and retention of at least 10 participants throughout the course of the study. Reported as number of recruited participants, number of excluded participants, and number of drop out participants.
Measured: Percent change from Baseline Recruitment to 8 weeks.
Incidence of Intervention-attributable Adverse Events
Self-reported adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events. Reported as: New onset "FDA serious" adverse events; New onset "moderate" adverse events; all reported adverse events
Measured: Percent change from Baseline Intervention-attributable Adverse Events to 4 weeks.
Incidence of Intervention-attributable Adverse Events
Self-reported adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events. Reported as: New onset "FDA serious" adverse events; New onset "moderate" adverse events; all reported adverse events
Measured: Percent change from Baseline Intervention-attributable Adverse Events to 8 weeks.
Incidence of Intervention-attributable Adverse Events
Self-reported adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events. Reported as: New onset "FDA serious" adverse events; New onset "moderate" adverse events; all reported adverse events
Measured: Percent from 4 weeks Intervention-attributable Adverse Events to 8 weeks.
Aspartate aminotransferase (AST)
Aspartate aminotransferase is an enzyme that is often measured in blood as an indication of liver toxicity. This value is reported as cubic rack units (U) per liter (L); (U/L). Normal ranges are 10-30 U/L. Any participant with a value of 2 times or higher of the upper end of this range (60 U/L or greater) will be withdrawn from the study per study stopping criteria. This value will be reported as: "Number of participants with normal AST levels," "Number of participants with abnormal AST values," and "Number of participants withdrawn from the study based on elevated AST values."
Measured: Mean change in Screening AST values at 4 weeks.
Aspartate aminotransferase (AST)
Aspartate aminotransferase is an enzyme that is often measured in blood as an indication of liver toxicity. This value is reported as cubic rack units (U) per liter (L); (U/L). Normal ranges are 10-30 U/L. Any participant with a value of 2 times or higher of the upper end of this range (60 U/L or greater) will be withdrawn from the study per study stopping criteria. This value will be reported as: "Number of participants with normal AST levels," "Number of participants with abnormal AST values," and "Number of participants withdrawn from the study based on elevated AST values."
Measured: Mean change in Screening AST values at 8 weeks.
Aspartate aminotransferase (AST)
Aspartate aminotransferase is an enzyme that is often measured in blood as an indication of liver toxicity. This value is reported as cubic rack units (U) per liter (L); (U/L). Normal ranges are 10-30 U/L. Any participant with a value of 2 times or higher of the upper end of this range (60 U/L or greater) will be withdrawn from the study per study stopping criteria. This value will be reported as: "Number of participants with normal AST levels," "Number of participants with abnormal AST values," and "Number of participants withdrawn from the study based on elevated AST values."
Measured: Mean change in 4 weeks AST values at 8 weeks.
Alanine aminotransferase (ALT)
Alanine aminotransferase is an enzyme that is often measured in blood as an indication of liver toxicity. This value is reported as cubic rack units (U) per liter (L); (U/L). Normal ranges are 6-29 U/L. Any participant with a value of 2 times or higher of the upper end of this range (58 U/L or greater) will be withdrawn from the study per study stopping criteria. This value will be reported as: "Number of participants with normal ALT levels," "Number of participants with abnormal ALT values," and "Number of participants withdrawn from the study based on elevated ALT values."
Measured: Mean change in Screening ALT values at 4 weeks.
Alanine aminotransferase (ALT)
Alanine aminotransferase is an enzyme that is often measured in blood as an indication of liver toxicity. This value is reported as cubic rack units (U) per liter (L); (U/L). Normal ranges are 6-29 U/L. Any participant with a value of 2 times or higher of the upper end of this range (58 U/L or greater) will be withdrawn from the study per study stopping criteria. This value will be reported as: "Number of participants with normal ALT levels," "Number of participants with abnormal ALT values," and "Number of participants withdrawn from the study based on elevated ALT values."
Measured: Mean change in Screening ALT values at 8 weeks.
Alanine aminotransferase (ALT)
Alanine aminotransferase is an enzyme that is often measured in blood as an indication of liver toxicity. This value is reported as cubic rack units (U) per liter (L); (U/L). Normal ranges are 6-29 U/L. Any participant with a value of 2 times or higher of the upper end of this range (58 U/L or greater) will be withdrawn from the study per study stopping criteria. This value will be reported as: "Number of participants with normal ALT levels," "Number of participants with abnormal ALT values," and "Number of participants withdrawn from the study based on elevated ALT values."
Measured: Mean change in 4 weeks ALT values at 8 weeks.
Estimated glomerular filtration rate (eGFR)
Glomerular filtration rate is estimated based on blood creatinine concentration per standard nephrology practice. This value is reported as milliliters/minute/1.73m2 (mL/min/1.73m2). An eGFR value is considered normal if it is 60 or greater mL/min/1.73m2, and abnormal if it is less than 60 mL/min/1.73m2. Results will be reported as normal (60 or greater mL/min/1.73m2) or abnormal (less than 60 mL/min/1.73m2). Participants will be withdrawn from the study if two consecutive readings of eGFR show a decrease in eGFR of 15 mL/min/1.73m2 or greater.
Measured: Mean change in Screening eGFR value at 4 weeks.
Estimated glomerular filtration rate (eGFR)
Glomerular filtration rate is estimated based on blood creatinine concentration per standard nephrology practice. This value is reported as milliliters/minute/1.73m2 (mL/min/1.73m2). An eGFR value is considered normal if it is 60 or greater mL/min/1.73m2, and abnormal if it is less than 60 mL/min/1.73m2. Results will be reported as normal (60 or greater mL/min/1.73m2) or abnormal (less than 60 mL/min/1.73m2). Participants will be withdrawn from the study if two consecutive readings of eGFR show a decrease in eGFR of 15 mL/min/1.73m2 or greater.
Measured: Mean change in Screening eGFR value at 8 weeks.
Estimated glomerular filtration rate (eGFR)
Glomerular filtration rate is estimated based on blood creatinine concentration per standard nephrology practice. This value is reported as milliliters/minute/1.73m2 (mL/min/1.73m2). An eGFR value is considered normal if it is 60 or greater mL/min/1.73m2, and abnormal if it is less than 60 mL/min/1.73m2. Results will be reported as normal (60 or greater mL/min/1.73m2) or abnormal (less than 60 mL/min/1.73m2). Participants will be withdrawn from the study if two consecutive readings of eGFR show a decrease in eGFR of 15 mL/min/1.73m2 or greater.
Measured: Mean change in 4 weeks eGFR value at 8 weeks.
International normalized ratio
Prothrombin time (PT) measures the ability of the blood to form blood clots through hemostasis. Partial thromboplastin time (PTT) also assess the ability to form blood clots through hemostasis, as well as amount and functions of proteins that initiate the clotting process (coagulation factors). PT and PTT will be combined to calculate the International Normalized Ratio (INR). INR is a calculation based on PT and PTT that measures the ability to form blood clots. INR values are dimensionless and will be reported numerically. A value less than 2.0 is considered normal. Any values of 2.0 or greater are considered abnormal and will result in exclusion from the study. If 25% or more of the study participants have INR values of 2.0 or greater at any point during the study period, the study will end and all participants will be withdrawn. Reported as numerical values of INR, percent of participants withdrawn from the study based on INR values of 2.0 or greater, and study stopping criteria.
Measured: Mean change in Screening INR value at 4 weeks.
International normalized ratio
Prothrombin time (PT) measures the ability of the blood to form blood clots through hemostasis. Partial thromboplastin time (PTT) also assess the ability to form blood clots through hemostasis, as well as amount and functions of proteins that initiate the clotting process (coagulation factors). PT and PTT will be combined to calculate the International Normalized Ratio (INR). INR is a calculation based on PT and PTT that measures the ability to form blood clots. INR values are dimensionless and will be reported numerically. A value less than 2.0 is considered normal. Any values of 2.0 or greater are considered abnormal and will result in exclusion from the study. If 25% or more of the study participants have INR values of 2.0 or greater at any point during the study period, the study will end and all participants will be withdrawn. Reported as numerical values of INR, percent of participants withdrawn from the study based on INR values of 2.0 or greater, and study stopping criteria.
Measured: Mean change in Screening INR value at 8 weeks.
International normalized ratio
Prothrombin time (PT) measures the ability of the blood to form blood clots through hemostasis. Partial thromboplastin time (PTT) also assess the ability to form blood clots through hemostasis, as well as amount and functions of proteins that initiate the clotting process (coagulation factors). PT and PTT will be combined to calculate the International Normalized Ratio (INR). INR is a calculation based on PT and PTT that measures the ability to form blood clots. INR values are dimensionless and will be reported numerically. A value less than 2.0 is considered normal. Any values of 2.0 or greater are considered abnormal and will result in exclusion from the study. If 25% or more of the study participants have INR values of 2.0 or greater at any point during the study period, the study will end and all participants will be withdrawn. Reported as numerical values of INR, percent of participants withdrawn from the study based on INR values of 2.0 or greater, and study stopping criteria.
Measured: Mean change in 4 weeks INR value at 8 weeks.
Systolic Blood pressure
Blood pressure is used to assess hemodynamic stability by measuring the pressure of circulating blood on the walls of blood vessels. Systolic pressure will be assessed during the study period. Reported as: hypotension (less than 90 mmHg), normal blood pressure (90-139 mmHg), or hypertension (140 or greater mmHg). 2 consecutive readings of hypotension or hypertension will results in withdrawal from the study. Readings of systolic blood pressure from participants who complete the study will be reported in a table showing both systolic and diastolic readings at each time point assessed (Baseline and 4 weeks).
Measured: Mean change from Baseline systolic blood pressure at 4 weeks.
Systolic Blood pressure
Blood pressure is used to assess hemodynamic stability by measuring the pressure of circulating blood on the walls of blood vessels. Systolic pressure will be assessed during the study period. Reported as: hypotension (less than 90 mmHg), normal blood pressure (90-139 mmHg), or hypertension (140 or greater mmHg). 2 consecutive readings of hypotension or hypertension will results in withdrawal from the study. Readings of systolic blood pressure from participants who complete the study will be reported in a table showing both systolic and diastolic readings at each time point assessed (Baseline and 8 weeks).
Measured: Mean change from Baseline systolic blood pressure at 8 weeks.
Systolic Blood pressure
Blood pressure is used to assess hemodynamic stability by measuring the pressure of circulating blood on the walls of blood vessels. Systolic pressure will be assessed during the study period. Reported as: hypotension (less than 90 mmHg), normal blood pressure (90-139 mmHg), or hypertension (140 or greater mmHg). 2 consecutive readings of hypotension or hypertension will results in withdrawal from the study. Readings of systolic blood pressure from participants who complete the study will be reported in a table showing both systolic and diastolic readings at each time point assessed (4 weeks and 8 weeks).
Measured: Mean change from 4 weeks systolic blood pressure at 8 weeks.
Diastolic Blood pressure
Blood pressure is used to assess hemodynamic stability by measuring the pressure of circulating blood on the walls of blood vessels. Diastolic pressure will be assessed during the study period. Reported as: hypotension (less than 60 mmHg), normal blood pressure (60-89 mmHg), or hypertension (90 or greater mmHg). 2 consecutive readings of hypotension or hypertension will results in withdrawal from the study. Readings of blood pressure from participants who complete the study will be reported in a table showing both systolic and diastolic readings at each time point assessed (Baseline and 4 weeks).
Measured: Mean change from Baseline diastolic blood pressure at 4 weeks.
Diastolic Blood pressure
Blood pressure is used to assess hemodynamic stability by measuring the pressure of circulating blood on the walls of blood vessels. Diastolic pressure will be assessed during the study period. Reported as: hypotension (less than 60 mmHg), normal blood pressure (60-89 mmHg), or hypertension (90 or greater mmHg). 2 consecutive readings of hypotension or hypertension will results in withdrawal from the study. Readings of blood pressure from participants who complete the study will be reported in a table showing both systolic and diastolic readings at each time point assessed (Baseline and 8 weeks).
Measured: Mean change from Baseline diastolic blood pressure at 8 weeks.
Diastolic Blood pressure
Blood pressure is used to assess hemodynamic stability by measuring the pressure of circulating blood on the walls of blood vessels. Diastolic pressure will be assessed during the study period. Reported as: hypotension (less than 60 mmHg), normal blood pressure (60-89 mmHg), or hypertension (90 or greater mmHg). 2 consecutive readings of hypotension or hypertension will results in withdrawal from the study. Readings of blood pressure from participants who complete the study will be reported in a table showing both systolic and diastolic readings at each time point assessed (4 weeks and 8 weeks).
Measured: Mean change from 4 weeks diastolic blood pressure at 8 weeks.

Secondary outcomes (11)

Anxiety Subscore Patient Reported Outcomes Measurement Information System 29 (PROMIS-29)
The Patient Reported Outcomes Measurement Information System 29 (PROMIS-29) measures is a survey designed to measure self-reported physical, mental, and social health and wellbeing. This survey consists of 7 subscale scores, including: symptom-oriented subscores (anxiety, depression, fatigue, pain interference, and sleep disturbance) and function-oriented domains (physical functioning and social role). The anxiety subscale score ranges from 4-20, with a higher score indicating higher anxiety and a lower score indicating lower anxiety. Reported as a subscale.
Measured: Mean change in Baseline Anxiety Score and 8 weeks.
Depression Subscore of the Patient Reported Outcomes Measurement Information System 29 (PROMIS-29)
The Patient Reported Outcomes Measurement Information System 29 (PROMIS-29) measures is a survey designed to measure self-reported physical, mental, and social health and wellbeing. This survey consists of 7 subscale scores, including: symptom-oriented subscores (anxiety, depression, fatigue, pain interference, and sleep disturbance) and function-oriented domains (physical functioning and social role). The depression subscale score ranges from 4-20, with a higher score indicating more depression and a lower score indicating less depression. Reported as a subscale.
Measured: Mean change in Baseline Depression Score and 8 weeks.
Fatigue Subscore of the Patient Reported Outcomes Measurement Information System 29 (PROMIS-29)
The Patient Reported Outcomes Measurement Information System 29 (PROMIS-29) measures is a survey designed to measure self-reported physical, mental, and social health and wellbeing. This survey consists of 7 subscale scores, including: symptom-oriented subscores (anxiety, depression, fatigue, pain interference, and sleep disturbance) and function-oriented domains (physical functioning and social role). The fatigue subscale score ranges from 4-20, with a higher score indicating more fatigue and a lower score indicating less fatigue. Reported as a subscale.
Measured: Mean change in Baseline Fatigue Score and 8 weeks.
Pain Interference Subscore of the Patient Reported Outcomes Measurement Information System 29 (PROMIS-29)
The Patient Reported Outcomes Measurement Information System 29 (PROMIS-29) measures is a survey designed to measure self-reported physical, mental, and social health and wellbeing. This survey consists of 7 subscale scores, including: symptom-oriented subscores (anxiety, depression, fatigue, pain interference, and sleep disturbance) and function-oriented domains (physical functioning and social role). The pain interference subscale score ranges from 4-20, with a higher score indicating more pain interference and a lower score indicating less pain interference. Reported as a subscale.
Measured: Mean change in Baseline Pain Interference Score and 8 weeks.
Sleep Disturbance Subscore of the Patient Reported Outcomes Measurement Information System 29 (PROMIS-29)
The Patient Reported Outcomes Measurement Information System 29 (PROMIS-29) measures is a survey designed to measure self-reported physical, mental, and social health and wellbeing. This survey consists of 7 subscale scores, including: symptom-oriented subscores (anxiety, depression, fatigue, pain interference, and sleep disturbance) and function-oriented domains (physical functioning and social role). The sleep disturbance subscale score ranges from 4-20, with a higher score indicating more sleep disturbance and a lower score indicating less sleep disturbance. Reported as a subscale.
Measured: Mean change in Baseline Sleep Disturbance Score and 8 weeks.
Physical Functioning Subscore of the Patient Reported Outcomes Measurement Information System 29 (PROMIS-29)
The Patient Reported Outcomes Measurement Information System 29 (PROMIS-29) measures is a survey designed to measure self-reported physical, mental, and social health and wellbeing. This survey consists of 7 subscale scores, including: symptom-oriented subscores (anxiety, depression, fatigue, pain interference, and sleep disturbance) and function-oriented domains (physical functioning and social role). The physical functioning subscale score ranges from 4-20, with a higher score indicating more physical function and a lower score indicating less physical function. Reported as a subscale.
Measured: Mean change in Baseline Physical Functioning Score and 8 weeks.
Social Role Subscore of the Patient Reported Outcomes Measurement Information System 29 (PROMIS-29)
The Patient Reported Outcomes Measurement Information System 29 (PROMIS-29) measures is a survey designed to measure self-reported physical, mental, and social health and wellbeing. This survey consists of 7 subscale scores, including: symptom-oriented subscores (anxiety, depression, fatigue, pain interference, and sleep disturbance) and function-oriented domains (physical functioning and social role). The social role subscale score ranges from 4-20, with a higher score indicating more ability to participate in social roles and activities and a lower score indicating less ability to participate in social roles and activities. Reported as a subscale.
Measured: Mean change in Baseline Social Role Score and 8 weeks.
Visual Analog Scale (VAS)
The Visual Analog Scale (VAS) is a psychometric response scale used to measure the intensity of pain. Pain is a subjective measure and pain intensity is used to quantify how much a person believes they are in pain. This scale ranges from 0-10, with lower scores indicating less subjective pain and higher scores indicating more subjective pain. This will be reported as change in a numerical value.
Measured: Mean change in Baseline VAS Score and 4 weeks.
Visual Analog Scale (VAS)
The Visual Analog Scale (VAS) is a psychometric response scale used to measure the intensity of pain. Pain is a subjective measure and pain intensity is used to quantify how much a person believes they are in pain. This scale ranges from 0-10, with lower scores indicating less subjective pain and higher scores indicating more subjective pain. This will be reported as change in a numerical value.
Measured: Mean change in Baseline VAS Score and 8 weeks.
Visual Analog Scale (VAS)
The Visual Analog Scale (VAS) is a psychometric response scale used to measure the intensity of pain. Pain is a subjective measure and pain intensity is used to quantify how much a person believes they are in pain. This scale ranges from 0-10, with lower scores indicating less subjective pain and higher scores indicating more subjective pain. This will be reported as change in a numerical value.
Measured: Mean change in 4 weeks VAS Score and 8 weeks.
Patient Reported Outcomes Measurement Information System (PROMIS) Sexual Function Measure
The Patient Reported Outcomes Measurement Information System (PROMIS) Sexual Function Measure measures sexual function and evaluation of sexual experiences over the past 30 days. It is a subjective measure with 10 questions. These include domains such as: interest in sexual activity, lubrication during sexual activity, physical comfort during sexual activity, physical pain during sexual activity, orgasm during sexual activity, and overall satisfaction with sexual activity. This measure is scored using the HealthMeasures Scoring Device, with higher scores indicating better sexual function and lower scores indicating worse sexual function.
Measured: Mean change in Baseline PROMIS Sexual Function Score and 8 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jul 201915 Dec 2022

First posted29 Jan 2020
Study start30 Jul 2019
Primary completion1 Jan 2022
Study completion15 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Model description: Single arm, open-label trial evaluating safety and tolerability.
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04245540
Sponsor's protocol ID: RB11617
Acronym: EPAPD
Status last verified: Mar 2023
First submitted: 16 May 2018
Last updated: 24 Mar 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Proctor M, Farquhar C. Diagnosis and management of dysmenorrhoea. BMJ. 2006 May 13;332(7550):1134-8. doi: 10.1136/bmj.332.7550.1134. No abstract available.
PubMed 16690671
Osayande AS, Mehulic S. Diagnosis and initial management of dysmenorrhea. Am Fam Physician. 2014 Mar 1;89(5):341-6.
PubMed 24695505
Zahradnik HP, Hanjalic-Beck A, Groth K. Nonsteroidal anti-inflammatory drugs and hormonal contraceptives for pain relief from dysmenorrhea: a review. Contraception. 2010 Mar;81(3):185-96. doi: 10.1016/j.contraception.2009.09.014. Epub 2009 Nov 6.
PubMed 20159173
Halter F, Tarnawski AS, Schmassmann A, Peskar BM. Cyclooxygenase 2-implications on maintenance of gastric mucosal integrity and ulcer healing: controversial issues and perspectives. Gut. 2001 Sep;49(3):443-53. doi: 10.1136/gut.49.3.443.
PubMed 11511570
Lee JH, Cheong J, Park YM, Choi YH. Down-regulation of cyclooxygenase-2 and telomerase activity by beta-lapachone in human prostate carcinoma cells. Pharmacol Res. 2005 Jun;51(6):553-60. doi: 10.1016/j.phrs.2005.02.004.
PubMed 15829436
Twardowschy A, Freitas CS, Baggio CH, Mayer B, dos Santos AC, Pizzolatti MG, Zacarias AA, dos Santos EP, Otuki MF, Marques MC. Antiulcerogenic activity of bark extract of Tabebuia avellanedae, Lorentz ex Griseb. J Ethnopharmacol. 2008 Aug 13;118(3):455-9. doi: 10.1016/j.jep.2008.05.013. Epub 2008 May 18.
PubMed 18579323
Pereira IT, Burci LM, da Silva LM, Baggio CH, Heller M, Micke GA, Pizzolatti MG, Marques MC, Werner MF. Antiulcer effect of bark extract of Tabebuia avellanedae: activation of cell proliferation in gastric mucosa during the healing process. Phytother Res. 2013 Jul;27(7):1067-73. doi: 10.1002/ptr.4835. Epub 2012 Sep 12.
PubMed 22969019
Giacomelli I, Scartoni D, Fiammetta M, Baki M, Zei G, Muntoni C, Cappelli S, Greto D, Scoccianti S, Livi L. Oral Lapacho-Based Medication: An Easy, Safe, and Feasible Support to Prevent and/or Reduce Oral Mucositis During Radiotherapy for Head and Neck Cancer. Nutr Cancer. 2015;67(8):1247-53. doi: 10.1080/01635581.2015.1082114. Epub 2015 Oct 9.
PubMed 26451712
Lee MH, Choi HM, Hahm DH, Her E, Yang HI, Yoo MC, Kim KS. Analgesic and anti-inflammatory effects in animal models of an ethanolic extract of Taheebo, the inner bark of Tabebuia avellanedae. Mol Med Rep. 2012 Oct;6(4):791-6. doi: 10.3892/mmr.2012.989. Epub 2012 Jul 17.
PubMed 22825254
de Miranda FG, Vilar JC, Alves IA, Cavalcanti SC, Antoniolli AR. Antinociceptive and antiedematogenic properties and acute toxicity of Tabebuia avellanedae Lor. ex Griseb. inner bark aqueous extract. BMC Pharmacol. 2001;1:6. doi: 10.1186/1471-2210-1-6. Epub 2001 Sep 13.
PubMed 11574048
Lira AA, Sester EA, Carvalho AL, Strattmann RR, Albuquerque MM, Wanderley AG, Santana DP. Development of lapachol topical formulation: anti-inflammatory study of a selected formulation. AAPS PharmSciTech. 2008;9(1):163-8. doi: 10.1208/s12249-007-9002-z. Epub 2008 Jan 25.
PubMed 18446477
de Almeida ER, da Silva Filho AA, dos Santos ER, Lopes CA. Antiinflammatory action of lapachol. J Ethnopharmacol. 1990 May;29(2):239-41. doi: 10.1016/0378-8741(90)90061-w. No abstract available.
PubMed 2374436

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Study at a glance

From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single Arm, Open-label Pilot Trial Examining the Effects of Pau d' Arco on Primary Dysmenorrhea in Reproductive Age Women
ClinicalTrials.gov ID: NCT04245540
Acronym / sponsor ID: EPAPD / RB11617
Conditions: Primary Dysmenorrhea
Keywords: primary dysmenorrhea, dysmenorrhea, tabebuia avellanedae, tabebuia impetiginosa, pau d' arco, taheebo bark, menstrual pain, pelvic pain
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: National University of Natural MedicineUniversity, hospital or other
Study start: 30 Jul 2019 (actual)
Primary completion: 1 Jan 2022 (actual)
Study completion: 15 Dec 2022 (actual)
First posted: 29 Jan 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Single arm, open-label trial evaluating safety and tolerability.

Arm	Type	Receives
Active	Experimental	Dietary Supplement: Pau d' Arco1,050 mg per day of encapsulated Pau d' Arco taken orally for 2 months.

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (13 listed)

Biologically female
Ages 18-45
Presence of primary dysmenorrhea
Has a 'smart' phone and is willing to download and use an electronic application for use during the study.
Willing to take a non-hormonal form of birth control throughout the trial period (abstinence, condom, diaphragm, or copper IUD (ParaGard))

Key exclusion criteria (42 listed)

Presence of secondary dysmenorrhea
General health measures outside of normal range:
Women who are nursing, pregnant, or planning pregnancy in the next four months
Difficulty swallowing or aversion to capsules, tablets, or pills
Currently taking, and unwilling to discontinue, NSAIDs (Aspirin, Ibuprofen)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pau d' ArcoEncapsulated herbal Pau d' Arco.	Dietary supplement	Active

Primary outcome

Red Blood Cell Count
Time frame: Mean change in Screening RBC count to 4 weeks.
Red blood cell count will be collected through a Complete Blood Count (CBC) test. Normal ranges for this test are 3.80-5.10 Million/uL. Red blood cell (RBC) count of less than 3.80 Million/uL will be considered as new onset anemia and will result in the participant being withdrawn from the study. This measure will be reported as: "Number of participants with normal RBC count levels," "Number of participants with abnormal RBC count values," and "Number of participants withdrawn from the study based on decreased RBC count values."
Red Blood Cell Count
Time frame: Mean change in Screening RBC count to 8 weeks.
Red blood cell count will be collected through a Complete Blood Count (CBC) test. Normal ranges for this test are 3.80-5.10 Million/uL. Red blood cell (RBC) count of less than 3.80 Million/uL will be considered as new onset anemia and will result in the participant being withdrawn from the study. This measure will be reported as: "Number of participants with normal RBC count levels," "Number of participants with abnormal RBC count values," and "Number of participants withdrawn from the study based on decreased RBC count values."
Red Blood Cell Count
Time frame: Mean change in 4 weeks RBC count to 8 weeks.
Red blood cell count will be collected through a Complete Blood Count (CBC) test. Normal ranges for this test are 3.80-5.10 Million/uL. Red blood cell (RBC) count of less than 3.80 Million/uL will be considered as new onset anemia and will result in the participant being withdrawn from the study. This measure will be reported as: "Number of participants with normal RBC count levels," "Number of participants with abnormal RBC count values," and "Number of participants withdrawn from the study based on decreased RBC count values."
Hemoglobin
Time frame: Mean change in Screening Hemoglobin g/dL to 4 weeks.
Hemoglobin is a protein in red blood cells that carries oxygen throughout the body. Hemoglobin will be collected through a Complete Blood Count (CBC) test. Normal ranges for this test are 11.7-15.5 grams per deciliter (g/dL). Hemoglobin of less than 11.7 g/dL or greater than 15.5 g/dL will be considered as abnormal. This measure will be reported as: "Number of participants with normal Hemoglobin levels" and "Number of participants with abnormal Hemoglobin values."
Hemoglobin
Time frame: Mean change in Screening Hemoglobin g/dL to 8 weeks.
Hemoglobin is a protein in red blood cells that carries oxygen throughout the body. Hemoglobin will be collected through a Complete Blood Count (CBC) test. Normal ranges for this test are 11.7-15.5 grams per deciliter (g/dL). Hemoglobin of less than 11.7 g/dL or greater than 15.5 g/dL will be considered as abnormal. This measure will be reported as: "Number of participants with normal Hemoglobin levels" and "Number of participants with abnormal Hemoglobin values."
Hemoglobin
Time frame: Mean change in 4 weeks Hemoglobin g/dL to 8 weeks.
Hemoglobin is a protein in red blood cells that carries oxygen throughout the body. Hemoglobin will be collected through a Complete Blood Count (CBC) test. Normal ranges for this test are 11.7-15.5 grams per deciliter (g/dL. Hemoglobin of less than 11.7 g/dL or greater than 15.5 g/dL will be considered as abnormal. This measure will be reported as: "Number of participants with normal Hemoglobin levels" and "Number of participants with abnormal Hemoglobin values."
Hematocrit
Time frame: Mean change in Screening Hematocrit % to 4 weeks.
Hematocrit is the ratio of the volume of red blood cells to the total volume of blood. Hematocrit will be collected through a Complete Blood Count (CBC) test. Normal ranges for this test are 35.0-45.0 %. Hemoglobin of less than 35.0% or greater than 45.0% will be considered as abnormal. This measure will be reported as: "Number of participants with normal Hemotocrit % levels" and "Number of participants with abnormal Hematocrit % values."
Hematocrit
Time frame: Mean change in Screening Hematocrit % to 8 weeks.
Hematocrit is the ratio of the volume of red blood cells to the total volume of blood. Hematocrit will be collected through a Complete Blood Count (CBC) test. Normal ranges for this test are 35.0-45.0 %. Hemoglobin of less than 35.0% or greater than 45.0% will be considered as abnormal. This measure will be reported as: "Number of participants with normal Hemotocrit % levels" and "Number of participants with abnormal Hematocrit % values."
Hematocrit
Time frame: Mean change in 4 weeks Hematocrit % to 8 weeks.
Hematocrit is the ratio of the volume of red blood cells to the total volume of blood. Hematocrit will be collected through a Complete Blood Count (CBC) test. Normal ranges for this test are 35.0-45.0 %. Hemoglobin of less than 35.0% or greater than 45.0% will be considered as abnormal. This measure will be reported as: "Number of participants with normal Hemotocrit % levels" and "Number of participants with abnormal Hematocrit % values."
Mean Corpuscular Volume
Time frame: Mean change in Screening MCV fL to 4 weeks.
Mean Corpuscular Volume (MCV) measures the average red blood cell volume. MCV will be collected through a Complete Blood Count (CBC) test. Normal ranges for this test are 80.0-100.0 femtolitre (fL). MCV of less than 80.0 fL or greater than 100.0 fL will be considered as abnormal. This measure will be reported as: "Number of participants with normal MCV fL levels" and "Number of participants with abnormal MCV fL values."
Mean Corpuscular Volume
Time frame: Mean change in Screening MCV fL to 8 weeks.
Mean Corpuscular Volume (MCV) measures the average red blood cell volume. MCV will be collected through a Complete Blood Count (CBC) test. Normal ranges for this test are 80.0-100.0 femtolitre (fL). MCV of less than 80.0 fL or greater than 100.0 fL will be considered as abnormal. This measure will be reported as: "Number of participants with normal MCV fL levels" and "Number of participants with abnormal MCV fL values."
Mean Corpuscular Volume
Time frame: Mean change in 4 weeks MCV fL to 8 weeks.
Mean Corpuscular Volume (MCV) measures the average red blood cell volume. MCV will be collected through a Complete Blood Count (CBC) test. Normal ranges for this test are 80.0-100.0 femtolitre (fL). MCV of less than 80.0 fL or greater than 100.0 fL will be considered as abnormal. This measure will be reported as: "Number of participants with normal MCV fL levels" and "Number of participants with abnormal MCV fL values."
Mean Corpuscular Hemoglobin
Time frame: Mean change in Screening MCH pg to 4 weeks.
Mean Corpuscular Hemoglobin (MCH) measures the average mass of hemoglobin per red blood cell. MCH will be collected through a Complete Blood Count (CBC) test. Normal ranges for this test are 27.0-33.0 picogram (pg). MCH of less than 27.0 pg or greater than 33.0 pg will be considered as abnormal. This measure will be reported as: "Number of participants with normal MCH pg levels" and "Number of participants with abnormal MCH pg values."
Mean Corpuscular Hemoglobin
Time frame: Mean change in Screening MCH pg to 8 weeks.
Mean Corpuscular Hemoglobin (MCH) measures the average mass of hemoglobin per red blood cell. MCH will be collected through a Complete Blood Count (CBC) test. Normal ranges for this test are 27.0-33.0 picogram (pg). MCH of less than 27.0 pg or greater than 33.0 pg will be considered as abnormal. This measure will be reported as: "Number of participants with normal MCH pg levels" and "Number of participants with abnormal MCH pg values."
Mean Corpuscular Hemoglobin
Time frame: Mean change in 4 weeks MCH pg to 8 weeks.
Mean Corpuscular Hemoglobin (MCH) measures the average mass of hemoglobin per red blood cell. MCH will be collected through a Complete Blood Count (CBC) test. Normal ranges for this test are 27.0-33.0 picogram (pg). MCH of less than 27.0 pg or greater than 33.0 pg will be considered as abnormal. This measure will be reported as: "Number of participants with normal MCH pg levels" and "Number of participants with abnormal MCH pg values."
Mean Corpuscular Hemoglobin Concentration
Time frame: Mean change in 4 weeks MCH pg to 8 weeks.
Mean Corpuscular Hemoglobin Concentration (MCHC) measures the average mass of hemoglobin per red blood cell. MCH will be collected through a Complete Blood Count (CBC) test. Normal ranges for this test are 27.0-33.0 picogram (pg). MCH of less than 27.0 pg or greater than 33.0 pg will be considered as abnormal. This measure will be reported as: "Number of participants with normal MCH pg levels" and "Number of participants with abnormal MCH pg values."
Recruitment and retention.
Time frame: Percent change from Baseline Recruitment to 8 weeks.
Recruitment of 12 women with primary dysmenorrhea and retention of at least 10 participants throughout the course of the study. Reported as number of recruited participants, number of excluded participants, and number of drop out participants.
Incidence of Intervention-attributable Adverse Events
Time frame: Percent change from Baseline Intervention-attributable Adverse Events to 4 weeks.
Self-reported adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events. Reported as: New onset "FDA serious" adverse events; New onset "moderate" adverse events; all reported adverse events
Incidence of Intervention-attributable Adverse Events
Time frame: Percent change from Baseline Intervention-attributable Adverse Events to 8 weeks.
Self-reported adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events. Reported as: New onset "FDA serious" adverse events; New onset "moderate" adverse events; all reported adverse events
Incidence of Intervention-attributable Adverse Events
Time frame: Percent from 4 weeks Intervention-attributable Adverse Events to 8 weeks.
Self-reported adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events. Reported as: New onset "FDA serious" adverse events; New onset "moderate" adverse events; all reported adverse events
Aspartate aminotransferase (AST)
Time frame: Mean change in Screening AST values at 4 weeks.
Aspartate aminotransferase is an enzyme that is often measured in blood as an indication of liver toxicity. This value is reported as cubic rack units (U) per liter (L); (U/L). Normal ranges are 10-30 U/L. Any participant with a value of 2 times or higher of the upper end of this range (60 U/L or greater) will be withdrawn from the study per study stopping criteria. This value will be reported as: "Number of participants with normal AST levels," "Number of participants with abnormal AST values," and "Number of participants withdrawn from the study based on elevated AST values."
Aspartate aminotransferase (AST)
Time frame: Mean change in Screening AST values at 8 weeks.
Aspartate aminotransferase is an enzyme that is often measured in blood as an indication of liver toxicity. This value is reported as cubic rack units (U) per liter (L); (U/L). Normal ranges are 10-30 U/L. Any participant with a value of 2 times or higher of the upper end of this range (60 U/L or greater) will be withdrawn from the study per study stopping criteria. This value will be reported as: "Number of participants with normal AST levels," "Number of participants with abnormal AST values," and "Number of participants withdrawn from the study based on elevated AST values."
Aspartate aminotransferase (AST)
Time frame: Mean change in 4 weeks AST values at 8 weeks.
Aspartate aminotransferase is an enzyme that is often measured in blood as an indication of liver toxicity. This value is reported as cubic rack units (U) per liter (L); (U/L). Normal ranges are 10-30 U/L. Any participant with a value of 2 times or higher of the upper end of this range (60 U/L or greater) will be withdrawn from the study per study stopping criteria. This value will be reported as: "Number of participants with normal AST levels," "Number of participants with abnormal AST values," and "Number of participants withdrawn from the study based on elevated AST values."
Alanine aminotransferase (ALT)
Time frame: Mean change in Screening ALT values at 4 weeks.
Alanine aminotransferase is an enzyme that is often measured in blood as an indication of liver toxicity. This value is reported as cubic rack units (U) per liter (L); (U/L). Normal ranges are 6-29 U/L. Any participant with a value of 2 times or higher of the upper end of this range (58 U/L or greater) will be withdrawn from the study per study stopping criteria. This value will be reported as: "Number of participants with normal ALT levels," "Number of participants with abnormal ALT values," and "Number of participants withdrawn from the study based on elevated ALT values."
Alanine aminotransferase (ALT)
Time frame: Mean change in Screening ALT values at 8 weeks.
Alanine aminotransferase is an enzyme that is often measured in blood as an indication of liver toxicity. This value is reported as cubic rack units (U) per liter (L); (U/L). Normal ranges are 6-29 U/L. Any participant with a value of 2 times or higher of the upper end of this range (58 U/L or greater) will be withdrawn from the study per study stopping criteria. This value will be reported as: "Number of participants with normal ALT levels," "Number of participants with abnormal ALT values," and "Number of participants withdrawn from the study based on elevated ALT values."
Alanine aminotransferase (ALT)
Time frame: Mean change in 4 weeks ALT values at 8 weeks.
Alanine aminotransferase is an enzyme that is often measured in blood as an indication of liver toxicity. This value is reported as cubic rack units (U) per liter (L); (U/L). Normal ranges are 6-29 U/L. Any participant with a value of 2 times or higher of the upper end of this range (58 U/L or greater) will be withdrawn from the study per study stopping criteria. This value will be reported as: "Number of participants with normal ALT levels," "Number of participants with abnormal ALT values," and "Number of participants withdrawn from the study based on elevated ALT values."
Estimated glomerular filtration rate (eGFR)
Time frame: Mean change in Screening eGFR value at 4 weeks.
Glomerular filtration rate is estimated based on blood creatinine concentration per standard nephrology practice. This value is reported as milliliters/minute/1.73m2 (mL/min/1.73m2). An eGFR value is considered normal if it is 60 or greater mL/min/1.73m2, and abnormal if it is less than 60 mL/min/1.73m2. Results will be reported as normal (60 or greater mL/min/1.73m2) or abnormal (less than 60 mL/min/1.73m2). Participants will be withdrawn from the study if two consecutive readings of eGFR show a decrease in eGFR of 15 mL/min/1.73m2 or greater.
Estimated glomerular filtration rate (eGFR)
Time frame: Mean change in Screening eGFR value at 8 weeks.
Glomerular filtration rate is estimated based on blood creatinine concentration per standard nephrology practice. This value is reported as milliliters/minute/1.73m2 (mL/min/1.73m2). An eGFR value is considered normal if it is 60 or greater mL/min/1.73m2, and abnormal if it is less than 60 mL/min/1.73m2. Results will be reported as normal (60 or greater mL/min/1.73m2) or abnormal (less than 60 mL/min/1.73m2). Participants will be withdrawn from the study if two consecutive readings of eGFR show a decrease in eGFR of 15 mL/min/1.73m2 or greater.
Estimated glomerular filtration rate (eGFR)
Time frame: Mean change in 4 weeks eGFR value at 8 weeks.
Glomerular filtration rate is estimated based on blood creatinine concentration per standard nephrology practice. This value is reported as milliliters/minute/1.73m2 (mL/min/1.73m2). An eGFR value is considered normal if it is 60 or greater mL/min/1.73m2, and abnormal if it is less than 60 mL/min/1.73m2. Results will be reported as normal (60 or greater mL/min/1.73m2) or abnormal (less than 60 mL/min/1.73m2). Participants will be withdrawn from the study if two consecutive readings of eGFR show a decrease in eGFR of 15 mL/min/1.73m2 or greater.
International normalized ratio
Time frame: Mean change in Screening INR value at 4 weeks.
Prothrombin time (PT) measures the ability of the blood to form blood clots through hemostasis. Partial thromboplastin time (PTT) also assess the ability to form blood clots through hemostasis, as well as amount and functions of proteins that initiate the clotting process (coagulation factors). PT and PTT will be combined to calculate the International Normalized Ratio (INR). INR is a calculation based on PT and PTT that measures the ability to form blood clots. INR values are dimensionless and will be reported numerically. A value less than 2.0 is considered normal. Any values of 2.0 or greater are considered abnormal and will result in exclusion from the study. If 25% or more of the study participants have INR values of 2.0 or greater at any point during the study period, the study will end and all participants will be withdrawn. Reported as numerical values of INR, percent of participants withdrawn from the study based on INR values of 2.0 or greater, and study stopping criteria.
International normalized ratio
Time frame: Mean change in Screening INR value at 8 weeks.
Prothrombin time (PT) measures the ability of the blood to form blood clots through hemostasis. Partial thromboplastin time (PTT) also assess the ability to form blood clots through hemostasis, as well as amount and functions of proteins that initiate the clotting process (coagulation factors). PT and PTT will be combined to calculate the International Normalized Ratio (INR). INR is a calculation based on PT and PTT that measures the ability to form blood clots. INR values are dimensionless and will be reported numerically. A value less than 2.0 is considered normal. Any values of 2.0 or greater are considered abnormal and will result in exclusion from the study. If 25% or more of the study participants have INR values of 2.0 or greater at any point during the study period, the study will end and all participants will be withdrawn. Reported as numerical values of INR, percent of participants withdrawn from the study based on INR values of 2.0 or greater, and study stopping criteria.
International normalized ratio
Time frame: Mean change in 4 weeks INR value at 8 weeks.
Prothrombin time (PT) measures the ability of the blood to form blood clots through hemostasis. Partial thromboplastin time (PTT) also assess the ability to form blood clots through hemostasis, as well as amount and functions of proteins that initiate the clotting process (coagulation factors). PT and PTT will be combined to calculate the International Normalized Ratio (INR). INR is a calculation based on PT and PTT that measures the ability to form blood clots. INR values are dimensionless and will be reported numerically. A value less than 2.0 is considered normal. Any values of 2.0 or greater are considered abnormal and will result in exclusion from the study. If 25% or more of the study participants have INR values of 2.0 or greater at any point during the study period, the study will end and all participants will be withdrawn. Reported as numerical values of INR, percent of participants withdrawn from the study based on INR values of 2.0 or greater, and study stopping criteria.
Systolic Blood pressure
Time frame: Mean change from Baseline systolic blood pressure at 4 weeks.
Blood pressure is used to assess hemodynamic stability by measuring the pressure of circulating blood on the walls of blood vessels. Systolic pressure will be assessed during the study period. Reported as: hypotension (less than 90 mmHg), normal blood pressure (90-139 mmHg), or hypertension (140 or greater mmHg). 2 consecutive readings of hypotension or hypertension will results in withdrawal from the study. Readings of systolic blood pressure from participants who complete the study will be reported in a table showing both systolic and diastolic readings at each time point assessed (Baseline and 4 weeks).
Systolic Blood pressure
Time frame: Mean change from Baseline systolic blood pressure at 8 weeks.
Blood pressure is used to assess hemodynamic stability by measuring the pressure of circulating blood on the walls of blood vessels. Systolic pressure will be assessed during the study period. Reported as: hypotension (less than 90 mmHg), normal blood pressure (90-139 mmHg), or hypertension (140 or greater mmHg). 2 consecutive readings of hypotension or hypertension will results in withdrawal from the study. Readings of systolic blood pressure from participants who complete the study will be reported in a table showing both systolic and diastolic readings at each time point assessed (Baseline and 8 weeks).
Systolic Blood pressure
Time frame: Mean change from 4 weeks systolic blood pressure at 8 weeks.
Blood pressure is used to assess hemodynamic stability by measuring the pressure of circulating blood on the walls of blood vessels. Systolic pressure will be assessed during the study period. Reported as: hypotension (less than 90 mmHg), normal blood pressure (90-139 mmHg), or hypertension (140 or greater mmHg). 2 consecutive readings of hypotension or hypertension will results in withdrawal from the study. Readings of systolic blood pressure from participants who complete the study will be reported in a table showing both systolic and diastolic readings at each time point assessed (4 weeks and 8 weeks).
Diastolic Blood pressure
Time frame: Mean change from Baseline diastolic blood pressure at 4 weeks.
Blood pressure is used to assess hemodynamic stability by measuring the pressure of circulating blood on the walls of blood vessels. Diastolic pressure will be assessed during the study period. Reported as: hypotension (less than 60 mmHg), normal blood pressure (60-89 mmHg), or hypertension (90 or greater mmHg). 2 consecutive readings of hypotension or hypertension will results in withdrawal from the study. Readings of blood pressure from participants who complete the study will be reported in a table showing both systolic and diastolic readings at each time point assessed (Baseline and 4 weeks).
Diastolic Blood pressure
Time frame: Mean change from Baseline diastolic blood pressure at 8 weeks.
Blood pressure is used to assess hemodynamic stability by measuring the pressure of circulating blood on the walls of blood vessels. Diastolic pressure will be assessed during the study period. Reported as: hypotension (less than 60 mmHg), normal blood pressure (60-89 mmHg), or hypertension (90 or greater mmHg). 2 consecutive readings of hypotension or hypertension will results in withdrawal from the study. Readings of blood pressure from participants who complete the study will be reported in a table showing both systolic and diastolic readings at each time point assessed (Baseline and 8 weeks).
Diastolic Blood pressure
Time frame: Mean change from 4 weeks diastolic blood pressure at 8 weeks.
Blood pressure is used to assess hemodynamic stability by measuring the pressure of circulating blood on the walls of blood vessels. Diastolic pressure will be assessed during the study period. Reported as: hypotension (less than 60 mmHg), normal blood pressure (60-89 mmHg), or hypertension (90 or greater mmHg). 2 consecutive readings of hypotension or hypertension will results in withdrawal from the study. Readings of blood pressure from participants who complete the study will be reported in a table showing both systolic and diastolic readings at each time point assessed (4 weeks and 8 weeks).

11 secondary outcomes

Anxiety Subscore Patient Reported Outcomes Measurement Information System 29 (PROMIS-29)
Time frame: Mean change in Baseline Anxiety Score and 8 weeks.
Depression Subscore of the Patient Reported Outcomes Measurement Information System 29 (PROMIS-29)
Time frame: Mean change in Baseline Depression Score and 8 weeks.
Fatigue Subscore of the Patient Reported Outcomes Measurement Information System 29 (PROMIS-29)
Time frame: Mean change in Baseline Fatigue Score and 8 weeks.
Pain Interference Subscore of the Patient Reported Outcomes Measurement Information System 29 (PROMIS-29)
Time frame: Mean change in Baseline Pain Interference Score and 8 weeks.
Sleep Disturbance Subscore of the Patient Reported Outcomes Measurement Information System 29 (PROMIS-29)
Time frame: Mean change in Baseline Sleep Disturbance Score and 8 weeks.
Physical Functioning Subscore of the Patient Reported Outcomes Measurement Information System 29 (PROMIS-29)
Time frame: Mean change in Baseline Physical Functioning Score and 8 weeks.
Social Role Subscore of the Patient Reported Outcomes Measurement Information System 29 (PROMIS-29)
Time frame: Mean change in Baseline Social Role Score and 8 weeks.
Visual Analog Scale (VAS)
Time frame: Mean change in Baseline VAS Score and 4 weeks.
Visual Analog Scale (VAS)
Time frame: Mean change in Baseline VAS Score and 8 weeks.
Visual Analog Scale (VAS)
Time frame: Mean change in 4 weeks VAS Score and 8 weeks.
Patient Reported Outcomes Measurement Information System (PROMIS) Sexual Function Measure
Time frame: Mean change in Baseline PROMIS Sexual Function Score and 8 weeks.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
Background: PubMed 16690671Proctor M, Farquhar C. Diagnosis and management of dysmenorrhoea. BMJ. 2006 May 13;332(7550):1134-8. doi: 10.1136/bmj.332.7550.1134. No abstract available.
Background: PubMed 24695505Osayande AS, Mehulic S. Diagnosis and initial management of dysmenorrhea. Am Fam Physician. 2014 Mar 1;89(5):341-6.
Background: PubMed 20159173Zahradnik HP, Hanjalic-Beck A, Groth K. Nonsteroidal anti-inflammatory drugs and hormonal contraceptives for pain relief from dysmenorrhea: a review. Contraception. 2010 Mar;81(3):185-96. doi: 10.1016/j.contraception.2009.09.014. Epub 2009 Nov 6.
Background: PubMed 11511570Halter F, Tarnawski AS, Schmassmann A, Peskar BM. Cyclooxygenase 2-implications on maintenance of gastric mucosal integrity and ulcer healing: controversial issues and perspectives. Gut. 2001 Sep;49(3):443-53. doi: 10.1136/gut.49.3.443.
Background: PubMed 15829436Lee JH, Cheong J, Park YM, Choi YH. Down-regulation of cyclooxygenase-2 and telomerase activity by beta-lapachone in human prostate carcinoma cells. Pharmacol Res. 2005 Jun;51(6):553-60. doi: 10.1016/j.phrs.2005.02.004.
Background: PubMed 18579323Twardowschy A, Freitas CS, Baggio CH, Mayer B, dos Santos AC, Pizzolatti MG, Zacarias AA, dos Santos EP, Otuki MF, Marques MC. Antiulcerogenic activity of bark extract of Tabebuia avellanedae, Lorentz ex Griseb. J Ethnopharmacol. 2008 Aug 13;118(3):455-9. doi: 10.1016/j.jep.2008.05.013. Epub 2008 May 18.
Background: PubMed 22969019Pereira IT, Burci LM, da Silva LM, Baggio CH, Heller M, Micke GA, Pizzolatti MG, Marques MC, Werner MF. Antiulcer effect of bark extract of Tabebuia avellanedae: activation of cell proliferation in gastric mucosa during the healing process. Phytother Res. 2013 Jul;27(7):1067-73. doi: 10.1002/ptr.4835. Epub 2012 Sep 12.
Background: PubMed 26451712Giacomelli I, Scartoni D, Fiammetta M, Baki M, Zei G, Muntoni C, Cappelli S, Greto D, Scoccianti S, Livi L. Oral Lapacho-Based Medication: An Easy, Safe, and Feasible Support to Prevent and/or Reduce Oral Mucositis During Radiotherapy for Head and Neck Cancer. Nutr Cancer. 2015;67(8):1247-53. doi: 10.1080/01635581.2015.1082114. Epub 2015 Oct 9.
Background: PubMed 22825254Lee MH, Choi HM, Hahm DH, Her E, Yang HI, Yoo MC, Kim KS. Analgesic and anti-inflammatory effects in animal models of an ethanolic extract of Taheebo, the inner bark of Tabebuia avellanedae. Mol Med Rep. 2012 Oct;6(4):791-6. doi: 10.3892/mmr.2012.989. Epub 2012 Jul 17.
Background: PubMed 11574048de Miranda FG, Vilar JC, Alves IA, Cavalcanti SC, Antoniolli AR. Antinociceptive and antiedematogenic properties and acute toxicity of Tabebuia avellanedae Lor. ex Griseb. inner bark aqueous extract. BMC Pharmacol. 2001;1:6. doi: 10.1186/1471-2210-1-6. Epub 2001 Sep 13.
Background: PubMed 18446477Lira AA, Sester EA, Carvalho AL, Strattmann RR, Albuquerque MM, Wanderley AG, Santana DP. Development of lapachol topical formulation: anti-inflammatory study of a selected formulation. AAPS PharmSciTech. 2008;9(1):163-8. doi: 10.1208/s12249-007-9002-z. Epub 2008 Jan 25.
Background: PubMed 2374436de Almeida ER, da Silva Filho AA, dos Santos ER, Lopes CA. Antiinflammatory action of lapachol. J Ethnopharmacol. 1990 May;29(2):239-41. doi: 10.1016/0378-8741(90)90061-w. No abstract available.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ryan Bradley, ND, MPH principal investigator

National University of Natural Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Pau d' Arco in people with Primary Dysmenorrhea, run by National University of Natural Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Red Blood Cell Count (time frame: Mean change in Screening RBC count to 4 weeks.). The study lists 38 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04245540, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.