Abnormal Uterine BleedingHERBALTREATNCT05406960
Therapeutic Effect of Herbal Infusion on Menometrorrhagia
A study testing Tea infusion in people with Abnormal Uterine Bleeding and Menorrhagia; Postmenopausal, run by Faculty of Medicine, Sousse at 1 site in Tunisia.
Trial summary
This is an interventional, non-randomized, controlled, pilot study that explores a new approach to treat, Abnormal uterine bleeding-menometrorrhagia in women, being candidates for hysterectomy, based on tea infusion consumption of a mixture of two plants. Read more about this study
- Who is it for?
- Ages 30 to 55 years, women only
- Conditions the study is for
- Abnormal Uterine Bleeding, Menorrhagia; Postmenopausal, Metrorrhagia
- What is being tested?
- Tea infusion
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteTunisia
- Study dates
- 10 May 2019to 10 Feb 2021
- Phase
- Interventional
- 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 30 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women failed first-line intervention to stop bleeding and planned for hysterectomy
- Women between (30-50 years)
- Able to understand and provide informed consent to participate in the study.
- Not pregnant or lactating
- Having menstrual period more than 7 days with uterine bleeding at irregular intervals.
Who cannot join
- Participants with at least one of the following criteria will not be included in the trial:
- Chronic disease with long-term treatment (i.e. asthma, cardiovascular disorders..)
- woman taking any standard medications for abnormal uterine bleeding
- Women who have a history of gastrointestinal bleeding or ulcer
- Women who have abnormal kidney function
- Participants with increasing menstrual bleeding during the treatment requires surgical emergency procedures.
Show all 11Show fewer
- Those refusing the instructions or participating in other clinical trials.
- Participant take other herbal treatment
- - Age less than 18 years
- - Healthy Volunteers
- women with ovarian tumours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Therapeutic Effect of Traditional Herbal Tea Infusion on Abnormal Uterine Bleeding- Menometrorrhagia
This is an interventional, non-randomized, controlled, pilot study that explores a new approach to treat, Abnormal uterine bleeding-menometrorrhagia in women, being candidates for hysterectomy, based on tea infusion consumption of a mixture of two plants.
Read the detailed description
Menometrorrhagia is excessive uterine bleeding resulting from a combination of two different conditions, namely menorrhagia, which is heavy bleeding during the menstrual period, and metrorrhagia, when the period lasts more than seven days or when uterine bleeding exists between periods. It is defined as abnormal uterine bleeding (AUB) and it is a worldwide health problem affecting 11 to 13% of the general female population in the reproductive age and increasing up to 24% in women aged 40-50 years. Conventional treatment of menometrorrhagia consists of symptomatic treatment including tranexamic acid and levonorgestrel intrauterine device. If the first-line medication fails to treat women with AUB, surgical treatment such as a hysterectomy could be necessary. However, both medical treatments and surgical procedures have different side effects, including gastrointestinal symptoms, liver disease, obesity, and thromboembolic diseases. Moreover, the hypoestrogenic state of these therapies can also lead to rapid bone demineralization and menopausal symptoms, such as vaginal dryness and hot flushes, having a negative effect on women's quality of life. Thus, because of these serious side effects, it seems logical to investigate other available sources. Such problems may be beyond the scope of herbal treatment.
Mentha pulegium is a perennial plant from the Lamiaceae family, also known as Pennyroyal, and is used in pharmaceutical and agro-alimentary industries. Artemisia abrotanum L, commonly known as Southernwood, is a small bushy shrub with small, feathery, narrow, and grey-green leaves. The genus belongs to the Asteraceae family.
A mixture of these two herbs is known as a strong emmenagogue.
Data collection:
The plants used in this study were collected through an ethnobotanical survey. The data on the plants' studies were collected through an internet search in: Medicinal plants mentioned in Canon www., www. Science Direct, www.pubmed.com. , www. Scopus, www.wiley.com, www. Google scholar, www. web of science, books in phytotherapy
All details with regard to :
- The effect of the treatment on the menstrual cycle
- Menstruation duration
- Adverse effects
- Bleeding intensity measured using Pictorial Blood Assessment Chart during three consecutive menstrual treatments and the three-month follow-up. will be collected from participants by phone
Details about the Follow-up:
Allocated to intervention :
Follow-up (Visit 2): Phone or direct contact after the end of oral administration (day 3) for clinical response evaluation.
Phone or direct contact one week after treatment Follow-up 3: Phone or direct contact after the end of oral administration (day 3) for clinical response evaluation.
Phone or direct contact one week after treatment Follow-up (Visit 4): Phone or direct contact after the end of oral administration (day 3) for clinical response evaluation.
Phone or direct contact one week after treatment VISIT 5 (closing visit)
Statistical Analysis
Data entry and analysis will be performed using ( IBMV SPSS R 20.0). To test for normality and distribution of the variables. A significance level of a p-value of less than 0.05 will be considered Descriptive statistics will be used to examine the characteristics of the study population (means, standard deviation).
Comparison of the biological parameters and scores of PBAC between baseline and the end of treatment will be performed using paired t-test when variables are normally distributed and Wilcoxon signed ranks test, as a non-parametric test when variables are not normally distributed.
Sample size
The sample size will be assessed according to the following formula N = (Zα/2) 2 s2 /d2, where "s" is the standard deviation (SD ).
"d" is the accuracy of the estimate. "Zα/2" is the normal deviate for a two-tailed alternative hypothesis at a level of significance.
- Conditions
- Abnormal Uterine Bleeding, Menorrhagia; Postmenopausal, Metrorrhagia, Hysterectomy, Heavy Menstrual Bleeding
- Being tested
- Tea infusion
- Keywords
- plants, Traditional herbal Medicine, Tisane
- Medical subject headings
- Metrorrhagia, Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tea infusionDietary supplement
Herbal tea infusion will be administrated by the oral route before food
| Study group | Role | What they receive |
|---|---|---|
| Tea infusion | Experimental | The aerial parts of each plant were dried, then, they were powdered in a rotating knife grinder. The herbs were taken as tea infusion by the oral route. the powder of the mixture was added to 100 ml of boiling water and the tea infusion was taken three times a day for three consecutive days and it was repeated for three consecutive months Receives: Dietary Supplement: Tea infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduce the menstrual duration in days
the Pictorial Blood Loss Assessment Chart (PBLAC) the number of bleeding day during menstruation
Measured: 180 days
Reduce the bleeding abundance
bleeding abundance will be measured by the Pictorial Blood Loss Assessment Chart (PBLAC) The total score is calculated by adding up the sum of all scores for the sanitary pads used in the menstrual cycle. : 1 for lightly stained, 5 for moderately soiled, and 20 for completely saturated pads. Clots were given a score of 1 for small and 5 for large clots.
Abnormal PBLAC bleeding score greater than or equal to 100, which correlates with bleeding abundance, defined as greater than 80 mL of menstrual blood loss. Normal bleeding is defined as a score of 75 or less. A score of 0 indicates amenorrhea or the absence of menstruation.
Measured: 180 days
Secondary outcomes (5)
Change From Baseline in Hematocrit (Hct) Concentrations at Treatment Day 90
Hematocrit was measured before treatment and after 90 days at the end of treatment
Measured: 180 days
Change From Baseline in Hemoglobin Concentration at Treatment Day 90
Hemoglobin was measured before treatment and after 90 day A positive value indicates an increase in hemoglobin from baseline at treatment day 90
Measured: 90 days
Change From Baseline in Fibrinogen Concentration at Treatment Day 90
Fibrinogen Concentration was measured before treatment and after 90 day
Measured: 90 days
Change From Baseline in Prothrombin Time at Treatment Day 90
Prothrombin Time was measured before treatment and after 90 day
Measured: 90 days
hange From Baseline in serum Creatinine Time at Treatment Day 90
to detect urinary toxicity. conducted at the start of the trial and after the last infusion consumption days 90
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start10 May 2019
- Primary completion20 Dec 2020
- Study completion10 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Abnormal Uterine BleedingStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The gynecologist who decided if the participant met the selection criteria or not Participants meeting the selection criteria will be included in the study. * Before starting all the included participants underwent a complete physical examination. Written informed consent will be obtained. * The herbal tea infusion will be self-administrated by participants at home. * Participants will receive training on how to make herbal tea infusions at home. * Participants will be interviewed by the investigator of the study: * To complete a quality-of-life questionnaire to determine the impact of the illness on their daily life. * Pictorial Bleeding Assessment Chart (PBAC): The history of the last menstruation period Participants will be asked to perform before starting the treatment : * Complete blood count (CBC) * Prothrombin Time (PT) * Prothrombin ratio (INR) * Fibrinogen (FIB) to detect bleeding disorders * serum Creatinine to detect urinary toxicity
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculty of Medicine, Sousse
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hôpital Universitaire Farhat Hached
- Responsible party
- Principal investigator, Pr. Hedi Khairi, Faculty of Medicine, Sousse
- Investigators
- Hedi Khairi, Pr, Study director, CHU, Farhat Hched Hospital, Faculty of medicine sousse tunisia 4000 Sousse TunisiaLatifa Lassoued, Pr.Ag, Study director, CHU Farhat Hached Hospital, Faculty of medicin Sousse,4000,Sousse,Tunisia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05406960
- Sponsor's protocol ID
- FMSELMI
- Acronym
- HERBALTREAT
- Status last verified
- Jun 2022
- First submitted
- 24 Dec 2021
- Last updated
- 7 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Donnez J, Squifflet J, Donnez O. Minimally invasive gynecologic procedures. Curr Opin Obstet Gynecol. 2011 Aug;23(4):289-95. doi: 10.1097/GCO.0b013e328348a283.
PubMed 21666466Bone, K., and Mills, S. Principles and practice of phytotherapy: Modern Herbal Medicine. Churchill Livingstone.2nd ed. Londo n: Elsevier. 2013; 9780702052972
Istre O, Langebrekke A, Qvigstad E. Changing hysterectomy technique from open abdominal to laparoscopic: new trend in Oslo, Norway. J Minim Invasive Gynecol. 2007 Jan-Feb;14(1):74-7. doi: 10.1016/j.jmig.2006.08.011.
PubMed 17218234Jazani NH, Ghasemnejad-Berenji H, Sadegpoor S. Antibacterial effects of Iranian Mentha pulegium essential oil on isolates of Klebsiella sp. Pak J Biol Sci. 2009 Jan 15;12(2):183-5. doi: 10.3923/pjbs.2009.183.185.
PubMed 19579942Kowalski R, Wawrzykowski J, Zawiślak G.Analysis of essential oils and extracts from Artemisia abrotanum L. and Artemisia dracunculus L. Herba Pol.2007.53: 246-254.
Teri Moser Woo, Marylou Robinson.Pharmaco therapeutics for Advance Practice Nurse Prescribers. Library of Congress. (2016:138-1520.
European Tea Committee (ETC), European Herbal Infusions Association (EHIA).Inventory List of Herbals Considered as Food. 2016 Available at: https://thie-online.eu/files/thie/docs/2019-09-26_PU_THIE_Inventory_List_status_27-06-2019_final.pdf
Sutour S, Bradesi P, Casanova J, Tomi F. Composition and chemical variability of Mentha suaveolens ssp. suaveolens and M. suaveolens ssp. insularis from Corsica. Chem Biodivers. 2010 Apr;7(4):1002-8. doi: 10.1002/cbdv.200900365.
PubMed 20397217Fraser IS, Critchley HO, Munro MG, Broder M. Can we achieve international agreement on terminologies and definitions used to describe abnormalities of menstrual bleeding? Hum Reprod. 2007 Mar;22(3):635-43. doi: 10.1093/humrep/del478. Epub 2007 Jan 4.
PubMed 17204526Oueslati, S, Karray-Bouraoui, N, Attia, H. et al. Physiological and antioxidant responses of Mentha pulegium (Pennyroyal) to salt stress. Acta Physiol Plant 32. 2010.289-296. https://doi.org/10.1007/s11738-009-0406-0
Chopra, R.N, Nayar S.L, Chopra, I.C. Glossary of Indian Medicinal Plant, New Delhi. CSIR.1956 .1-330.
Hoffmann TC, Montori VM, Del Mar C. The connection between evidence-based medicine and shared decision making. JAMA. 2014 Oct 1;312(13):1295-6. doi: 10.1001/jama.2014.10186. No abstract available.
PubMed 25268434Qaraaty M, Kamali SH, Dabaghian FH, Zafarghandi N, Mokaberinejad R, Mobli M, Amin G, Naseri M, Kamalinejad M, Amin M, Ghaseminejad A, HosseiniKhabiri SJ, Talei D. Effect of myrtle fruit syrup on abnormal uterine bleeding: a randomized double-blind, placebo-controlled pilot study. Daru. 2014 Jun 2;22(1):45. doi: 10.1186/2008-2231-22-45.
PubMed 24888316Kang M, Ragan BG, Park JH. Issues in outcomes research: an overview of randomization techniques for clinical trials. J Athl Train. 2008 Apr-Jun;43(2):215-21. doi: 10.4085/1062-6050-43.2.215.
PubMed 18345348
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Therapeutic Effect of Traditional Herbal Tea Infusion on Abnormal Uterine Bleeding- Menometrorrhagia
- ClinicalTrials.gov ID
- NCT05406960
- Acronym / sponsor ID
- HERBALTREAT / FMSELMI
- Conditions
- Abnormal Uterine Bleeding, Menorrhagia; Postmenopausal, Metrorrhagia, Hysterectomy, Heavy Menstrual Bleeding
- Keywords
- plants, Traditional herbal Medicine, Tisane
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Faculty of Medicine, SousseUniversity, hospital or other
- Collaborators
- Centre Hôpital Universitaire Farhat Hached
- Study start
- 10 May 2019 (actual)
- Primary completion
- 20 Dec 2020 (actual)
- Study completion
- 10 Feb 2021 (actual)
- First posted
- 7 Jun 2022 (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.
This is an interventional, non-randomized, controlled, pilot study that explores a new approach to treat, Abnormal uterine bleeding-menometrorrhagia in women, being candidates for hysterectomy, based on tea infusion consumption of a mixture of two plants.
Detailed description
Menometrorrhagia is excessive uterine bleeding resulting from a combination of two different conditions, namely menorrhagia, which is heavy bleeding during the menstrual period, and metrorrhagia, when the period lasts more than seven days or when uterine bleeding exists between periods. It is defined as abnormal uterine bleeding (AUB) and it is a worldwide health problem affecting 11 to 13% of the general female population in the reproductive age and increasing up to 24% in women aged 40-50 years. Conventional treatment of menometrorrhagia consists of symptomatic treatment including tranexamic acid and levonorgestrel intrauterine device. If the first-line medication fails to treat women with AUB, surgical treatment such as a hysterectomy could be necessary. However, both medical treatments and surgical procedures have different side effects, including gastrointestinal symptoms, liver disease, obesity, and thromboembolic diseases. Moreover, the hypoestrogenic state of these therapies can also lead to rapid bone demineralization and menopausal symptoms, such as vaginal dryness and hot flushes, having a negative effect on women's quality of life. Thus, because of these serious side effects, it seems logical to investigate other available sources. Such problems may be beyond the scope of herbal treatment.
Mentha pulegium is a perennial plant from the Lamiaceae family, also known as Pennyroyal, and is used in pharmaceutical and agro-alimentary industries. Artemisia abrotanum L, commonly known as Southernwood, is a small bushy shrub with small, feathery, narrow, and grey-green leaves. The genus belongs to the Asteraceae family.
A mixture of these two herbs is known as a strong emmenagogue.
Data collection:
The plants used in this study were collected through an ethnobotanical survey. The data on the plants' studies were collected through an internet search in: Medicinal plants mentioned in Canon www., www. Science Direct, www.pubmed.com. , www. Scopus, www.wiley.com, www. Google scholar, www. web of science, books in phytotherapy
All details with regard to :
- The effect of the treatment on the menstrual cycle
- Menstruation duration
- Adverse effects
- Bleeding intensity measured using Pictorial Blood Assessment Chart during three consecutive menstrual treatments and the three-month follow-up. will be collected from participants by phone
Details about the Follow-up:
Allocated to intervention :
Follow-up (Visit 2): Phone or direct contact after the end of oral administration (day 3) for clinical response evaluation.
Phone or direct contact one week after treatment Follow-up 3: Phone or direct contact after the end of oral administration (day 3) for clinical response evaluation.
Phone or direct contact one week after treatment Follow-up (Visit 4): Phone or direct contact after the end of oral administration (day 3) for clinical response evaluation.
Phone or direct contact one week after treatment VISIT 5 (closing visit)
Statistical Analysis
Data entry and analysis will be performed using ( IBMV SPSS R 20.0). To test for normality and distribution of the variables. A significance level of a p-value of less than 0.05 will be considered Descriptive statistics will be used to examine the characteristics of the study population (means, standard deviation).
Comparison of the biological parameters and scores of PBAC between baseline and the end of treatment will be performed using paired t-test when variables are normally distributed and Wilcoxon signed ranks test, as a non-parametric test when variables are not normally distributed.
Sample size
The sample size will be assessed according to the following formula N = (Zα/2) 2 s2 /d2, where "s" is the standard deviation (SD ).
"d" is the accuracy of the estimate. "Zα/2" is the normal deviate for a two-tailed alternative hypothesis at a level of significance.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The gynecologist who decided if the participant met the selection criteria or not Participants meeting the selection criteria will be included in the study. * Before starting all the included participants underwent a complete physical examination. Written informed consent will be obtained. * The herbal tea infusion will be self-administrated by participants at home. * Participants will receive training on how to make herbal tea infusions at home. * Participants will be interviewed by the investigator of the study: * To complete a quality-of-life questionnaire to determine the impact of the illness on their daily life. * Pictorial Bleeding Assessment Chart (PBAC): The history of the last menstruation period Participants will be asked to perform before starting the treatment : * Complete blood count (CBC) * Prothrombin Time (PT) * Prothrombin ratio (INR) * Fibrinogen (FIB) to detect bleeding disorders * serum Creatinine to detect urinary toxicity
| Arm | Type | Receives |
|---|---|---|
| Tea infusion | Experimental | Dietary Supplement: Tea infusionThe aerial parts of each plant were dried, then, they were powdered in a rotating knife grinder. The herbs were taken as tea infusion by the oral route. the powder of the mixture was added to 100 ml of boiling water and the tea infusion was taken three times a day for three consecutive days and it was repeated for three consecutive months |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women failed first-line intervention to stop bleeding and planned for hysterectomy
- Women between (30-50 years)
- Able to understand and provide informed consent to participate in the study.
- Not pregnant or lactating
- Having menstrual period more than 7 days with uterine bleeding at irregular intervals.
Key exclusion criteria (11 listed)
- Participants with at least one of the following criteria will not be included in the trial:
- Chronic disease with long-term treatment (i.e. asthma, cardiovascular disorders..)
- woman taking any standard medications for abnormal uterine bleeding
- Women who have a history of gastrointestinal bleeding or ulcer
- Women who have abnormal kidney function
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 |
|---|---|---|
| Tea infusionHerbal tea infusion will be administrated by the oral route before food | Dietary supplement | Tea infusion |
Primary outcome
Reduce the menstrual duration in days
Time frame: 180 days
the Pictorial Blood Loss Assessment Chart (PBLAC) the number of bleeding day during menstruation
Reduce the bleeding abundance
Time frame: 180 days
bleeding abundance will be measured by the Pictorial Blood Loss Assessment Chart (PBLAC) The total score is calculated by adding up the sum of all scores for the sanitary pads used in the menstrual cycle. : 1 for lightly stained, 5 for moderately soiled, and 20 for completely saturated pads. Clots were given a score of 1 for small and 5 for large clots. Abnormal PBLAC bleeding score greater than or equal to 100, which correlates with bleeding abundance, defined as greater than 80 mL of menstrual blood loss. Normal bleeding is defined as a score of 75 or less. A score of 0 indicates amenorrhea or the absence of menstruation.
5 secondary outcomes
Change From Baseline in Hematocrit (Hct) Concentrations at Treatment Day 90
Time frame: 180 days
Change From Baseline in Hemoglobin Concentration at Treatment Day 90
Time frame: 90 days
Change From Baseline in Fibrinogen Concentration at Treatment Day 90
Time frame: 90 days
Change From Baseline in Prothrombin Time at Treatment Day 90
Time frame: 90 days
hange From Baseline in serum Creatinine Time at Treatment Day 90
Time frame: 90 days
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 7 Jun 2022.
- Background: PubMed 21666466Donnez J, Squifflet J, Donnez O. Minimally invasive gynecologic procedures. Curr Opin Obstet Gynecol. 2011 Aug;23(4):289-95. doi: 10.1097/GCO.0b013e328348a283.
- BackgroundBone, K., and Mills, S. Principles and practice of phytotherapy: Modern Herbal Medicine. Churchill Livingstone.2nd ed. Londo n: Elsevier. 2013; 9780702052972
- Background: PubMed 17218234Istre O, Langebrekke A, Qvigstad E. Changing hysterectomy technique from open abdominal to laparoscopic: new trend in Oslo, Norway. J Minim Invasive Gynecol. 2007 Jan-Feb;14(1):74-7. doi: 10.1016/j.jmig.2006.08.011.
- Background: PubMed 19579942Jazani NH, Ghasemnejad-Berenji H, Sadegpoor S. Antibacterial effects of Iranian Mentha pulegium essential oil on isolates of Klebsiella sp. Pak J Biol Sci. 2009 Jan 15;12(2):183-5. doi: 10.3923/pjbs.2009.183.185.
- BackgroundKowalski R, Wawrzykowski J, Zawiślak G.Analysis of essential oils and extracts from Artemisia abrotanum L. and Artemisia dracunculus L. Herba Pol.2007.53: 246-254.
- BackgroundTeri Moser Woo, Marylou Robinson.Pharmaco therapeutics for Advance Practice Nurse Prescribers. Library of Congress. (2016:138-1520.
- BackgroundEuropean Tea Committee (ETC), European Herbal Infusions Association (EHIA).Inventory List of Herbals Considered as Food. 2016 Available at: https://thie-online.eu/files/thie/docs/2019-09-26_PU_THIE_Inventory_List_status_27-06-2019_final.pdf
- Background: PubMed 20397217Sutour S, Bradesi P, Casanova J, Tomi F. Composition and chemical variability of Mentha suaveolens ssp. suaveolens and M. suaveolens ssp. insularis from Corsica. Chem Biodivers. 2010 Apr;7(4):1002-8. doi: 10.1002/cbdv.200900365.
- Background: PubMed 17204526Fraser IS, Critchley HO, Munro MG, Broder M. Can we achieve international agreement on terminologies and definitions used to describe abnormalities of menstrual bleeding? Hum Reprod. 2007 Mar;22(3):635-43. doi: 10.1093/humrep/del478. Epub 2007 Jan 4.
- BackgroundOueslati, S, Karray-Bouraoui, N, Attia, H. et al. Physiological and antioxidant responses of Mentha pulegium (Pennyroyal) to salt stress. Acta Physiol Plant 32. 2010.289-296. https://doi.org/10.1007/s11738-009-0406-0
- BackgroundChopra, R.N, Nayar S.L, Chopra, I.C. Glossary of Indian Medicinal Plant, New Delhi. CSIR.1956 .1-330.
- Background: PubMed 25268434Hoffmann TC, Montori VM, Del Mar C. The connection between evidence-based medicine and shared decision making. JAMA. 2014 Oct 1;312(13):1295-6. doi: 10.1001/jama.2014.10186. 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.
Hedi Khairi, Pr study director
CHU, Farhat Hched Hospital, Faculty of medicine sousse tunisia 4000 Sousse Tunisia
Latifa Lassoued, Pr.Ag study director
CHU Farhat Hached Hospital, Faculty of medicin Sousse,4000,Sousse,Tunisia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tea infusion in people with Abnormal Uterine Bleeding and Menorrhagia; Postmenopausal, run by Faculty of Medicine, Sousse at 1 site in Tunisia.
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 5 inclusion and 11 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 7 Jun 2022. 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 Tunisia. 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.
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?
Reduce the menstrual duration in days (time frame: 180 days). The study lists 2 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 NCT05406960, which also lists 14 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 7 Jun 2022.