DysmenorrheaPhase 2NCT06187376
Chinese Herbal Medicine for Gynecologic Patients
A Phase 2 study testing Chinese Herbal Medicine (CHM) supplement in people with Dysmenorrhea, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
This is a prospective randomized-controlled trial looking at the safety and acceptability of using Chinese herbal medicine in patients with primary dysmenorrhea. The research team hopes to enroll 100 patients, 50 of whom will be randomized to receive the herbal tincture and 50 who will receive a placebo tincture. Read more about this study
- Who is it for?
- Ages 18 to 36 years, women only
- Conditions the study is for
- Dysmenorrhea
- What is being tested?
- Chinese Herbal Medicine (CHM) supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2024to 16 Jul 2024
- Phase
- Phase 2
- 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 36 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female aged 18-36 are met:
- Self-reported pain or discomfort during menstruation, as indicated by Grade 1 or higher on the verbal multidimensional scoring system
- May experience regular menstrual cycle and period must be <7 days in duration
- May be on birth control
- Must know or can estimate the date of the next cycle/period
- May find blood clots in menstrual blood
Show all 16Show fewer
- Must be in good health (doesn't report any medical conditions asked in the screening questionnaire)
- Following a stable, consistent diet regimen
- Follow a stable, consistent exercise regimen and are willing, for the duration of the study, to not decrease or increase the amount of exercise in their regimen
- Agree to refrain from any lifestyle changes that may affect their menstrual cycle for the duration of the study (for example, getting on or off hormonal birth control, reducing the amount of exercise)
- Follow a stable consistent regimen when using any other interventions, such as massage, chiropractic medicine, or acupuncture; agree not to increase or decrease the number of their other interventions
- Willingness to adhere to the dietary supplement regimen
- Willingness to refrain from any other dietary supplements targeting the menstrual cycle during the study period
- Is able to communicate in English
- Is willing and able to share feedback via REDCap
- Must provide written informed consent (ICF)
Who cannot join
- Do not experience a menstrual cycle
- Cannot estimate the onset of their next menstrual cycle
- Do not experience menstrual pain or cramping
- Follow an extreme diet intervention
- Experienced severe weight loss in the past 3 months prior to study participation
- If currently taking allowed supplements, the dosage needs to remain the same throughout the entirety of the study
Show all 14Show fewer
- Food intolerances/allergies that require an EpiPen
- Known allergic reaction to any of the test product ingredients
- Currently pregnant, want to become pregnant for the duration of the study, or who are breastfeeding
- Previous users of Elix Cycle Balance
- Having more than 3 alcoholic drinks a day
- Have been diagnosed with the following conditions: PCOS, endometriosis, PMDD, adenomyosis, Hashimoto's, anorexia, bulimia, orthorexia, binge eating, any other eating disorder
- Smokers
- Not been on a stable dose of birth control for the past 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai Faculty Practice Associates
New York, New York, 10029
About this study
Official title: Evaluating the Safety and Acceptability of Using Chinese Herbal Medicine in Patients With Primary Dysmenorrhea: A Randomized-controlled Trial
This is a prospective randomized-controlled trial looking at the safety and acceptability of using Chinese herbal medicine in patients with primary dysmenorrhea. The research team hopes to enroll 100 patients, 50 of whom will be randomized to receive the herbal tincture and 50 who will receive a placebo tincture. Patients will be enrolled and using the assigned tincture for twelve weeks. The research team will assess safety as a primary outcome by the presence or absence of adverse events related to study protocol during the period of participation.
- Conditions
- Dysmenorrhea
- Being tested
- Chinese Herbal Medicine (CHM) supplement, Placebo
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese Herbal Medicine (CHM) supplementDrug
Dropper of tincture by mouth for 12 weeks.
PlaceboDrug
Matching placebo tincture.
| Study group | Role | What they receive |
|---|---|---|
| Chinese Herbal Medicine (CHM) herbal tincture | Experimental | Chinese herbal tincture Receives: Drug: Chinese Herbal Medicine (CHM) supplement |
| Placebo | Placebo comparator | Matching placebo tincture. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or absence of any adverse events
Presence or absence of any adverse events related to the study protocol during the time of participation.
Measured: up to 3 months
Secondary outcomes (1)
Dysmenorrhea Symptom Interference (DSI) Scale
Dysmenorrhea Symptom Interference (DSI) Scale: Is a nine-item validated measure of symptoms associated with dysmenorrhea including working ability, location, intensity, and days of pain. Symptoms are ranked from 1 (not at all) to 5 (very much) with regard to their interference with various aspects of their daily function. To generate total scores, the nine-items are averaged, thus total scale scores range from 1-5, with higher scores indicating greater interference of dysmenorrhea symptoms.
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2024
- Study startJul 2024 (estimated)
- Primary completion16 Jul 2024
- Study completion16 Jul 2024
Why it stopped: Study withdrawn due to inability to determine path forward regarding study design between sponsor and institutional staff.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysmenorrheaStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Zenchi, Inc.
- Responsible party
- Principal investigator, Jenny Tang, Icahn School of Medicine at Mount Sinai
- Investigators
- Nicola Tavella, Study director, Icahn School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06187376
- Sponsor's protocol ID
- STUDY-23-01101
- Status last verified
- Jul 2024
- First submitted
- 13 Dec 2023
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Safety and Acceptability of Using Chinese Herbal Medicine in Patients With Primary Dysmenorrhea: A Randomized-controlled Trial
- ClinicalTrials.gov ID
- NCT06187376
- Acronym / sponsor ID
- STUDY-23-01101
- Conditions
- Dysmenorrhea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study withdrawn due to inability to determine path forward regarding study design between sponsor and institutional staff.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Zenchi, Inc.
- Study start
- Jul 2024 (estimated)
- Primary completion
- 16 Jul 2024 (actual)
- Study completion
- 16 Jul 2024 (actual)
- First posted
- 2 Jan 2024 (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 a prospective randomized-controlled trial looking at the safety and acceptability of using Chinese herbal medicine in patients with primary dysmenorrhea. The research team hopes to enroll 100 patients, 50 of whom will be randomized to receive the herbal tincture and 50 who will receive a placebo tincture. Patients will be enrolled and using the assigned tincture for twelve weeks. The research team will assess safety as a primary outcome by the presence or absence of adverse events related to study protocol during the period of participation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chinese Herbal Medicine (CHM) herbal tincture | Experimental | Drug: Chinese Herbal Medicine (CHM) supplementChinese herbal tincture |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo tincture. |
Who may qualify
- Ages
- 18 to 36 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Female aged 18-36 are met:
- Self-reported pain or discomfort during menstruation, as indicated by Grade 1 or higher on the verbal multidimensional scoring system
- May experience regular menstrual cycle and period must be <7 days in duration
- May be on birth control
- Must know or can estimate the date of the next cycle/period
Key exclusion criteria (14 listed)
- Do not experience a menstrual cycle
- Cannot estimate the onset of their next menstrual cycle
- Do not experience menstrual pain or cramping
- Follow an extreme diet intervention
- Experienced severe weight loss in the past 3 months prior to study participation
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 |
|---|---|---|
| Chinese Herbal Medicine (CHM) supplementDropper of tincture by mouth for 12 weeks. | Drug | Chinese Herbal Medicine (CHM) herbal tincture |
| PlaceboMatching placebo tincture. | Drug | Placebo |
Primary outcome
Presence or absence of any adverse events
Time frame: up to 3 months
Presence or absence of any adverse events related to the study protocol during the time of participation.
1 secondary outcome
Dysmenorrhea Symptom Interference (DSI) Scale
Time frame: up to 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
Related trials for Dysmenorrhea
Not yet recruiting
Radiofrequency and Pelvic Floor Exercise for Primary Dysmenorrhea
Primary Dysmenorrhea
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
Not yet recruiting
Ultrasound-Guided Radiofrequency Ablation for Focal Adenomyosis
Adenomyosis, Adenomyoma of Uterus
Active, not recruiting
Mindfulness-Based Education For Women With Polycystic Ovary Syndrome
Polycystic Ovary Syndrome (PCOS), Menstrual Symptoms
Not yet recruiting
The Effect of a Ginger Formula on Menstrual Health vs a Placebo
Painful Menstruation
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.
Nicola Tavella study director
Icahn School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chinese Herbal Medicine (CHM) supplement in people with Dysmenorrhea, run by Icahn School of Medicine at Mount Sinai 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 16 inclusion and 14 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: withdrawn, as of the sponsor's last update on 23 Jul 2024. 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. Some participants in this study may receive a placebo. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Presence or absence of any adverse events (time frame: up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jul 2024.