Status:
WITHDRAWN
Chinese Herbal Medicine for Gynecologic Patients
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
Zenchi, Inc.
Conditions:
Dysmenorrhea
Eligibility:
FEMALE
18-36 years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Exclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 16 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06187376
Start Date
July 1 2024
End Date
July 16 2024
Last Update
July 23 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Mount Sinai Faculty Practice Associates
New York, New York, United States, 10029