Chinese Herbal Medicine for Gynecologic Patients

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Dysmenorrhea

In brief

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.

Key facts

Study ID

NCT06187376

Run by

Icahn School of Medicine at Mount Sinai

People needed

0

Starts

2024-07-01

Expected to finish

2024-07-16

Last updated by the study team

2024-07-23

Who can join

Age: 18 and older, up to 36. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Mount Sinai Faculty Practice Associates — New York, New York, United States

Full record on ClinicalTrials.gov

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