Chinese Herbal Medicine for Gynecologic Patients

NCT ID: NCT06187376

Last Updated: 2024-07-23

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-31
• Study Completion Date: 2024-07-16

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Chinese Herbal Medicine (CHM) herbal tincture

Chinese herbal tincture

Group Type: EXPERIMENTAL

Chinese Herbal Medicine (CHM) supplement

Intervention Type: DRUG

Dropper of tincture by mouth for 12 weeks.

Placebo

Matching placebo tincture.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo tincture.

Interventions

Chinese Herbal Medicine (CHM) supplement

Dropper of tincture by mouth for 12 weeks.

Intervention Type: DRUG

Placebo

Matching placebo tincture.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 36 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Zenchi, Inc.

INDUSTRY

Sponsor Role: collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Jenny Tang

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nicola Tavella

Role: STUDY_DIRECTOR

Icahn School of Medicine

Locations

Mount Sinai Faculty Practice Associates

New York, New York, United States

Countries

United States

Other Identifiers

STUDY-23-01101

Identifier Type: -

Identifier Source: org_study_id