Chinese Herbal Medicine for Gynecologic Patients

NCT06187376 | Withdrawn Phase 2

• 1 other identifier: STUDY-23-01101
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Presence or absence of any adverse events

  Presence or absence of any adverse events related to the study protocol during the time of participation.

  up to 3 months

Secondary Outcomes (1)

• Dysmenorrhea Symptom Interference (DSI) Scale

  up to 3 months

Study Arms (2)

Chinese Herbal Medicine (CHM) herbal tincture

EXPERIMENTAL

Chinese herbal tincture

Drug: Chinese Herbal Medicine (CHM) supplement

Placebo

PLACEBO COMPARATOR

Matching placebo tincture.

Drug: Placebo

Interventions

Chinese Herbal Medicine (CHM) supplement DRUG

Dropper of tincture by mouth for 12 weeks.

Chinese Herbal Medicine (CHM) herbal tincture

Placebo DRUG

Matching placebo tincture.

Placebo

Eligibility Criteria

• Age: 18 Years - 36 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Zenchi, Inc.: collaborator

Study Sites (1)

Mount Sinai Faculty Practice Associates

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Dysmenorrhea

Interventions

Rab geranylgeranyltransferase

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Nicola Tavella

  Icahn School of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: January 2, 2024
• Study Start: July 1, 2024
• Primary Completion: July 16, 2024
• Study Completion: July 16, 2024
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose. To achieve aims in the approved proposal. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in the University's data warehouse but without investigator support other than deposited metadata.

Locations

US (1)