Chinese Herbal Medicine for Gynecologic Patients

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dysmenorrhea
• Intervention / Treatment: Drug: Chinese Herbal Medicine (CHM) supplement; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Nicola Tavella, MPH; Phone Number: (212) 241-3888; Email: nicola.tavella@mssm.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai Faculty Practice Associates
      • Contact: Jenny Tang, MD; Phone Number: 212-241-9393; Email: jianjenny.tang@mssm.edu
      • Principal Investigator: Jenny Tang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chinese Herbal Medicine (CHM) herbal tincture; Chinese herbal tincture	Drug: Chinese Herbal Medicine (CHM) supplement; Dropper of tincture by mouth for 12 weeks.
Placebo Comparator: Placebo; Matching placebo tincture.	Drug: Placebo; Matching placebo tincture.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 3 months

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: Zenchi, Inc.
• Investigators: Study Director: Nicola Tavella, Icahn School of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: December 13, 2023
• First Submitted That Met QC Criteria: December 29, 2023
• First Posted (Actual): January 2, 2024

Study Record Updates

• Last Update Posted (Actual): May 13, 2024
• Last Update Submitted That Met QC Criteria: May 10, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Menstruation Disturbances; Pelvic Pain; Dysmenorrhea
• Other Study ID Numbers: STUDY-23-01101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual participant data collected during the trial, after deidentification.
• IPD Sharing Time Frame: Immediately following publication. No end date.

IPD Sharing 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.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No