Chinese Herbal Medicine for Gynecologic Patients

Dysmenorrhea Clinical Trial

Official title:

Evaluating the Safety and Acceptability of Using Chinese Herbal Medicine in Patients With Primary Dysmenorrhea: A Randomized-controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06187376
• Other study ID #: STUDY-23-01101
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 2024
• Est. completion date: July 2025

Study information

• Verified date: May 2024
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Nicola Tavella, MPH
• Phone: (212) 241-3888
• Email: nicola.tavella[@]mssm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 36 Years

Eligibility

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

Related Conditions & MeSH terms

• Dysmenorrhea

Intervention

Drug:
• Chinese Herbal Medicine (CHM) supplement
Dropper of tincture by mouth for 12 weeks.
• Placebo
Matching placebo tincture.

Locations

Country	Name	City	State
United States	Mount Sinai Faculty Practice Associates	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	Zenchi, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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