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Chinese Herbal Medicine for Gynecologic Patients

NCT06187376 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2024-07-23

No results posted yet for this study

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

Interventions

DRUG

Chinese Herbal Medicine (CHM) supplement

Dropper of tincture by mouth for 12 weeks.

DRUG

Placebo

Matching placebo tincture.

Sponsors & Collaborators

Principal Investigators

  • Nicola Tavella · Icahn School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
36 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-31
Primary Completion
2024-07-16
Completion
2024-07-16

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06187376 on ClinicalTrials.gov