NCT06187376

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: Female
• Age: 18 Years – 36 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Chinese Herbal Medicine (CHM) supplement	Dropper of tincture by mouth for 12 weeks.
DRUG	Placebo	Matching placebo tincture.

Timeline

• Start date: 2024-07-01
• Primary completion: 2024-07-16
• Completion: 2024-07-16
• First posted: 2024-01-02
• Last updated: 2024-07-23

Locations

1 site across 1 country: United States