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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.
Details
| Lead sponsor | Icahn School of Medicine at Mount Sinai |
|---|---|
| Phase | Phase 2 |
| Status | WITHDRAWN |
| Start date | 2024-07 |
| Completion | 2024-07-16 |
Conditions
- Dysmenorrhea
Interventions
- Chinese Herbal Medicine (CHM) supplement
- Placebo
Primary outcomes
- Presence or absence of any adverse events — up to 3 months
Presence or absence of any adverse events related to the study protocol during the time of participation.
Countries
United States