Use of Black Cohosh and Red Clover for the Relief of Menopausal Symptoms

Phase 2 Completed 112 enrolled National Center for Complementary and Integrative Health (NCCIH) Office of Dietary Supplements (ODS) · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

This Phase II study, a follow-up to a Phase I trial in normal volunteers, will determine the efficacy of black cohosh and red clover for the relief of menopausal symptoms. It will also assess the safety of chronic dosing (1 year) by evaluating uterine (endometrial biopsies), breast (mammography), and hematology parameters (CBC and chemistry lab values) at baseline and 1 year.

Timeline

Start: 2003-04
Primary completion: —
Completion: 2006-04

Outcome

Missed primary endpoint

paper Black cohosh and red clover did not significantly reduce the frequency of vasomotor symptoms as compared with placebo. PMID 19609225 ↗

Publications

Geller SE, Shulman LP, van Breemen RB, Banuvar S, Zhou Y, Epstein G, Hedayat S, Nikolic D, Krause EC, Piersen CE, Bolton JL, Pauli GF, Farnsworth NR. Safety and efficacy of black cohosh and red clover for the management of vasomotor symptoms: a randomized controlled trial. Menopause. 2009 Nov-Dec;16(6):1156-66. doi: 10.1097/gme.0b013e3181ace49b.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Black Cohosh	Traditional medicine (herbal / TCM)	—	—
Subject	CLOVER, RED	Unknown	—	—

Indications

No indication recorded.