drugset / Trial / NCT00010959
Single-Dose Study of Black Cohosh and Red Clover
Phase 1
Completed
30 enrolled
National Center for Complementary and Integrative Health (NCCIH)
National Institute of General Medical Sciences (NIGMS) · collabOffice of Dietary Supplements (ODS) · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This Phase I study will assess the pharmacokinetics of two botanicals, Trifolium pratense (red clover) and Cimicifuga racemosa (black cohosh). Participants will receive a single dose of one botanical preparation. The observation period will be one week. Drug toxicity, absorption, distribution, metabolism and elimination data will be collected, and dosages to be utilized in a Phase II clinical trial will be determined.
Timeline
- Start
- 2001-02
- Primary completion
- —
- Completion
- 2002-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Black Cohosh | Traditional medicine (herbal / TCM) | — | — |
| Subject | CLOVER, RED | Unknown | — | — |
Indications
No indication recorded.