NCT00622986

China Cimicifuga Trial of Climacteric Complaint Control

A Multicentered RCT Study of the Efficacy and Safety of an Extract of Cimicifuga Foetida L. for the Treatment of Climacteric Symptoms of Chinese Women

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 288 (estimated)
• Sponsor: Shandong Luye Pharmaceutical Co., Ltd. · Industry
• Sex: Female
• Age: 40 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to determine whether an extract of Cimicifuga Foetida L. is safe and efficacious to relieve the climacteric symptoms of Chinese women

Detailed description

Extracts of Cimicifuga Racemosa (black cohosh) have been widely used in North America and Europe for decades for the treatment of menopause related problems, either as nutritional supplements or as pharmaceutical products. Previous clinical trials had shown that an extract of Cimicifuga Foetida L.(Ximingting, Luyepharm), which was standardized to have similar components of an extract of Cimicifuga Racemosa, was safe and efficacious to relieve the climacteric symptoms and signs in Chinese women who were recruited according to criteria categorized by theory of Traditional Chinese Medicine.We are interested to know whether it may have the same efficacy and safety profiles when judged with method and standard commonly accepted in western medicine.

Conditions

• Climacteric Symptoms

Interventions

Type	Name	Description
DRUG	an extract of Cimicifuga Foetida L.	Each patient will be given the medication of extract of Cimicifuga Foetida L. 2 tablets each day for 3 months.
DRUG	an extract of Cimicifuga Foetida L.	Each patient will be given the medication of extract of Cimicifuga Foetida L. 2 tablets each day for 3 months.
DRUG	placebo	Each patient will be given placebo of 2 tablets each day for 3 months.
DRUG	placebo	Each patient will be given placebo of 2 tablets each day for 3 months.

Timeline

• Start date: 2008-02-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2008-02-25
• Last updated: 2008-02-25

Locations

13 sites across 1 country: China