China Cimicifuga Trial of Climacteric Complaint Control

Climacteric Symptoms Clinical Trial

— CCCCC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00622986
• Other study ID #: XMT-5Cs-002-2007
• Status: Recruiting
• Phase: Phase 4
• First received: February 14, 2008
• Last updated: February 22, 2008
• Start date: February 2008
• Est. completion date: February 2009

Study information

• Verified date: February 2008
• Source: Shandong Luye Pharmaceutical Co., Ltd.
• Contact: Shouqing Lin, MD
• Phone: 86-10-88068846
• Email: shouqing_lin2003[@]yahoo.com.cn
• Is FDA regulated: No
• Health authority: China: Ministry of HealthChina: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 288
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 60 Years

Eligibility

Inclusion Criteria:

• Having climacteric symptoms with hot flushes >= 3 time per day

• Score of Kupperman Index at baseline >= 20

• In addition to these criteria, women who had menopause longer than 2 months but less than 12 months, with FSH > 15U/L were enrolled into the perimenopausal group. Women having menopause longer than 12 months but less than 5 years, with FSH >= 40U/L and E2 <= 30pg/ml, were assigned into early staged postmenopausal group.

Exclusion Criteria:

• Having history of hysterectomy

• Having HRT within 6 weeks

• Having other drugs or nutritional supplements of relieving climacteric symptoms within one week

• Having psychological counseling within one week

• Having medical history of estrogen-dependent tumors

• The result of pap smear exam at stage III and above

• Having an uterine leiomyoma lager than 4 cm

• The endometrial thickness lager than 0.5 cm

• Having abnormal cardiac, liver or kidney functions

• Having abnormal thyroid function

• Having hypertension, diabetes and coronary heart diseases that were not under control

• Pregnant or suspected pregnant woman

• Having severe mental disorders that inhibit to understand the research purpose

• Other conditions the investigators believed not suitable for enrollment

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Climacteric Symptoms

Intervention

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.
• 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.
• placebo
Each patient will be given placebo of 2 tablets each day for 3 months.
• placebo
Each patient will be given placebo of 2 tablets each day for 3 months.

Locations

Country	Name	City	State
China	Bejing Union Hospital	Beijing
China	The Great Wall Hospital	Beijing
China	Zhongnan University Xiangya No.2. Hospital	Changsha	Hunnan
China	Zhongnan University Xiangya No.3. Hospital	Changsha	Hunan
China	Daping Hospital	Chongqing
China	Southwest Hospital	Chongqing
China	Fujian Provincal Maternal and Children Health Hospital	Fuzhou	Fujian
China	The First Affiliated Hospital,SUN YAT-SEN University	Guangzhou	Guangdong
China	Shandong Provincial Hospital	Jinan	Shandong
China	The Medical School Hospital Of Qingdao University	Qingdao	Shandong
China	International Peace Maternity & Child Health Hospital Of The China Welfare Institute	Shanghai
China	Obstetrics & Gynecology Hospital Of Fudan University	Shanghai
China	Tianjin City Hospital for Gynaecology and Obsterics	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Luye Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of scores of Kupperman Index before and after the treatment		3 months	No
Secondary	Change of scores of Menopause Rating Scale before and after the treatment		3 months	No