Clinical trial NCT00622986: China Cimicifuga Trial of Climacteric Complaint Control
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Climacteric Symptoms
Lead sponsor: Shandong Luye Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2008-02-25
Enrollment: 288
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of scores of Kupperman Index before and after the treatment
timeFrame: 3 months
Secondary outcomes:
measure: Change of scores of Menopause Rating Scale before and after the treatment
timeFrame: 3 months
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Provincal Maternal and Children Health Hospital
state: Fujian
city: Guangzhou
country: China
facility: The First Affiliated Hospital，SUN YAT-SEN University
state: Guangdong
city: Changsha
country: China
facility: Zhongnan University Xiangya No.3. Hospital
state: Hunan
city: Changsha
country: China
facility: Zhongnan University Xiangya No.2. Hospital
state: Hunnan
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Qingdao
country: China
facility: The Medical School Hospital Of Qingdao University
state: Shandong
city: Beijing
country: China
facility: Bejing Union Hospital
city: Beijing
country: China
facility: The Great Wall Hospital
city: Chongqing
country: China
facility: Southwest Hospital
city: Chongqing
country: China
facility: Daping Hospital
city: Shanghai
country: China
facility: Obstetrics & Gynecology Hospital Of Fudan University
city: Shanghai
country: China
facility: International Peace Maternity & Child Health Hospital Of The China Welfare Institute
city: Tianjin
country: China
facility: Tianjin City Hospital for Gynaecology and Obsterics
Study officials:
affiliation: Beijing Union Hospital
name: Shouqing Lin, MD
role: STUDY_CHAIR
References: