China Cimicifuga Trial of Climacteric Complaint Control
- Conditions
- Climacteric Symptoms
- Interventions
- Drug: an extract of Cimicifuga Foetida L.Drug: placebo
- Registration Number
- NCT00622986
- Lead Sponsor
- Shandong Luye Pharmaceutical Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 288
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A1 an extract of Cimicifuga Foetida L. perimenopausal women A2 placebo perimenopausal women B1 an extract of Cimicifuga Foetida L. early staged postmenopausal women B2 placebo early staged postmenopausal women
- Primary Outcome Measures
Name Time Method Change of scores of Kupperman Index before and after the treatment 3 months
- Secondary Outcome Measures
Name Time Method Change of scores of Menopause Rating Scale before and after the treatment 3 months
Trial Locations
- Locations (13)
Fujian Provincal Maternal and Children Health Hospital
🇨🇳Fuzhou, Fujian, China
The First Affiliated Hospital，SUN YAT-SEN University
🇨🇳Guangzhou, Guangdong, China
Zhongnan University Xiangya No.3. Hospital
🇨🇳Changsha, Hunan, China
Zhongnan University Xiangya No.2. Hospital
🇨🇳Changsha, Hunnan, China
Shandong Provincial Hospital
🇨🇳Jinan, Shandong, China
The Medical School Hospital Of Qingdao University
🇨🇳Qingdao, Shandong, China
Bejing Union Hospital
🇨🇳Beijing, China
The Great Wall Hospital
🇨🇳Beijing, China
Southwest Hospital
🇨🇳Chongqing, China
Daping Hospital
🇨🇳Chongqing, China
Scroll for more (3 remaining)Fujian Provincal Maternal and Children Health Hospital🇨🇳Fuzhou, Fujian, ChinaYuan Lin, MDPrincipal Investigator