Status:
UNKNOWN
China Cimicifuga Trial of Climacteric Complaint Control
Lead Sponsor:
Shandong Luye Pharmaceutical Co., Ltd.
Conditions:
Climacteric Symptoms
Eligibility:
FEMALE
40-60 years
Phase:
PHASE4
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 ph...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2009
Estimated Enrollment :
288 Patients enrolled
Trial Details
Trial ID
NCT00622986
Start Date
February 1 2008
End Date
February 1 2009
Last Update
February 25 2008
Active Locations (13)
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1
Fujian Provincal Maternal and Children Health Hospital
Fuzhou, Fujian, China, 350001
2
The First Affiliated Hospital，SUN YAT-SEN University
Guangzhou, Guangdong, China, 510080
3
Zhongnan University Xiangya No.3. Hospital
Changsha, Hunan, China, 410013
4
Zhongnan University Xiangya No.2. Hospital
Changsha, Hunnan, China, 410011