China Cimicifuga Trial of Climacteric Complaint Control
NCT ID: NCT00622986
Last Updated: 2008-02-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
288 participants
INTERVENTIONAL
2008-02-29
2009-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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A1
perimenopausal women
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.
A2
perimenopausal women
placebo
Each patient will be given placebo of 2 tablets each day for 3 months.
B1
early staged postmenopausal women
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.
B2
early staged postmenopausal women
placebo
Each patient will be given placebo of 2 tablets each day for 3 months.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
40 Years
60 Years
FEMALE
No
Sponsors
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Shandong Luye Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Beijing Union Hospital
Principal Investigators
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Shouqing Lin, MD
Role: STUDY_CHAIR
Beijing Union Hospital
Locations
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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
Obstetrics & Gynecology Hospital Of Fudan University
Shanghai, , China
International Peace Maternity & Child Health Hospital Of The China Welfare Institute
Shanghai, , China
Tianjin City Hospital for Gynaecology and Obsterics
Tianjin, , China
Countries
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Central Contacts
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Facility Contacts
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Liping Feng, MD
Role: backup
Min Xue, MD
Role: primary
Fengzhi Liu, MD
Role: primary
Wensheng Fan, MD
Role: backup
Other Identifiers
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XMT-5Cs-002-2007
Identifier Type: -
Identifier Source: org_study_id
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