China Cimicifuga Trial of Climacteric Complaint Control
CCCCC
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
1 other identifier
interventional
288
1 country
13
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2008
Shorter than P25 for phase_4
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 14, 2008
CompletedFirst Posted
Study publicly available on registry
February 25, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedFebruary 25, 2008
February 1, 2008
1 year
February 14, 2008
February 22, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
Change of scores of Kupperman Index before and after the treatment
3 months
Secondary Outcomes (1)
Change of scores of Menopause Rating Scale before and after the treatment
3 months
Study Arms (4)
A1
EXPERIMENTALperimenopausal women
A2
PLACEBO COMPARATORperimenopausal women
B1
EXPERIMENTALearly staged postmenopausal women
B2
PLACEBO COMPARATORearly staged postmenopausal women
Interventions
Each patient will be given the medication of extract of Cimicifuga Foetida L. 2 tablets each day for 3 months.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Fujian Provincal Maternal and Children Health Hospital
Fuzhou, Fujian, 350001, China
The First Affiliated Hospital，SUN YAT-SEN University
Guangzhou, Guangdong, 510080, China
Zhongnan University Xiangya No.3. Hospital
Changsha, Hunan, 410013, China
Zhongnan University Xiangya No.2. Hospital
Changsha, Hunnan, 410011, China
Shandong Provincial Hospital
Jinan, Shandong, 250021, China
The Medical School Hospital Of Qingdao University
Qingdao, Shandong, 266003, China
Bejing Union Hospital
Beijing, 100032, China
The Great Wall Hospital
Beijing, 100853, China
Southwest Hospital
Chongqing, 400038, China
Daping Hospital
Chongqing, 400042, China
Obstetrics & Gynecology Hospital Of Fudan University
Shanghai, 200011, China
International Peace Maternity & Child Health Hospital Of The China Welfare Institute
Shanghai, 200030, China
Tianjin City Hospital for Gynaecology and Obsterics
Tianjin, 300025, China
Study Officials
- STUDY CHAIR
Shouqing Lin, MD
Beijing Union Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 14, 2008
First Posted
February 25, 2008
Study Start
February 1, 2008
Primary Completion
February 1, 2009
Study Completion
February 1, 2009
Last Updated
February 25, 2008
Record last verified: 2008-02