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China Cimicifuga Trial of Climacteric Complaint Control (CCCCC)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2008 by Shandong Luye Pharmaceutical Co., Ltd..
Recruitment status was:  Recruiting
Sponsor:
Information provided by:
Shandong Luye Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00622986
First received: February 14, 2008
Last updated: February 22, 2008
Last verified: February 2008
  Purpose
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

Condition Intervention Phase
Climacteric Symptoms
Drug: an extract of Cimicifuga Foetida L.
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Shandong Luye Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Change of scores of Kupperman Index before and after the treatment [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change of scores of Menopause Rating Scale before and after the treatment [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 288
Study Start Date: February 2008
Estimated Study Completion Date: February 2009
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A1
perimenopausal women
Drug: 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.
Other Name: Ximingting
Placebo Comparator: A2
perimenopausal women
Drug: placebo
Each patient will be given placebo of 2 tablets each day for 3 months.
Experimental: B1
early staged postmenopausal women
Drug: 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.
Other Name: Ximingting
Placebo Comparator: B2
early staged postmenopausal women
Drug: placebo
Each patient will be given placebo of 2 tablets each day for 3 months.

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

Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00622986

Locations
China, Fujian
Fujian Provincal Maternal and Children Health Hospital
Fuzhou, Fujian, China, 350001
China, Guangdong
The First Affiliated Hospital,SUN YAT-SEN University
Guangzhou, Guangdong, China, 510080
China, Hunan
Zhongnan University Xiangya No.3. Hospital
Changsha, Hunan, China, 410013
China, Hunnan
Zhongnan University Xiangya No.2. Hospital
Changsha, Hunnan, China, 410011
China, Shandong
Shandong Provincial Hospital
Jinan, Shandong, China, 250021
The Medical School Hospital Of Qingdao University
Qingdao, Shandong, China, 266003
China
Bejing Union Hospital
Beijing, China, 100032
The Great Wall Hospital
Beijing, China, 100853
Southwest Hospital
Chongqing, China, 400038
Daping Hospital
Chongqing, China, 400042
Obstetrics & Gynecology Hospital Of Fudan University
Shanghai, China, 200011
International Peace Maternity & Child Health Hospital Of The China Welfare Institute
Shanghai, China, 200030
Tianjin City Hospital for Gynaecology and Obsterics
Tianjin, China, 300025
Sponsors and Collaborators
Shandong Luye Pharmaceutical Co., Ltd.
Investigators
Study Chair: Shouqing Lin, MD Beijing Union Hospital
  More Information

Responsible Party: Prof. Lin Shouqing, Beijing Union Hospital
ClinicalTrials.gov Identifier: NCT00622986     History of Changes
Other Study ID Numbers: XMT-5Cs-002-2007 
Study First Received: February 14, 2008
Last Updated: February 22, 2008
Health Authority: China: Ministry of Health
China: Food and Drug Administration

ClinicalTrials.gov processed this record on December 08, 2016