China Cimicifuga Trial of Climacteric Complaint Control (CCCCC)

The recruitment status of this study is unknown because the information has not been verified recently.
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

February 14, 2008
February 22, 2008
February 2008
February 2009   (final data collection date for primary outcome measure)
Change of scores of Kupperman Index before and after the treatment [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00622986 on ClinicalTrials.gov Archive Site
Change of scores of Menopause Rating Scale before and after the treatment [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
China Cimicifuga Trial of Climacteric Complaint Control
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

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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Climacteric Symptoms
  • 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
  • Drug: placebo
    Each patient will be given placebo of 2 tablets each day for 3 months.
    Other Name: placebo
  • Experimental: A1
    perimenopausal women
    Intervention: Drug: an extract of Cimicifuga Foetida L.
  • Placebo Comparator: A2
    perimenopausal women
    Intervention: Drug: placebo
  • Experimental: B1
    early staged postmenopausal women
    Intervention: Drug: an extract of Cimicifuga Foetida L.
  • Placebo Comparator: B2
    early staged postmenopausal women
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
288
February 2009
February 2009   (final data collection date for primary outcome measure)

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
Female
40 Years to 60 Years
No
Contact: Shouqing Lin, MD 86-10-88068846 shouqing_lin2003@yahoo.com.cn
China
 
NCT00622986
XMT-5Cs-002-2007
No
Prof. Lin Shouqing, Beijing Union Hospital
Shandong Luye Pharmaceutical Co., Ltd.
Not Provided
Study Chair: Shouqing Lin, MD Beijing Union Hospital
Shandong Luye Pharmaceutical Co., Ltd.
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP