China Cimicifuga Trial of Climacteric Complaint Control (CCCCC)

February 22, 2008 updated by: Shandong Luye Pharmaceutical Co., Ltd.

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

288

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100032
        • Recruiting
        • Bejing Union Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shouqing Lin, MD
      • Beijing, China, 100853
        • Recruiting
        • The Great Wall Hospital
        • Contact:
        • Contact:
          • Wensheng Fan, MD
          • Phone Number: 86-10-66937254
        • Principal Investigator:
          • Lei Song, MD
      • Chongqing, China, 400038
        • Recruiting
        • Southwest Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Zhiqing Liang, MD
      • Chongqing, China, 400042
      • Shanghai, China, 200011
        • Recruiting
        • Obstetrics & Gynecology Hospital of Fudan University
        • Contact:
        • Principal Investigator:
          • Congjuan Cheng, MD
      • Shanghai, China, 200030
        • Recruiting
        • International Peace Maternity & Child Health Hospital Of The China Welfare Institute
        • Contact:
        • Principal Investigator:
          • Kun Qi, MD
      • Tianjin, China, 300025
        • Recruiting
        • Tianjin City Hospital for Gynaecology and Obsterics
        • Contact:
        • Principal Investigator:
          • Wanjun Lin, MD
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Recruiting
        • Fujian Provincal Maternal and Children Health Hospital
        • Contact:
        • Principal Investigator:
          • Yuan Lin, MD
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Not yet recruiting
        • The First Affiliated Hospital,Sun Yat-sen University
        • Contact:
          • Shuzhong Yao, MD
          • Phone Number: 8342 86-20-87332200
          • Email: yszlfy@163.com
        • Contact:
          • Liping Feng, MD
          • Phone Number: 8342 86-20-87332200
        • Principal Investigator:
          • Shuzhong Yao, MD
    • Hunan
      • Changsha, Hunan, China, 410013
        • Recruiting
        • Zhongnan University Xiangya No.3. Hospital
        • Contact:
          • Min Xue, MD
          • Phone Number: 86-731-8618040
        • Contact:
        • Principal Investigator:
          • Min Xue, MD
    • Hunnan
      • Changsha, Hunnan, China, 410011
        • Recruiting
        • Zhongnan University Xiangya No.2. Hospital
        • Contact:
          • Fengzhi Liu, MD
          • Phone Number: 86-731-5295219
        • Contact:
        • Principal Investigator:
          • Fengzhi Liu, MD
    • Shandong
      • Jinan, Shandong, China, 250021
        • Recruiting
        • Shandong Provincial Hospital
        • Contact:
        • Principal Investigator:
          • Zhongli Yang, MD
      • Qingdao, Shandong, China, 266003
        • Recruiting
        • The Medical School Hospital Of Qingdao University
        • Contact:
        • Principal Investigator:
          • Shuping Zhao, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Ximingting
Placebo Comparator: B2
early staged postmenopausal women
Drug: placebo
Each patient will be given placebo of 2 tablets each day for 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of scores of Kupperman Index before and after the treatment
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change of scores of Menopause Rating Scale before and after the treatment
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong Luye Pharmaceutical Co., Ltd.

Investigators

  • Study Chair: Shouqing Lin, MD, Beijing Union Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Anticipated)

February 1, 2009

Study Completion (Anticipated)

February 1, 2009

Study Registration Dates

First Submitted

February 14, 2008

First Submitted That Met QC Criteria

February 22, 2008

First Posted (Estimate)

February 25, 2008

Study Record Updates

Last Update Posted (Estimate)

February 25, 2008

Last Update Submitted That Met QC Criteria

February 22, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Other Study ID Numbers

  • XMT-5Cs-002-2007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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