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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
288

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change of scores of Kupperman Index before and after the treatment
Time Frame: 3 months
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shandong Luye Pharmaceutical Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2008

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2009

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 14, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 25, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 25, 2008

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2008

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2008

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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