Black Cohosh Extract for the Management of Moderate to Severe Menopausal Symptoms in Thai Women

December 24, 2011 updated by: Mahidol University

Cimicifuga Racemosa Rhizome and Root Extract for the Management of Moderate to Severe Menopausal Symptoms in Thai Women: a Randomized Controlled Trial

Cimicifuga racemosa (black cohosh) rhizome and root extract have been used to treat menopausal symptoms. To date, there are still scarce information about its efficacy in Thai women with menopausal symptoms. The purpose of this study will assess the efficacy of black cohosh extract in management of menopausal symptoms in Thai women.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

54

Phase

  • Phase 3

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 Locations

  • Thailand
    • Bangkok
      • Bangkoknoi, Bangkok, Thailand, 10700
        • Recruiting
        • Gynecologic Endocrinology Unit, Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University
        • Sub-Investigator:
          • Prasong Tanmahasamut, 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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Thai women, aged ≥ 40 years
  • Peri- or postmenopause
  • Moderate to severe menopausal symptoms from Kupperman menopausal index score at least 20

Exclusion Criteria:

  • Using any drugs or hormonal treatment within 1 month before enrollment
  • BMI ≥ 30 kg/m2
  • Allergic to drugs or any ingredient
  • Liver disease or AST ≥ 37 U/L or ALT ≥ 40 U/L or total bilirubin ≥ 1 mg/dL or direct bilirubin ≥ 0.3 mg/dL
  • Psychiatric disease
  • Alcohol consumption or any elicit drug use
  • Vegetarian (may consume more phytoestrogen)

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
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cimicifuga racemosa
patients receive cimicifuga racemosa rhizome and root extract 40 mg/day (equivalent to triterpene glycosides 12.3 mg)
Drug: cimicifuga racemosa
Cimicifuga racemosa (black cohosh) rhizome and root extract 40 mg once daily for 12 weeks (equivalent to triterpene glycosides 12.3 mg)
PLACEBO_COMPARATOR: Placebo
Placebo containing no active ingredient which match the drug in bottle, shape, color and smell
Drug: placebo
matching placebo without active ingredient 1 tab daily for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean differences of Kupperman index
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adverse events
Time Frame: 12 weeks
12 weeks
Frequencies of menopausal symptoms
Time Frame: 12 weeks
12 weeks
Compliance
Time Frame: 12 weeks
12 weeks
Mean differences of liver function test
Time Frame: 12 weeks
12 weeks
quality of life
Time Frame: 12 weeks
Thai MENQOL measurement
12 weeks
Overall satisfaction
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

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

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Patsama Vichinsartvichai, MD, Gynecologic Endocrinology Unit, Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University

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

December 1, 2011

Primary Completion (ANTICIPATED)

October 1, 2012

Study Completion (ANTICIPATED)

October 1, 2012

Study Registration Dates

First Submitted

December 5, 2011

First Submitted That Met QC Criteria

December 5, 2011

First Posted (ESTIMATE)

December 7, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

December 29, 2011

Last Update Submitted That Met QC Criteria

December 24, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Si573/2011

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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