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

Primary Purpose

Hot Flashes

Status

Unknown status

Phase

Phase 3

Locations

Thailand

Study Type

Interventional

Intervention

cimicifuga racemosa

placebo

About this trial

This is an interventional treatment trial for Hot Flashes focused on measuring back cohosh, cimicifuga racemosa, menopausal symptoms, hot flashes, Kupperman index, MENQOL

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

Gynecologic Endocrinology Unit, Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cimicifuga racemosa

Placebo

Arm Description

patients receive cimicifuga racemosa rhizome and root extract 40 mg/day (equivalent to triterpene glycosides 12.3 mg)

Placebo containing no active ingredient which match the drug in bottle, shape, color and smell

Outcomes

Primary Outcome Measures

Mean differences of Kupperman index

Secondary Outcome Measures

Frequencies of menopausal symptoms

Compliance

adverse events

Mean differences of liver function test

quality of life

Thai MENQOL measurement

Overall satisfaction

Full Information

NCT ID

NCT01487694

First Posted

December 5, 2011

Last Updated

December 24, 2011

Sponsor

Mahidol University

1. Study Identification

Unique Protocol Identification Number

NCT01487694

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2011

Overall Recruitment Status

Unknown status

Study Start Date

December 2011 (undefined)

Primary Completion Date

October 2012 (Anticipated)

Study Completion Date

October 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mahidol University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hot Flashes

Keywords

back cohosh, cimicifuga racemosa, menopausal symptoms, hot flashes, Kupperman index, MENQOL

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cimicifuga racemosa

Arm Type

Experimental

Arm Description

patients receive cimicifuga racemosa rhizome and root extract 40 mg/day (equivalent to triterpene glycosides 12.3 mg)

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo containing no active ingredient which match the drug in bottle, shape, color and smell

Intervention Type

Drug

Intervention Name(s)

cimicifuga racemosa

Intervention Description

Cimicifuga racemosa (black cohosh) rhizome and root extract 40 mg once daily for 12 weeks (equivalent to triterpene glycosides 12.3 mg)

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

matching placebo without active ingredient 1 tab daily for 12 weeks

Primary Outcome Measure Information:

Title

Mean differences of Kupperman index

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Frequencies of menopausal symptoms

Time Frame

12 weeks

Title

Compliance

Time Frame

12 weeks

Title

adverse events

Time Frame

12 weeks

Title

Mean differences of liver function test

Time Frame

12 weeks

Title

quality of life

Description

Thai MENQOL measurement

Time Frame

12 weeks

Title

Overall satisfaction

Time Frame

12 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Patsama Vichinsartvichai, MD

Phone

664194657-8

pat_si109@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Patsama Vichinsartvichai, MD

Organizational Affiliation

Gynecologic Endocrinology Unit, Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Gynecologic Endocrinology Unit, Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University

City

Bangkoknoi

State/Province

Bangkok

ZIP/Postal Code

10700

Country

Thailand

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Prasong Tanmahasamut, MD

First Name & Middle Initial & Last Name & Degree

Patsama Vichinsartvichai, MD

12. IPD Sharing Statement

Learn more about this trial

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

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