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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hot Flashes

Intervention / Treatment
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* Drug: cimicifuga racemosa
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean differences of Kupperman index |  | 12 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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back cohosh, cimicifuga racemosa, menopausal symptoms, hot flashes, Kupperman index, MENQOL