Black Cohosh Extract for the Management of Moderate to Severe Menopausal Symptoms in Thai Women
NCT ID: NCT01487694
Last Updated: 2011-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
54 participants
INTERVENTIONAL
2011-12-31
2012-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Cimicifuga racemosa
patients receive cimicifuga racemosa rhizome and root extract 40 mg/day (equivalent to triterpene glycosides 12.3 mg)
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
Placebo containing no active ingredient which match the drug in bottle, shape, color and smell
placebo
matching placebo without active ingredient 1 tab daily for 12 weeks
Interventions
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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
matching placebo without active ingredient 1 tab daily for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* Peri- or postmenopause
* Moderate to severe menopausal symptoms from Kupperman menopausal index score at least 20
Exclusion Criteria
* 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)
40 Years
FEMALE
Yes
Sponsors
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Mahidol University
OTHER
Responsible Party
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Principal Investigators
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Patsama Vichinsartvichai, MD
Role: PRINCIPAL_INVESTIGATOR
Gynecologic Endocrinology Unit, Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University
Locations
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Gynecologic Endocrinology Unit, Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkoknoi, Bangkok, Thailand
Countries
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Central Contacts
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Other Identifiers
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Si573/2011
Identifier Type: -
Identifier Source: org_study_id