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

Hot Flashes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01487694
• Other study ID #: Si573/2011
• Status: Recruiting
• Phase: Phase 3
• First received: December 5, 2011
• Last updated: December 24, 2011
• Start date: December 2011
• Est. completion date: October 2012

Study information

• Verified date: December 2011
• Source: Mahidol University
• Contact: Patsama Vichinsartvichai, MD
• Phone: 664194657-8
• Email: pat_si109[@]hotmail.com
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hot Flashes

Intervention

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
matching placebo without active ingredient 1 tab daily for 12 weeks

Locations

Country	Name	City	State
Thailand	Gynecologic Endocrinology Unit, Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University	Bangkoknoi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean differences of Kupperman index		12 weeks	No
Secondary	Frequencies of menopausal symptoms		12 weeks	No
Secondary	Compliance		12 weeks	No
Secondary	adverse events		12 weeks	Yes
Secondary	Mean differences of liver function test		12 weeks	Yes
Secondary	quality of life	Thai MENQOL measurement	12 weeks	No
Secondary	Overall satisfaction		12 weeks	No