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

NCT01487694 | Unknown Phase 3 DMC

• 1 other identifier: Si573/2011
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Hot Flashes

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Mean differences of Kupperman index

  12 weeks

Secondary Outcomes (6)

• Frequencies of menopausal symptoms

  12 weeks

• Compliance

  12 weeks

• adverse events

  12 weeks

• Mean differences of liver function test

  12 weeks

• quality of life

  12 weeks

Study Arms (2)

Cimicifuga racemosa

EXPERIMENTAL

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

Drug: cimicifuga racemosa

Placebo

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

cimicifuga racemosa DRUG

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

Cimicifuga racemosa

placebo DRUG

matching placebo without active ingredient 1 tab daily for 12 weeks

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

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

Bangkoknoi, Bangkok, 10700, Thailand

RECRUITING

MeSH Terms

Conditions

Hot Flashes

Interventions

black cohosh root extract

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Patsama Vichinsartvichai, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patsama Vichinsartvichai, MD

CONTACT

664194657-8; pat_si109@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2011
• First Posted: December 7, 2011
• Study Start: December 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: December 29, 2011

Record last verified: 2011-12

Locations

TH (1)