Black Cohosh Extract for Treatment of Moderate to Severe... | NCT02093650

Studies
Black Cohosh Extract for Treatment of Moderate to Severe Menopausal Symptoms

NCT02093650

Sponsor

Navamindradhiraj University

Status

Unknown status

Last Update Posted

Sep 25, 2014Estimated

Enrollment

60Estimated

Phase

Phase 3

Conditions

Menopause
Quality of Life

Interventions

black cohosh extract
Placebo

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
TCTR20140318001	Registry Identifier	Thai Clinical Trials Registry

Status Module

Record Verification Date

Sep 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2014

Primary Completion Date

Mar 2016Estimated

Completion Date

Jul 2016Estimated

First Submitted Date

Mar 19, 2014

First Submission Date that Met QC Criteria

Mar 19, 2014

First Posted Date

Mar 21, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 23, 2014

Last Update Posted Date

Sep 25, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Compare the treatment efficacy of black cohosh extract 80 mg daily and placebo for moderate to severe menopausal symptoms

Detailed Description

Compare the treatment efficacy of black cohosh extract 80 mg/day an placebo for moderate to severe menopausal symptoms with Kupperman menopausal index and MENQOL

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Black cohosh extract	Active Comparator	black cohosh extract 80 mg daily	Drug: black cohosh extract
Placebo	Placebo Comparator	Matching placebo	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
black cohosh extract	Drug	Black cohosh extract 80 mg	Black cohosh extract

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The changes in Kupperman Index	Kupperman index questionnaire at baseline, 4, 8 and 12 weeks	baseline, week 4, week 8 and week 12

Secondary Outcomes

Measure	Description	Time Frame
A change in MENQOL	MENQOL questionnaire measurement at baseline and 12 weeks	baseline and week 12
The changes in daily hot flushes frequency	Daily hot flushes frequency over 12 weeks treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age at least 40 years
Peri or post menopause
Moderate to severe menopausal symptoms (Kupperman index at least 20)

Exclusion Criteria:

Use hormonal treatment or other treatments within 4 weeks
Use atorvastatin azathioprine or cyclosporin within 4 weeks
BMI at least 30 kg m2
Allergic to drug or components
Liver disease or abnormal liver function test
Psychiatric disease
Alcoholic or drug abuse
Vegetarian

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Patsama Vichinsartvichai, MD.	Contact	+66877905656		pat_si109@hotmail.com
Lookwai Kutheerawong, MD.	Contact	+66820886464		lookwaik@yahoo.com

Overall Officials

Name	Affiliation	Role
Patsama Vichinsartvichai, MD	Faculty of Medicine Vajira Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Obstetrics and Gynecology, Faculty of Medicine Vajira Hospital, Navamindradhiraj University	Recruiting	Dusit	Bangkok	10300	Thailand

Intervention Browse Module

MeSH Terms

ID	Term
C000713173	black cohosh root extract

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided