Black Cohosh as Alternative Therapy for Treating Menopaus... | NCT00120458

Studies
Black Cohosh as Alternative Therapy for Treating Menopause-Related Anxiety

NCT00120458

Sponsor

University of Pennsylvania

Status

Completed

Last Update Posted

Mar 2, 2010Estimated

Enrollment

50Estimated

Phase

Phase 4

Conditions

Generalized Anxiety Disorder
Menopause

Interventions

Black cohosh

Countries

United States

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
R21AT002289-01A1	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Mar 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2005

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Jul 14, 2005

First Submission Date that Met QC Criteria

Jul 14, 2005

First Posted Date

Jul 18, 2005Estimated

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

Mar 1, 2010

Last Update Posted Date

Mar 2, 2010Estimated

Name	Class
National Center for Complementary and Integrative Health (NCCIH)	NIH
Office of Dietary Supplements (ODS)	NIH

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

This study will determine the effectiveness of the herb black cohosh for treating menopause-related anxiety symptoms in women.

Study hypotheses: 1) Black cohosh will have a superior anti-anxiety effect compared to placebo. 2) Black cohosh will have a comparable safety profile to that of placebo.

Detailed Description

During menopause, up to 90% of women will experience symptoms of anxiety, such as nervousness, irritability, fatigue, muscle aches, depression, and low libido. Concern over the safety and effectiveness of hormone replacement therapy for relieving these symptoms has caused many women to seek alternative medical treatments. Data suggest that black cohosh has a direct effect on the neurotransmitters and receptors involved in anxiety. This study will determine whether black cohosh can effectively treat anxiety symptoms in menopausal women.

This study will last 12 weeks. Participants will be randomly assigned to receive either black cohosh or placebo daily for the duration of the study. Self-report scales will be used to assess participants' anxiety symptoms and quality of life at the beginning and end of the study.

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Anxiolytic Therapy	Dietary Supplement: Black cohosh
2	Placebo Comparator	Anxiolytic Therapy	Dietary Supplement: Black cohosh

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Black cohosh	Dietary Supplement	32 to 128 mg (black cohosh) 1 to 4 capsules daily (placebo)	1 2

Measure	Description	Time Frame
Score on Hamilton Anxiety Rating Scale		12 Weeks

Measure	Description	Time Frame
Quality of life and functional outcome ratings		12 Weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Currently experiencing menopause or postmenopausal
Have symptoms of menopause-related anxiety

Exclusion Criteria:

Any form of generalized anxiety disorder (GAD) unrelated to menopause
Onset of GAD at least 3 years prior to menopause or at least 5 years after menstruation has stopped
Alcohol or drug dependence within 3 months prior to study entry
Allergy to black cohosh
History of hormone replacement therapy
Current use of vaginal estrogen cream or phytoestrogens
Current use of tranquilizers, antidepressants, or antianxiety therapies
Abnormal uterine bleeding
History of estrogen-dependent cancer
History of endometrial hyperplasia (abnormal increase in cells) or endometrial cancer
Rapidly growing uterine fibroids
Abnormal finding upon gynecological examination that would interfere with the study
Abnormal breast examination or mammogram
Any unstable medical condition

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jay D. Amsterdam, MD	University of Pennsylvania	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Depression Research Unit, University of Pennsylvania School of Medicine		Philadelphia	Pennsylvania	19104-3309	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19745648	Derived	Amsterdam JD, Yao Y, Mao JJ, Soeller I, Rockwell K, Shults J. Randomized, double-blind, placebo-controlled trial of Cimicifuga racemosa (black cohosh) in women with anxiety disorder due to menopause. J Clin Psychopharmacol. 2009 Oct;29(5):478-83. doi: 10.1097/JCP.0b013e3181b2abf2.

ID	Term
D000098647	Generalized Anxiety Disorder
D001008	Anxiety Disorders