Black Cohosh as Alternative Therapy for Treating Menopause-Related Anxiety

March 1, 2010 updated by: University of Pennsylvania

Black Cohosh Therapy for Menopause-Related Anxiety

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104-3309
        • Depression Research Unit, University of Pennsylvania School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Anxiolytic Therapy
Dietary supplement: Black cohosh

32 to 128 mg (black cohosh)

1 to 4 capsules daily (placebo)
Placebo Comparator: 2
Anxiolytic Therapy
Dietary supplement: Black cohosh

32 to 128 mg (black cohosh)

1 to 4 capsules daily (placebo)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Score on Hamilton Anxiety Rating Scale
Time Frame: 12 Weeks
12 Weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Collaborators

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

Investigators

  • Principal Investigator: Jay D. Amsterdam, MD, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

July 14, 2005

First Submitted That Met QC Criteria

July 14, 2005

First Posted (Estimate)

July 18, 2005

Study Record Updates

Last Update Posted (Estimate)

March 2, 2010

Last Update Submitted That Met QC Criteria

March 1, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R21AT002289-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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