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Black Cohosh as Alternative Therapy for Treating Menopause-Related Anxiety

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00120458
Recruitment Status : Completed
First Posted : July 18, 2005
Last Update Posted : March 2, 2010
National Center for Complementary and Integrative Health (NCCIH)
Office of Dietary Supplements (ODS)
Information provided by:
University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Generalized Anxiety Disorder Menopause Dietary Supplement: Black cohosh Phase 4

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  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Black Cohosh Therapy for Menopause-Related Anxiety
Study Start Date : July 2005
Primary Completion Date : December 2008
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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)

Primary Outcome Measures :
  1. Score on Hamilton Anxiety Rating Scale [ Time Frame: 12 Weeks ]

Secondary Outcome Measures :
  1. Quality of life and functional outcome ratings [ Time Frame: 12 Weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00120458

United States, Pennsylvania
Depression Research Unit, University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, United States, 19104-3309
Sponsors and Collaborators
University of Pennsylvania
National Center for Complementary and Integrative Health (NCCIH)
Office of Dietary Supplements (ODS)
Principal Investigator: Jay D. Amsterdam, MD University of Pennsylvania

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jay D. Amsterdam, M.D., University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00120458     History of Changes
Other Study ID Numbers: R21AT002289-01A1 ( U.S. NIH Grant/Contract )
First Posted: July 18, 2005    Key Record Dates
Last Update Posted: March 2, 2010
Last Verified: March 2010

Keywords provided by University of Pennsylvania:
Black Cohosh
Complementary and Alternative Medicine

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders