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OpenTrials
Completed

NCT Number: NCT00120458

Black Cohosh as Alternative Therapy for Treating 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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Depression Research Unit, University of Pennsylvania School of Medicine

Philadelphia, Pennsylvania, 19104-3309, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Black cohosh

Dietary Supplement

32 to 128 mg (black cohosh)

1 to 4 capsules daily (placebo)

Primary outcomes

  1. Score on Hamilton Anxiety Rating Scale

    Time frame: 12 Weeks

Secondary outcomes

  1. Quality of life and functional outcome ratings

    Time frame: 12 Weeks

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

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

Registry information

Official study title

Black Cohosh Therapy for Menopause-Related Anxiety

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Jul 18, 2005
Registry last updated
Mar 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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