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black haw |
American Sloe; stag bush; sweet viburnum |
Clinical Trial: Black Cohosh As Alternative Therapy for Treating Menopause-Related Anxiety
This study is currently recruiting patients.
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Generalized Anxiety Disorder Menopause | Drug: Black cohosh | Phase IV |
MedlinePlus consumer health information
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Black Cohosh Therapy for Menopause-Related Anxiety
Secondary Outcomes: Quality of life and functional outcome ratings after 12 weeks
Expected Total Enrollment: 50
Study start: July 2005; Expected completion: June 2007
Last follow-up: June 2007; Data entry closure: June 2007
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.
Eligibility
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
Location and Contact Information
Maryanne Giampapa, BA 215-662-2835 mgiampap@mail.med.upenn.edu
Pennsylvania
Depression Research Unit, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, 19104-3309, United States; Recruiting
Maryanne Giampapa, BA 215-662-2835 mgiampap@mail.med.upenn.edu
Jay D. Amsterdam, MD, Principal Investigator, University of Pennsylvania
More Information
Record last reviewed: July 2005
Last Updated: July 25, 2005
Record first received: July 15, 2005
ClinicalTrials.gov Identifier: NCT00120458
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-07-26
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