ISRCTN98972974
Completed
Not Applicable
The effects of a herbal combination on menopausal symptomatology
RMIT University (Australia)0 sites103 target enrollmentAugust 17, 2006
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Menopause
- Sponsor
- RMIT University (Australia)
- Enrollment
- 103
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. All participants must be women aged between 40 and 60 years
- •2\. Amenorrhoeic for 12 months or more or at least three months’ amenorrhoea in the past 12 months
- •3\. A minimum of five flushes (including sweating episodes) per 24 hour period
- •4\. A minimum score of 20 on the Greene Climacteric scale
- •5\. Prospective participants are required to obtain a general medical examination from a general practitioner
Exclusion Criteria
- •1\. Women on other concomitant treatment for menopausal symptoms, any formula containing the trial herbs, or any medication known to interact with either herb
- •2\. Women with any major health condition (such as history of epilepsy or seizures
- •3\. Pre\-existing cancer, renal or liver disease, diabetes mellitus requiring treatment, uncontrolled hypertension
- •4\. Bipolar disorder, severe depression, current major psychiatric disorder, history of mania)
- •5\. Substance abuse
- •6\. Medically or surgically induced menopause
- •7\. Spasmodic dysmenorrhoea not associated with Pre\-Menstrual Syndrome (PMS)
- •8\. Undiagnosed vaginal bleeding (in post\-menopausal women)
- •9\. Known photosensitivity
- •10\. Known intolerance to St Johns Wort (Hypericum perforatum) or Chaste tree/berry (Vitex agnus\-castus)
Outcomes
Primary Outcomes
Not specified
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