Menopause Urological and Genital Diseases Menopause
Conditions
Interventions
St John's wort (Hypericum perforatum) and Chaste tree/berry (Vitex agnus castus) versus an identical placebo treatment.
Sponsors
RMIT University (Australia)
Eligibility
Sex/Gender
Female
Inclusion 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
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) 11. Pregnancy or attempting to conceive 12. Women participating in another clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Scores on the Greene Climacteric scale and flushing and sweating counts | — |
Secondary
| Measure | Time frame |
|---|---|
| Scores on the High Definition Imaging (HDI) instrument and Utian Quality of Life Scale | — |
Countries
Australia
Outcome results
None listed