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The effects of a herbal combination on menopausal symptomatology
ISRCTN ISRCTN98972974
DOI 10.1186/ISRCTN98972974
ClinicalTrials.gov identifier
EudraCT number
Public title The effects of a herbal combination on menopausal symptomatology
Scientific title
Acronym N/A
Serial number at source 9/03
Study hypothesis Does this herbal combination have a beneficial effect on the vasomotor and/or psychological symptoms associated with menopause?
Lay summary
Ethics approval RMIT Human Research Ethics Committee approval obtained 23 June 2003 (reference: Project 9/03).
Study design Randomised double blind placebo controlled parallel trial
Countries of recruitment Australia
Disease/condition/study domain Menopause
Participants - 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
Participants - 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
Anticipated start date 01/09/2003
Anticipated end date 01/12/2005
Status of trial Completed
Patient information material
Target number of participants 103
Interventions St John's wort (Hypericum perforatum) and Chaste tree/berry (Vitex agnus castus) versus an identical placebo treatment.
Primary outcome measure(s) Scores on the Greene Climacteric scale and flushing and sweating counts
Secondary outcome measure(s) Scores on the High Definition Imaging (HDI) instrument and Utian Quality of Life Scale
Sources of funding 1. Australian College of Phytotherapy
2. Jean Hailes Foundation
3. RMIT university
Trial website
Publications
Contact name Prof  Marc  Cohen
  Address School of Health Sciences
PO Box 71
  City/town Bundoora
  Zip/Postcode 3083
  Country Australia
Sponsor RMIT University (Australia)
  Address School of Health Sciences
GPO Box 2476V
  City/town Melbourne, Victoria
  Zip/Postcode 3001
  Country Australia
  Sponsor website: http://www.rmit.edu.au
Date applied 26/06/2006
Last edited 17/08/2006
Date ISRCTN assigned 17/08/2006
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