Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
9/03
Study information
Scientific title
Acronym
Study hypothesis
Does this herbal combination have a beneficial effect on the vasomotor and/or psychological symptoms associated with menopause?
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Menopause
Intervention
St John's wort (Hypericum perforatum) and Chaste tree/berry (Vitex agnus castus) versus an identical placebo treatment.
Intervention type
Drug
Phase
Not Specified
Drug names
St John's Wort (Hypericum perforatum) and Chaste tree/berry (Vitex agnus-castus)
Primary outcome measures
Scores on the Greene Climacteric scale and flushing and sweating counts
Secondary outcome measures
Scores on the High Definition Imaging (HDI) instrument and Utian Quality of Life Scale
Overall trial start date
01/09/2003
Overall trial end date
01/12/2005
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
103
Participant 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
Recruitment start date
01/09/2003
Recruitment end date
01/12/2005
Locations
Countries of recruitment
Australia
Trial participating centre
School of Health Sciences
Bundoora
3083
Australia
Sponsor information
Organisation
RMIT University (Australia)
Sponsor details
School of Health Sciences
GPO Box 2476V
Melbourne
Victoria
3001
Australia
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Australian College of Phytotherapy
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Jean Hailes Foundation
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
RMIT university
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
Australia
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary