The effects of a herbal combination on menopausal symptomatology
ISRCTN | ISRCTN98972974 |
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DOI | https://doi.org/10.1186/ISRCTN98972974 |
Secondary identifying numbers | 9/03 |
- Submission date
- 26/06/2006
- Registration date
- 17/08/2006
- Last edited
- 06/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Marc Cohen
Scientific
Scientific
School of Health Sciences
PO Box 71
Bundoora
3083
Australia
Study information
Study design | Randomised double blind placebo controlled parallel trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
Scientific title | The effects of a herbal combination on menopausal symptomatology |
Study objectives | Does this herbal combination have a beneficial effect on the vasomotor and/or psychological symptoms associated with menopause? |
Ethics approval(s) | RMIT Human Research Ethics Committee approval obtained 23 June 2003 (reference: Project 9/03). |
Health condition(s) or problem(s) studied | Menopause |
Intervention | St John's wort (Hypericum perforatum) and Chaste tree/berry (Vitex agnus castus) versus an identical placebo treatment. |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | St John's Wort (Hypericum perforatum) and Chaste tree/berry (Vitex agnus-castus) |
Primary outcome measure | 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 study start date | 01/09/2003 |
Completion date | 01/12/2005 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Female |
Target number of participants | 103 |
Total final enrolment | 93 |
Key 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 |
Key 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 |
Date of first enrolment | 01/09/2003 |
Date of final enrolment | 01/12/2005 |
Locations
Countries of recruitment
- Australia
Study participating centre
School of Health Sciences
Bundoora
3083
Australia
3083
Australia
Sponsor information
RMIT University (Australia)
University/education
University/education
School of Health Sciences
GPO Box 2476V
Melbourne, Victoria
3001
Australia
Website | http://www.rmit.edu.au |
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https://ror.org/04ttjf776 |
Funders
Funder type
University/education
Australian College of Phytotherapy
No information available
Jean Hailes Foundation
No information available
RMIT university
Private sector organisation / Universities (academic only)
Private sector organisation / Universities (academic only)
- Alternative name(s)
- Royal Melbourne Institute of Technology, RMIT
- Location
- Australia
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | post-hoc analysis results | 23/06/2009 | 06/01/2021 | Yes | No |
Editorial Notes
06/01/2021: Publication reference and total final enrolment added.