The effects of a herbal combination on menopausal symptomatology

ISRCTN ISRCTN98972974
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

School of Health Sciences
PO Box 71
Bundoora
3083
Australia

Study information

Study designRandomised double blind placebo controlled parallel trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleThe effects of a herbal combination on menopausal symptomatology
Study objectivesDoes 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) studiedMenopause
InterventionSt John's wort (Hypericum perforatum) and Chaste tree/berry (Vitex agnus castus) versus an identical placebo treatment.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)St John's Wort (Hypericum perforatum) and Chaste tree/berry (Vitex agnus-castus)
Primary outcome measureScores on the Greene Climacteric scale and flushing and sweating counts
Secondary outcome measuresScores on the High Definition Imaging (HDI) instrument and Utian Quality of Life Scale
Overall study start date01/09/2003
Completion date01/12/2005

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants103
Total final enrolment93
Key inclusion criteria1. 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 criteria1. 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 enrolment01/09/2003
Date of final enrolment01/12/2005

Locations

Countries of recruitment

  • Australia

Study participating centre

School of Health Sciences
Bundoora
3083
Australia

Sponsor information

RMIT University (Australia)
University/education

School of Health Sciences
GPO Box 2476V
Melbourne, Victoria
3001
Australia

Website http://www.rmit.edu.au
ROR logo "ROR" 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)
Alternative name(s)
Royal Melbourne Institute of Technology, RMIT
Location
Australia

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.