The effects of a herbal combination on menopausal symptomatology

ISRCTN	ISRCTN98972974
DOI	https://doi.org/10.1186/ISRCTN98972974
Secondary identifying numbers	9/03

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Marc Cohen
Scientific

School of Health Sciences
PO Box 71
Bundoora
3083
Australia

Study design	Randomised double blind placebo controlled parallel trial
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

Participant type(s)	Patient
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

School of Health Sciences

Bundoora
3083
Australia

RMIT University (Australia)
University/education

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

Website	http://www.rmit.edu.au
"ROR"	https://ror.org/04ttjf776

University/education

Australian College of Phytotherapy

No information available

Jean Hailes Foundation

No information available

RMIT university
Private sector organisation / Universities (academic only)

Intention to publish date
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

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

06/01/2021: Publication reference and total final enrolment added.