Condition category
Urological and Genital Diseases
Date applied
26/06/2006
Date assigned
17/08/2006
Last edited
17/08/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Marc Cohen

ORCID ID

Contact details

School of Health Sciences
PO Box 71
Bundoora
3083
Australia

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

http://www.rmit.edu.au

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

Publication citations

Additional files

Editorial Notes