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Trial registered on ANZCTR


Registration number
ACTRN12608000617369
Ethics application status
Approved
Date submitted
2/10/2008
Date registered
8/12/2008
Date last updated
9/12/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Complementary and Alternative Medicine and the menopausal transition: The effect of a Chinese Herbal Formula on Vasomotor symptoms and bone turnover.
Scientific title
A randomised placebo controlled double blind clinical trial on the effectiveness of a herbal formula to alleviate menopausal vasomotor symptoms.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Menopause 3784 0
Condition category
Condition code
Alternative and Complementary Medicine 3959 3959 0 0
Herbal remedies
Reproductive Health and Childbirth 3960 3960 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Herbal medicine formulation in tablet form, with a dosage of 2 tablets twice per day for 16 weeks. The ingredients of the formulation remain commercial-in-confidence.
Intervention code [1] 3500 0
Treatment: Drugs
Comparator / control treatment
Placebo oral tablets designed to look, smell and taste similar to the herbal treatment. Dosage of 2 tablets twice per day for 16 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 4864 0
Reduction in the number and severity of vasomotor symptoms as recorded on the Daily Flush Diary.
Timepoint [1] 4864 0
Daily for 20 weeks.
Secondary outcome [1] 8207 0
Improvement in menopause related quality of life as measured by the Greene Climac Scale.
Timepoint [1] 8207 0
Baseline, weeks 4, 8, 12, 16, 20, 32.
Secondary outcome [2] 8208 0
Improvement in the Hot Flush Related Daily Interference Scale (HFRDI).
Timepoint [2] 8208 0
Baseline, weeks 4, 8, 12, 16, 20, 32.

Eligibility
Key inclusion criteria
1. Women with at least 12 months amenorrhoea aged between 45-65 years.
2. On average 6 episodes of vasomotor symptoms per day.
Minimum age
45 Years
Maximum age
65 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Undiagnosed vaginal bleeding
2. History of breast cancer or cancer
3. Use of corticosteroids or anticoagulants
4. Uncontrolled and/or diagnosed medication conditions likely to interfere with the study treatment

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be screened to ensure they meet the inclusion and exclusion criteria and they must also be in satisfactory health. This will be determined by physical examination and medical history, normal full blood count, liver and kidney function results. Eligible participants will then be enrolled and randomly allocated to either the active or placebo group. Medication randomisation is conducted by a computer at a central administration site where the trial medications are also labelled in numbered (coded) containers to maintain concealment for researchers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised to treatment using a randomly permuted block design generated by computer and performed by a third party.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3968 0
Commercial sector/Industry
Name [1] 3968 0
Global Therapeutics Pty Ltd
Address [1] 3968 0
PO Box 1999
Byron Bay
NSW 2481
Country [1] 3968 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Global Therapeutics Pty Ltd
Address
PO Box 1999
Byron Bay
NSW 2481
Country
Australia
Secondary sponsor category [1] 3558 0
University
Name [1] 3558 0
University of Western Sydney
Address [1] 3558 0
Locked Bag 1797
Penrith South DC
NSW 1797
Country [1] 3558 0
Australia
Other collaborator category [1] 444 0
Hospital
Name [1] 444 0
Royal North Shore Hospital
Address [1] 444 0
Pacific Highway
St Leonards NSW 2065
Country [1] 444 0
Australia
Other collaborator category [2] 445 0
Hospital
Name [2] 445 0
The Chinese Medicine Clinical Research Centre (CMCRC), Liverpool Hospital
Address [2] 445 0
Cnr Elizabeth & Goulburn St
Liverpool NSW 2170
Country [2] 445 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6043 0
University of Western Sydney Human Research Ethics Committee
Ethics committee address [1] 6043 0
Locked Bag 1797
Penrith South DC
NSW 1797
Ethics committee country [1] 6043 0
Australia
Date submitted for ethics approval [1] 6043 0
Approval date [1] 6043 0
Ethics approval number [1] 6043 0
UWS HREC 04/035
Ethics committee name [2] 6044 0
South Western Sydney Area Health Service
Ethics committee address [2] 6044 0
Locked Bag 7017
Liverpool NSW 1871
Ethics committee country [2] 6044 0
Australia
Date submitted for ethics approval [2] 6044 0
Approval date [2] 6044 0
Ethics approval number [2] 6044 0
04/055

Summary
Brief summary
Some evidence suggests that Chinese & western herbs may help reduce menopausal symptoms. Therefore, this study will investigate the effectiveness of a herbal formula to alleviate menopausal vasomotor symptoms and improve quality of life. The trial will consist of two arms, an intervention and a placebo group, with random assignment of participants. All participants and trial researchers will be blinded to treatment allocation. Preliminary data will also be gathered on the effect of herbal therapy on bone metabolic markers.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28998 0
Address 28998 0
Country 28998 0
Phone 28998 0
Fax 28998 0
Email 28998 0
Contact person for public queries
Name 12155 0
Centre for Complementary Medicine Research (CompleMED)
Address 12155 0
University of Western Sydney
Locked Bag 1797
Penrith South DC
NSW 1797
Country 12155 0
Australia
Phone 12155 0
02 4620 3284
Fax 12155 0
Email 12155 0
complemed@uws.edu.au
Contact person for scientific queries
Name 3083 0
Centre for Complementary Medicine Research (CompleMED)
Address 3083 0
University of Western Sydney
Locked Bag 1797
Penrith South DC
NSW 1797
Country 3083 0
Australia
Phone 3083 0
02 4620 3284
Fax 3083 0
Email 3083 0
complemed@uws.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary