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Trial registered on ANZCTR


Registration number
ACTRN12608000630314
Ethics application status
Approved
Date submitted
26/09/2008
Date registered
12/12/2008
Date last updated
12/12/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Chinese herbal medicine for Primary Dysmenorrhea.
Scientific title
A randomised, double-blind, placebo controlled clinical trial of the effectiveness of Chinese herbal medicine in the management of primary dysmenorrhea.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary Dysmenorrhea 3756 0
Condition category
Condition code
Alternative and Complementary Medicine 3935 3935 0 0
Herbal remedies
Reproductive Health and Childbirth 3936 3936 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Chinese herbal medicine extract in an oral powder form. Intervention Group 1 – standard Chinese herbal formula. Intervention Group 2 – Individualised Chinese herbal formula. The dosage is for 10 days per menstrual cycle for three months treatment. Taking 6g/day twice per day mixed with warm water, commencing one week prior to bleeding (between days 20-28 of the cycle) until the third day of the cycle (during menstrual bleeding). The formulation ingredients currently remain commercial-in-confidence.
Intervention code [1] 3468 0
Prevention
Intervention code [2] 3469 0
Treatment: Drugs
Comparator / control treatment
Matched placebo designed to look, taste and smell identical to the active interventions in an oral powder form. The dosage is for 10 days per menstrual cycle for three months treatment. Taking 6g/day twice per day mixed with warm water, commencing one week prior to bleeding (between days 20-28 of the cycle) until the third day of the cycle (during menstrual bleeding).
Control group
Placebo

Outcomes
Primary outcome [1] 4834 0
Menstrual Pain Scale
Timepoint [1] 4834 0
Screening, weeks 4, 8, 12, 16, 20, 24, 28.
Secondary outcome [1] 8151 0
Basal Body Temperature
Timepoint [1] 8151 0
Daily from screening until 28 weeks after screening.
Secondary outcome [2] 8744 0
Menstrual Symptom Diary
Timepoint [2] 8744 0
Screening, weeks 4, 8, 12, 16, 20, 24, 28

Eligibility
Key inclusion criteria
Pain in the lower abdomen in relation to menstruation over at least the last three menstrual cycles.
Minimum age
18 Years
Maximum age
45 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. History of any pelvic organic disorder

2. Taking any form of contraceptive

3. Hypertension, diabetes, hepatic disorder, renal disorder, psychological diagnosis

4. Pregnancy

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)
Potential participants are screened for eligibility; if eligible the participant is enrolled and randomly allocated to one of three groups including standard formula, individualised formula or placebo. 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)
A computerised randomisation list was prepared by an independent researcher not involved in subject assessments.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
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] 3932 0
University
Name [1] 3932 0
University of Western Sydney
Address [1] 3932 0
Locked Bag 1797
Penrith South DC
NSW 1797
Country [1] 3932 0
Australia
Funding source category [2] 3933 0
Commercial sector/Industry
Name [2] 3933 0
Sunten Pharmaceutical Co. Ltd.
Address [2] 3933 0
3F, No 11 Roosevelt Rd
Sec 2 Taipei
Taiwan ROC
Country [2] 3933 0
Taiwan, Province Of China
Primary sponsor type
University
Name
University of Western Sydney
Address
Locked Bag 1797
Penrith South DC
NSW 1797
Country
Australia
Secondary sponsor category [1] 3525 0
None
Name [1] 3525 0
Address [1] 3525 0
Country [1] 3525 0
Other collaborator category [1] 432 0
Hospital
Name [1] 432 0
The Chinese Medicine Clinical Research Centre (CMCRC), Liverpool Hospital
Address [1] 432 0
Cnr Elizabeth & Goulburn St
Liverpool NSW 2170
Country [1] 432 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5996 0
University of Western Sydney Human Research Ethics Committee
Ethics committee address [1] 5996 0
Locked Bag 1797
Penrith South DC
NSW 1797
Ethics committee country [1] 5996 0
Australia
Date submitted for ethics approval [1] 5996 0
Approval date [1] 5996 0
Ethics approval number [1] 5996 0
03/195
Ethics committee name [2] 5997 0
South Western Sydney Area Health Service
Ethics committee address [2] 5997 0
Ethics committee country [2] 5997 0
Australia
Date submitted for ethics approval [2] 5997 0
Approval date [2] 5997 0
Ethics approval number [2] 5997 0
03/099

Summary
Brief summary
This is a randomised, double-blind placebo controlled trial in the use of Chinese herbal medicine in the management of primary dysmenorrhea in Australia. This investigation seeks to establish whether Chinese herbs offer any beneficial effect in the management of this disorder. Dysmenorrhea is a common gynaecological complaint among adolescent girls and women of reproductive age and refers to the occurrence of painful menstrual cramps of lower abdominal origin. This trial will include the assessment of Chinese herbs in standard and individual formulas against placebo.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28980 0
Address 28980 0
Country 28980 0
Phone 28980 0
Fax 28980 0
Email 28980 0
Contact person for public queries
Name 12137 0
Centre for Complementary Medicine Research (CompleMED)
Address 12137 0
University of Western Sydney
Locked Bag 1797
Penrith South DC
NSW 1797
Country 12137 0
Australia
Phone 12137 0
02 9772 6384
Fax 12137 0
Email 12137 0
complemed@uws.edu.au
Contact person for scientific queries
Name 3065 0
Centre for Complementary Medicine Research (CompleMED)
Address 3065 0
University of Western Sydney
Locked Bag 1797
Penrith South DC
NSW 1797
Country 3065 0
Australia
Phone 3065 0
02 9772 6384
Fax 3065 0
Email 3065 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