Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000619347
Ethics application status
Approved
Date submitted
25/09/2008
Date registered
8/12/2008
Date last updated
9/12/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Chinese herbs in the treatment of laparoscopy diagnosed endometriosis: a controlled study.
Scientific title
A randomised double-blind placebo controlled clinical trial of the use of Chinese herbal medicine in the management of endometriosis.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometriosis 3745 0
Condition category
Condition code
Alternative and Complementary Medicine 3922 3922 0 0
Herbal remedies
Reproductive Health and Childbirth 3923 3923 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Chinese herbal medicine extract in oral capsule form, with a dosage of 4 capsules twice daily for six months. The formulation ingredients remain commercial-in-confidence.
Intervention code [1] 3460 0
Treatment: Drugs
Comparator / control treatment
Placebo prepared in identical oral capsules so that size, colour, taste and smell are indistinguishable. The dosage is 4 capsules twice daily for six months.
Control group
Placebo

Outcomes
Primary outcome [1] 4817 0
Pain ascribed to endometriosis using Visual Analog Scale (VAS) & Primary & Secondary Outcomes Form (PS Form I).
Timepoint [1] 4817 0
Baseline, weeks 4, 8, 12, 16, 20, 24, 36.
Secondary outcome [1] 8136 0
Quality of Life in women with endometriosis using the Short Form Health Survey (SF-36) & Primary & Secondary Outcomes Form (PS Form II).
Timepoint [1] 8136 0
SF36: Baseline, week 20, 24, 36
PS Form II: Baseline, weeks 24, 36.
Secondary outcome [2] 8137 0
Pathological involvement of the disease using the blood CA125 test (serum protein elevated in moderate to severe endometriosis).
Timepoint [2] 8137 0
Screening, 4 & 12 weeks after commencing intervention.
Secondary outcome [3] 8138 0
Potential side effects & relevant blood parameters will be monitored throughout the trial (full blood picture, liver function test, urea & creatinine).
Timepoint [3] 8138 0
Screening, weeks 8 & 16.
Secondary outcome [4] 8139 0
Analgesic usage assessed through the Medication Log Book, maintained by the participant.
Timepoint [4] 8139 0
Weeks 4, 8, 12, 16, 24.

Eligibility
Key inclusion criteria
Diagnosed with endometriosis by laparoscopy with at least one of the following:
1. At least 3 months pain
2. Surgical interventions for endometriosis within the last six months
Minimum age
18 Years
Maximum age
43 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Menopause, pregnancy, liver disease, diabetes, malignancies, hormonal treatment, antidepressant treatment, immunosuppressive therapies/conditions.

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)
All participants will be screened for appropriateness by a medical practitioner. If eligible they will be enrolled in the study and randomly allocated to a treatment 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)
Randomisation will be conducted by computer randomisation software, performed by a neutral researcher who is not involved in the trial.
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
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3923 0
University
Name [1] 3923 0
University of Western Sydney
Country [1] 3923 0
Australia
Funding source category [2] 3924 0
Commercial sector/Industry
Name [2] 3924 0
Soho Industri Pharmaci
Country [2] 3924 0
Indonesia
Primary sponsor type
University
Name
University of Western Sydney
Address
Locked bag 1797
Penrith south DC
NSW 1797
Country
Australia
Secondary sponsor category [1] 3519 0
None
Name [1] 3519 0
Address [1] 3519 0
Country [1] 3519 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5989 0
University of Western Sydney Human Research Ethics Committee
Ethics committee address [1] 5989 0
Ethics committee country [1] 5989 0
Australia
Date submitted for ethics approval [1] 5989 0
Approval date [1] 5989 0
05/08/2004
Ethics approval number [1] 5989 0
HEC02/098

Summary
Brief summary
The study is a randomised, double-blind, multi-centre clinical trial to evaluate the use of Chinese herbal medicine in the management of endometriosis. Formulated Chinese herbs will be assessed against an inert placebo. Trial participants will be randomly allocated to either Chinese herbal medicine or placebo. Neither participants nor researchers/assessors will have knowledge of the allocation.

It is a prospective clinical study in which participants are reviewed monthly for six months, and three month follow up. Stringent methodology includes an objective laparoscopy diagnosis of endometriosis and suitable outcome measures. The study also includes ensuring participants completing the trial and, facilitating consistent data collection and validity.

The trial will be a multi-centre clinical trial with participants recruited and reviewed at several health centres.

This will be the first clinical trial in Australia combining Chinese herbal medicine, an objective diagnosis (laparoscopy) and a strict methodological protocol.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28973 0
Address 28973 0
Country 28973 0
Phone 28973 0
Fax 28973 0
Email 28973 0
Contact person for public queries
Name 12130 0
Centre for Complementary Medicine Research
Address 12130 0
University of Western Sydney
Locked bag 1797
Penrith South DC
NSW 1797
Country 12130 0
Australia
Phone 12130 0
02 4620 3284
Fax 12130 0
Email 12130 0
[email protected]
Contact person for scientific queries
Name 3058 0
Centre for Complementary Medicine Research
Address 3058 0
University of Western Sydney
Locked bag 1797
Penrith South DC
NSW 1797
Country 3058 0
Australia
Phone 3058 0
02 4620 3284
Fax 3058 0
Email 3058 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.