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ISRCTN
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ISRCTN19413357
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ClinicalTrials.gov identifier
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Public title
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A multicentre, randomised, double-blind, placebo-controlled clinical trial to evaluate the use of Chinese herbal medicine in the management of endometriosis: a prospective study
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Scientific title
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Acronym
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Endoherb
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Serial number at source
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HEC 02/098
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Study hypothesis
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The hypothesis is that the formulated Chinese herbal treatment shows no significant difference than a placebo in the management of the symptoms of endometriosis.
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Lay summary
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Ethics approval
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Ethics approval received from the University of Western Sydney's Ethics Committee on the 8th August 2002 (ref: HEC 02/098).
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Study design
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A multicentre, randomised, double-blind, placebo-controlled clinical trial
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Countries of recruitment
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Australia
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Disease/condition/study domain
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Endometriosis
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Participants - inclusion criteria
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1. Women, aged 18 - 43 years
2. Diagnosed with endometriosis by laparoscopy and the severity staged (grade I - IV)
3. At least three months of pain measuring more than 30 mm on visual analogue scale (VAS) scale
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Participants - exclusion criteria
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1. Menopause
2. Pregnancy
3. Liver diseases
4. Suffering from diabetes mellitus
5. Suffering from malignancies
6. Hormonal treatments
7. Anti-depressant treatments
8. Immunosuppressive conditions and treatments
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Anticipated start date
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15/11/2004
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Anticipated end date
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15/11/2005
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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100 participants (50 in each arm)
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Interventions
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A specific Chinese herbal formula (Endoherb) versus placebo.
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Primary outcome measure(s)
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Pain intensity due to endometriosis, measured quantitatively on the VAS and qualitatively as descriptive values.
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Secondary outcome measure(s)
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1. Quality of life using the 36-item Short-Form health survey (SF-36) and a study design health survey tool
2. Serum CA 125 levels
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Sources of funding
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University of Western Sydney (Australia)
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Trial website
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Publications
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Contact name
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Dr
Alex
Liew
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Address
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497 South Road
Ashford
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City/town
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South Australia
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Zip/Postcode
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5035
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Country
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Australia
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Tel
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+61 (0)8 83713711
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Fax
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+61 (0)8 83713711
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Email
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endoherb@tpg.com.au
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Sponsor
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University of Western Sydney (Australia)
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Address
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Centre for Complementary Medicine
Locked Bag 1797
Penrith South DC
New South Wales
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City/town
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Sydney
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Zip/Postcode
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1797
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Country
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Australia
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Date applied
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04/05/2006
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Last edited
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20/09/2007
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Date ISRCTN assigned
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02/06/2006
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