None listed
Conditions
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.
Interventions
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.
Sponsors
University of Western Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 43 Years
Healthy volunteers
No
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
Exclusion criteria
Menopause, pregnancy, liver disease, diabetes, malignancies, hormonal treatment, antidepressant treatment, immunosuppressive therapies/conditions.
Outcome results
None listed