Osteoarthritis Clinical Trial
Verified date | May 2017 |
Source | Ramathibodi Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to compare pain scores, WOMAC total and subscores, actual and change of joint space width and the rate of gastrointestinal side effects at 4, 8, 12, and 24 weeks between dual-therapy of diacerein and glucosamine versus a mono-therapy of glucosamine in OA patients
Status | Completed |
Enrollment | 148 |
Est. completion date | October 2014 |
Est. primary completion date | October 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility |
Adult patients age 50 years or older who have been diagnosed as primary or secondary
osteoarthritis of the knee base on clinical criteria of American College of Rheumatology Inclusion Criteria: - Clinical diagnosis of primary osteoarthritis - Mild deformity Clinical (having no varus or valgus deformity, no crepitus) ? Physical examination grade 0 assessed by stress test Radiographic assessment (Kellgrane-lawrance type II-III), a minimum baseline medial tibiofemoral JSW of _2 mm. - Willing to participate and provide written informed consent Exclusion Criteria: - Non-secondary osteoarthritis Rheumatoid arthritis, inflammatory arthritis (e.g. SLE, Gout), post traumatic osteoarthritis, those who received intra-articular treatment of the signal joint with any product (corticosteroids in the previous 2 months, or glycosaminoglycans/hyaluronic acid in the previous 6 months) or had undergone joint lavage andarthroscopic procedures in the previous 6 months. - No contraindication of using diacerein and glucosamine - Non-current or ex-users of oral SYSADOA (e.g., glucosamine sulphate, chondroitin sulphate, diacerein, piascledine), anti-depressants, tranquillisers, antacids or antibiotics known hypersensitivity to diacerein, to similar compounds, to the excipients or to paracetamol |
Country | Name | City | State |
---|---|---|---|
Thailand | Department of Orthopaedics, Faculty of Medicine Ramathibodi Hospital, Bangkok, Mahidol University | Bangkok |
Lead Sponsor | Collaborator |
---|---|
Ramathibodi Hospital |
Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | pain visual analog scores | 24 weeks | ||
Secondary | Western Ontario and McMaster Universities Osteoarthritis (WOMAC) scores | 24 weeks | ||
Secondary | actual and change of joint space width | 24 weeks | ||
Secondary | Rate of gastrointestinal side effects | 24 weeks |
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