Osteoarthritis, Glucosamine, Diacerein
Conditions
Keywords
Osteoarthritis, Glucosamine sulfate, Diacerein, Randomized controlled trial
Brief summary
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
Interventions
DRUGDiacerein
DRUGPlacebo (for Diacerein)
Sugar pill manufactured to mimic Diacerein 50 mg tablet
Sponsors
Ramathibodi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pain visual analog scores | 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Western Ontario and McMaster Universities Osteoarthritis (WOMAC) scores | 24 weeks |
| actual and change of joint space width | 24 weeks |
| Rate of gastrointestinal side effects | 24 weeks |
Countries
Thailand
Outcome results
None listed