Status:
COMPLETED
Clinical Efficacy of Glucosamine Plus Diacerein Versus Mono-therapy of Glucosamine
Lead Sponsor:
Ramathibodi Hospital
Conditions:
Osteoarthritis
Glucosamine
Eligibility:
All Genders
50+ years
Phase:
PHASE4
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 d...
Eligibility Criteria
Inclusion
- 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
- 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
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT01906801
Start Date
July 1 2013
End Date
October 1 2014
Last Update
May 30 2017
Active Locations (1)
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1
Department of Orthopaedics, Faculty of Medicine Ramathibodi Hospital, Bangkok, Mahidol University
Bangkok, Thailand, 10400