Knee osteoarthritis Osteoarthritis knee, Diacerein, Visual analog scale (VAS), Patient-reported outcome measures (PROMs), Performance-based measures (PBMs).
Conditions
Interventions
To receive 50 mg generic diacerein (Diaceric) orally, twice daily for 6 months.,To receive 50 mg brand diacerein (Artrodar) orally, twice daily for 6 months.
Experimental Drug,Active Comparator Drug
generic diacerein (Diaceric),brand diacerein (Artrodar)
Sponsors
Millimed.Co.Ltd.
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. 50 years of age or more 2. Knee OA according to the criteria of the American College of Rheumatology 3. Radiographic grade I-III by the Kellgren/Lawrence classification 4. Pain score of more than 30 mm on a 100-mm visual analog scale (VAS)
Exclusion criteria
Exclusion criteria: 1. Secondary OA 2. Previous surgery on the same knee or knee surgery planned within the following 6months. 3. Lower limb surgery within the last 6 months. 4. Radiographic grade IV by the Kellgren/Lawrence classification 5. Have been treated with any symptomatic slow-acting drugs for osteoarthritis (SYSADOA) within 6 months prior to study. 6. Have been treated with any intraarticular injection (corticosteroids, hyaluronic acid) for at least 3 months before the study. 7. Severe gastrointestinal disorders. 8. Persistent diarrhea (> 3 stools/24 hours) or laxative use. 9. Serious concomitant medical illness or major co-morbidity precluding aerobic exercise at 50-60%maximum heart rate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual Analogue Scale (VAS) at 6 months after the beginning of intervention Visual Analog Scale (VAS) | — |
Secondary
| Measure | Time frame |
|---|---|
| patient-reported outcome measures (PROMs) at 6 months after the beginning of intervention Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index,patient-reported outcome measures (PROMs) at 6 months after the beginning of intervention Short Form-12 (SF-12),performance-based measures (PBMs) at 6 months after the beginning of intervention time up and go (TUG),performance-based measures (PBMs) at 6 months after the beginning of intervention 5-time sit to stand test (5 x SST),performance-based measures (PBMs) at 6 months after the beginning of intervention 3-min walk test (3-min WT) | — |
Countries
Thailand
Contacts
Public ContactAree Tanavalee
Faculty of Medicine, Chulalongkorn University
Outcome results
None listed