The efficacy and safety of diacerein versus placebo in the treatment of chronic low back pain. Double-blind, randomized, placebo controlled trial
Phase 4
- Conditions
- Chronic low back painChronic low back pain, Lumbar spondylosis
- Registration Number
- TCTR20210203004
- Lead Sponsor
- Department of Orthopedics, Chiangmai University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Enrolling by invitation
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
the outpatients who had low back pain more than 12 weeks
Exclusion Criteria
Hypersensitivity to diacerein, to similar compounds, NSAIDs or to acetaminophen.
Serious concomitant medical illness
Prior spinal surgery
Epidural steroid injection or facet block within 2 months
Glucosamine or chondroitin sulfate within 4 months
Antidepressant or tranquilizer drugs treatment
Inflammatory joint disease (AS, spondyloarthropathy)
GI disease (diarrhea symptoms)
Laxative drug therapy
Hepatic disease (AST or ALT >=2.5 times)
History of malignancy
Coronary heart disease
Chronic kidney disease
Upper gastrointestinal hemorrhage
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method VAS 1, 4, 7 months mm
- Secondary Outcome Measures
Name Time Method Oswestry Low Back Pain Disability Score 1, 4, 7 months Score,SF-36 score 1, 4, 7 months Score,Adverse events 1, 4, 7 months Frequency