Effect of colchicine in osteoarthritis

Phase 2

• Conditions: Knee osteorathritis.; Arthrosis, unspecified; M 19.9

• Registration Number: IRCT2015071623240N1
• Lead Sponsor: Investigator

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

1. American college of rheumatology (ACR) criteria and radiographic Kellgren & Lawrence criteria for osteoarthritis;
2. Knee osteoarthritis;
3. Non existence of Calcium pyrophosphate dihydrate crystal deposition disease (CPPD) arthritis in other joints;
4. No History of gout and pseudo-gout;
5. No History of inflammatory diseases according to laboratory;
6. Non existence of liver, kidney, cardiovascular diseases, cardiomyopathy, moderate to severe neouropathy, GI problems, fibromyalgia, infection;
7. No History of knee joint replacement;
8. No concurrent use of drug interfering with colchicine;
9. No existence of these laboratory tests:
White blood cells <3500/mm3
Hemoglobin <10 mg/dl
Creatinine >1.3 mg/dl
Amino transferase >45 IU
uric acid >6.5 mg/dl
10. At least 2 months after intra-articular corticosteroids and 3 months after intra-articular hyaluronic acid;
11. Using 2 weeks naproxen;
12. At least 4-6 months after use of glucoseamine, chondroitine sulfate or methylsulfonylmethane (MSM);
13. No contra-indication of colchicine;
14. Co-operation.

Exclusion criteria:
1. No use of drugs according to the study protocol;
2. Severe side effect of colchicine or placebo;
3. Aggravation of knee pain;
4. Using analgesics due to other problems;
5. Knee trauma or any other problems interfering with drug use in knee osteoarthritis;
6. Loss of follow-up.

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Health Assessment. Timepoint: 3rd and 4th Months. Method of measurement: modified health assessment questionnaire (modHAQ).;Knee pain. Timepoint: 3rd and 4th Months. Method of measurement: Visual Analog Scale (VAS).;Functional disability. Timepoint: 3rd and 4th Months. Method of measurement: modified Western Ontario and McMaster Universities arthritis (modified WOMAC) index.