Effect of colchicine in osteoarthritis

A randomized controlled trial to evaluate the slow acting symptom modifying effect of colchicine in patients with osteoarthritis of the knee

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT2015071623240N1

Enrollment

Registered

2015-09-21

Start date

2012-03-20

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee osteorathritis. Arthrosis, unspecified

Interventions

Intervention 1: Patients receive full-dose naproxen (maximum 1 g daily, Modava pharmaceutical company) for 2 weeks prior to beginning of the treatment and then they give placebo. Intervention 2: Patie

Placebo

Treatment - Drugs

Patients receive full-dose naproxen (maximum 1 g daily, Modava pharmaceutical company) for 2 weeks prior to beginning of the treatment and then they give placebo.

Patients receive full-dose naproxen (maximum 1 g daily, Modava pharmaceutical company) for 2 weeks prior to beginning of the treatment and then they give colchicine 0.5mg/bid (Modava pharmaceutical co

Eligibility

Sex/Gender

All

Age

35 Years to 75 Years

Inclusion criteria

Inclusion criteria: 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 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

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
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.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Maryam Alsadat Mousavi

Shahid Beheshti University of Medical Sciences

ms.mousavi@sbmu.ac.ir+98 21 4444 5366

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026