Overview

This trial is active, not recruiting.

Condition osteo arthritis of the knees
Treatments diacerien, glucosamine/chondroitin, placebo
Phase phase 4
Sponsor Indus Hospital
Start date June 2014
End date August 2017
Trial size 322 participants
Trial identifier NCT02178137, TIH-Ortho-001

Summary

There has been intensive search for a substance that can have disease-modifying activity for osteoarthritis. A number of medications have been reported to be of benefit on slowing progression of knee OA. This trial will be the first head to head comparison of these medications.

Patients aged between age 40 to 65 will be enrolled. Patients will be assessed clinically using two scoring systems, the WOMAC index for knee arthritis and the SF 36 for overall physical and mental health. The knee X rays will be assessed on Kellgren and Lawrence grading and will also be measured for joint space narrowing at follow up. The response to arthritis medications on slowing down cartilage loss will be measured biochemically with COMP levels.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Glucosamine/Chondroitin twice a day for a daily total dose of 1500 mg of Glucosamine and 1200 mg of Chondroitin. Tablets will have 750 mg Glucosamine Sulphate and 600 mg of Chondroitin Sulphate. These will be taken twice a day after breakfast and dinner.
glucosamine/chondroitin
(Active Comparator)
Diacerien 50 mg twice a day in capsule form. To be taken twice a day after breakfast and dinner
diacerien Artrodar
(Placebo Comparator)
Placebo tablets with Zinc sulfate twice a day. These will contain pharamacologically non active ingredients (Usually expedients).
placebo Zinc Sulphate

Primary Outcomes

Measure
Change in WOMAC score at 24 months in comparison to baseline score
time frame: baseline, 24 months
Change to the SF-36 score at 24 months in comparison to baseline score
time frame: 24 months
Mean differences in blood serum COMP levels of study arms
time frame: 24 months

Secondary Outcomes

Measure
Change in WOMAC score at 6 months in comparison to baseline score
time frame: 6 months
Change in WOMAC score at 12 months in comparison to baseline score
time frame: 12 months
Change in WOMAC score at 18 months in comparison to baseline score
time frame: 18 months
Change to the SF-36 score at 6 months in comparison to baseline score
time frame: 6 months
Change to the SF-36 score at 12 months in comparison to baseline score
time frame: 12 months
Change to the SF-36 score at 18 months in comparison to baseline score
time frame: 18 months

Eligibility Criteria

Male or female participants from 40 years up to 65 years old.

Inclusion Criteria: - Patients of either sex aged between 40 to 65 years with mild to moderate osteoarthritis of the knees. - Patients should have history of knee pain for at least 6 months and on the majority of days during the preceding month - Each joint will be scored separately so one patient with bilateral knee osteoarthritis will be counted as 2 knees. - The osteoarthritis will be graded on basis of clinical score as well as seen on appropriately positioned x rays using the Kellgren and Lawrence grading. (Tibio femoral osteophytes of at least 1 mm, Kellgren Lawrence grading of 2 or 3) - Patients with diabetes are sent to the diabetes clinic and are included once their HbA1c level becomes normal. - Patients giving Informed consent Exclusion Criteria: - Patients with severe end stage tricompartmental osteoarthritis of the knees . - Presence of uncontrolled systemic disease like chronic liver and renal disease - Patients with diagnosis other than osteoarthritis, such as knee arthritis due to rheumatoid disease, gout, post traumatic arthritis - Patients with history of surgery to any knee will have that knee excluded - Pregnant or lactating mothers - Patients with chronic anaemia - Patients who get an injection in their affected knee

Additional Information

Official title Effect of Interventions on Progression of Knee Osteoarthritis - a Comparison of Effect of Glucosamine/Chondroitin or Diacerin Vs Placebo: Measured by Clinical, Radiological and Biochemical Parameters
Principal investigator Mansoor A Khan, MBBS
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Indus Hospital.