Effect of Interventions on the Progression of Knee Osteoarthritis (KAPS)

Indus Hospital and Health Network

Status and phase

Completed

Phase 4

Conditions

Osteo Arthritis of the Knees

Treatments

Drug: Diacerien

Drug: Glucosamine/Chondroitin

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02178137

TIH-Ortho-001

Details and patient eligibility

About

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.

Enrollment

322 patients

Sex

All

Ages

40 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

322 participants in 3 patient groups, including a placebo group

Glucosamine/Chondroitin

Active Comparator group

Description:

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.

Treatment:

Drug: Glucosamine/Chondroitin

Diacerien

Active Comparator group

Description:

Diacerien 50 mg twice a day in capsule form. To be taken twice a day after breakfast and dinner

Treatment:

Drug: Diacerien

Placebo pill

Placebo Comparator group

Description:

Placebo tablets with Zinc sulfate twice a day. These will contain pharamacologically non active ingredients (Usually expedients).