Efficacy and Safety of Prednisolone and Chloroquine Add on Therapy in Osteoarthritis of the Knee

Ardabil University of Medical Sciences

Status and phase: Completed; Phase 4

Conditions: Osteoarthritis of the Knee

Treatments: Drug: Glucosamine and Chondroitin sulfate plus Chloroquine; Drug: Glucosamine,Chondroitin sulfate,Prednisolone,Chloroquine; Drug: Glucosamine and chondroitin sulfate; Drug: glucosamine and chondroitin sulfate plus Prednisolone

Study type: Interventional

Funder types: Other

Identifiers

NCT00805519

870919

Details and patient eligibility

About

This study was conducted to evaluate the efficacy and safety of prednisolone and chloroquine add on therapies to combined glucosamine, chondroitin sulfate in osteoarthritis of the knee which will be done in contrast to combined glucosamine sulfate and chondroitin.

Full description

Fixed dose glucosamine, chondroitin sulfate combination is a treatment to osteoarthritis with some controversy about efficacy. it seems that addition of other agents may improve efficacy and decrease the required dose and cost. common oral corticosteroids such as low dose prednisolone and chloroquine are candidate for such add on therapies. nevertheless, add on therapy may expose the patients to new side effects which should followed and addressed.

In this investigator blinded controlled trial, 240 patients with diagnosed osteoarthritis of knee will be enrolled to the study. the patients will randomly be assigned to one of four groups of G (glucosamine and chondroitin sulfate ), P (Glucosamine and Chondroitin sulfate plus Prednisolone), C (Glucosamine and Chondroitin sulfate plus Chloroquine) and PC (Glucosamine and Chondroitin sulfate plus Prednisolone and Chloroquine). each group will consist 60 patients. the investigator(s) will be blind to the groups and interventions.

Enrollment: 230 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• men and non-pregnant women, age 40-85 years with primary OA of at least one knee.

Exclusion criteria

• secondary arthritis related to systemic inflammatory arthritis (including rheumatoid arthritis, psoriatic arthritis, post-infectious arthritis and metabolic arthritis, traumatic arthritis or surgical joint replacement)corticosteroid use:

  • oral corticosteroid within the previous 14 days
  • intramuscular corticosteroid within 30 days
  • intraarticular corticosteroid into the study knee within 90 days
  • intra-articular corticosteroid into any other joint within 30 days or
  • topical corticosteroid at the site of application within 14 days

• ongoing use of prohibited medication including NSAID, other oral analgesic, muscle relaxant, or low-dose antidepressant for any chronic pain management

• glucosamine or chondroitin within the previous six months

• history of alcohol or drug abuse

• lactation

• concomitant skin disease at the application site

• current application for disability benefits on the basis of knee osteoarthritis; fibromyalgia; other painful or disabling condition affecting the knee

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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230 participants in 4 patient groups

Glucosamine and chondroitin sulfate

Active Comparator group

Description:

in this group patients will receive Glucosamine and chondroitin sulfate oral dietary supplementation

Treatment:

Drug: Glucosamine and chondroitin sulfate

P :glucosa, chondroitin, Prednis

Experimental group

Description:

in this group patients will receive glucosamine and chondroitin sulfate plus Prednisolone oral administration

Treatment:

Drug: glucosamine and chondroitin sulfate plus Prednisolone

Glucosa, Chondroitin, Chloroquine

Experimental group

Description:

in this group pateints will orally receive Glucosamine and Chondroitin sulfate plus Chloroquine.

Treatment:

Drug: Glucosamine and Chondroitin sulfate plus Chloroquine

Glucosa, Chondro, Prednis,Chloroq

Experimental group

Description:

in this group patients will receive Glucosamine and Chondroitin sulfate plus Prednisolone and Chloroquine

Treatment:

Drug: Glucosamine,Chondroitin sulfate,Prednisolone,Chloroquine