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

NCT ID: NCT00805519

Last Updated: 2010-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2010-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Osteoarthritis of the Knee

Keywords

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Osteoarthritis of the Knee Glucosamine Chondroitin sulfate Prednisolone Chloroquine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Glucosamine and chondroitin sulfate

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

Group Type ACTIVE_COMPARATOR

Glucosamine and chondroitin sulfate

Intervention Type DRUG

In this arm fixed dose glucosamine (400 mg) and chondroitin sulfate (500 mg)combination will be administrated to the patients, daily.

P :glucosa, chondroitin, Prednis

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

Group Type EXPERIMENTAL

glucosamine and chondroitin sulfate plus Prednisolone

Intervention Type DRUG

In this arm fixed dose glucosamine (400 mg) and chondroitin sulfate (500 mg)combination will be administrated to the patients as baseline therapy, daily. also,the patients will receive Prednisolone 5 mg/day

Glucosa, Chondroitin, Chloroquine

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

Group Type EXPERIMENTAL

Glucosamine and Chondroitin sulfate plus Chloroquine

Intervention Type DRUG

In this arm fixed dose glucosamine (400 mg) and chondroitin sulfate (500 mg)combination will be administrated to the patients as baseline therapy, daily. also,the patients will receive chloroquine 150 mg every two days.

Glucosa, Chondro, Prednis,Chloroq

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

Group Type EXPERIMENTAL

Glucosamine,Chondroitin sulfate,Prednisolone,Chloroquine

Intervention Type DRUG

In this arm fixed dose glucosamine (400 mg) and chondroitin sulfate (500 mg)combination will be administrated to the patients as baseline therapy, daily. also,the patients will receive prednisolone 5 mg/day and chloroquine 150 mg every two days.

Interventions

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Glucosamine and chondroitin sulfate

In this arm fixed dose glucosamine (400 mg) and chondroitin sulfate (500 mg)combination will be administrated to the patients, daily.

Intervention Type DRUG

glucosamine and chondroitin sulfate plus Prednisolone

In this arm fixed dose glucosamine (400 mg) and chondroitin sulfate (500 mg)combination will be administrated to the patients as baseline therapy, daily. also,the patients will receive Prednisolone 5 mg/day

Intervention Type DRUG

Glucosamine and Chondroitin sulfate plus Chloroquine

In this arm fixed dose glucosamine (400 mg) and chondroitin sulfate (500 mg)combination will be administrated to the patients as baseline therapy, daily. also,the patients will receive chloroquine 150 mg every two days.

Intervention Type DRUG

Glucosamine,Chondroitin sulfate,Prednisolone,Chloroquine

In this arm fixed dose glucosamine (400 mg) and chondroitin sulfate (500 mg)combination will be administrated to the patients as baseline therapy, daily. also,the patients will receive prednisolone 5 mg/day and chloroquine 150 mg every two days.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ardabil University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Pharmacology Dept., Faculty of Medicine, ArdabilUMS

Principal Investigators

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Shahab Bohlooli, PhD

Role: PRINCIPAL_INVESTIGATOR

Pharmacology Dept, Faculty of Medicine, ArdabilUMS

Marina Jastan, MD

Role: PRINCIPAL_INVESTIGATOR

Rheomatology clinic, Faculty of Medicine, ArdabilUMS

Locations

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ArdabiUMS Clinic of Rheumatology

Ardabil, Ardabil Province, Iran

Site Status

Countries

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Iran

Other Identifiers

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870919

Identifier Type: -

Identifier Source: org_study_id