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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glucosamine and chondroitin sulfate | Active Comparator | in this group patients will receive Glucosamine and chondroitin sulfate oral dietary supplementation |
|
| P :glucosa, chondroitin, Prednis | Experimental | in this group patients will receive glucosamine and chondroitin sulfate plus Prednisolone oral administration |
|
| Glucosa, Chondroitin, Chloroquine | Experimental | in this group pateints will orally receive Glucosamine and Chondroitin sulfate plus Chloroquine. |
|
| Glucosa, Chondro, Prednis,Chloroq | Experimental | in this group patients will receive Glucosamine and Chondroitin sulfate plus Prednisolone and Chloroquine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glucosamine and chondroitin sulfate | Drug | In this arm fixed dose glucosamine (400 mg) and chondroitin sulfate (500 mg)combination will be administrated to the patients, daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome measures is defined as the change from baseline to final assessment of the study knee in the 3 core continuous variables pain and physical function, assessing using the WOMAC subscales, and patient global assessment (PGA) | Baseline | |
| The primary outcome measures is defined as the change from baseline to final assessment of the study knee in the 3 core continuous variables pain and physical function, assessing using the WOMAC subscales, and patient global assessment (PGA) | the outcome is assessed at 6 weeks after baseline visit | |
| The primary outcome measures is defined as the change from baseline to final assessment of the study knee in the 3 core continuous variables pain and physical function, assessing using the WOMAC subscales, and patient global assessment (PGA) | the outcome is assessed at 12 weeks after baseline visit |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary measure will be changes in stiffness | the outcome is assessed at baseline visit | |
| The secondary measure will be changes in stiffness | the outcome is assessed at 6 weeks after baseline visit |
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Inclusion Criteria:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Shahab Bohlooli, PhD | Pharmacology Dept, Faculty of Medicine, ArdabilUMS | Principal Investigator |
| Marina Jastan, MD | Rheomatology clinic, Faculty of Medicine, ArdabilUMS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ArdabiUMS Clinic of Rheumatology | Ardabil | Ardabil Province | 56197 | Iran |
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| glucosamine and chondroitin sulfate plus Prednisolone | 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 |
|
| Glucosamine and Chondroitin sulfate plus Chloroquine | 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. |
|
| Glucosamine,Chondroitin sulfate,Prednisolone,Chloroquine | 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. |
|
| The secondary measure will be changes in stiffness | the outcome is assessed at 12 weeks after baseline visit |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D005944 | Glucosamine |
| D002809 | Chondroitin Sulfates |
| D011239 | Prednisolone |
| D002738 | Chloroquine |
| ID | Term |
|---|---|
| D006595 | Hexosamines |
| D000606 | Amino Sugars |
| D002241 | Carbohydrates |
| D002807 | Chondroitin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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