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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glucosamine/Chondroitin | 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. |
|
| Diacerien | Active Comparator | Diacerien 50 mg twice a day in capsule form. To be taken twice a day after breakfast and dinner |
|
| Placebo pill | Placebo Comparator | Placebo tablets with Zinc sulfate twice a day. These will contain pharamacologically non active ingredients (Usually expedients). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diacerien | Drug |
|
| |
| Glucosamine/Chondroitin |
| Measure | Description | Time Frame |
|---|---|---|
| Change in WOMAC score at 24 months in comparison to baseline score | Hypothesis:- At least one of the intervention drug will result in an improvement of at least 20 points on the WOMAC score at end of 2 years as compared to the placebo when compared to base line score | baseline, 24 months |
| Change to the SF-36 score at 24 months in comparison to baseline score | Hypothesis: At least one of the intervention drugs will result in an improvement of at least 20 points at end of two years when assessed using the SF36 total score as compared to the standard therapy placebo when compared with baseline score | 24 months |
| Mean differences in blood serum COMP levels of study arms | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in WOMAC score at 6 months in comparison to baseline score | 6 months | |
| Change in WOMAC score at 12 months in comparison to baseline score | 12 months | |
| Change in WOMAC score at 18 months in comparison to baseline score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mansoor A Khan, MBBS | The Indus Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Indus Hospital | Karachi | Sindh | Pakistan |
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| ID | Term |
|---|---|
| C025292 | diacerein |
| D005944 | Glucosamine |
| D002807 | Chondroitin |
| D019287 | Zinc Sulfate |
| ID | Term |
|---|---|
| D006595 | Hexosamines |
| D000606 | Amino Sugars |
| D002241 | Carbohydrates |
| D006025 | Glycosaminoglycans |
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| Drug |
|
| Placebo | Drug |
|
|
| 18 months |
| Change to the SF-36 score at 6 months in comparison to baseline score | 6 months |
| Change to the SF-36 score at 12 months in comparison to baseline score | 12 months |
| Change to the SF-36 score at 18 months in comparison to baseline score | 18 months |
| D011134 |
| Polysaccharides |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D007287 | Inorganic Chemicals |
| D017967 | Zinc Compounds |