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This study aims to evaluate the possible efficacy and safety of nicorandil as anti-inflammatory in managing patients with active rheumatoid arthritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | No Intervention | this group will include 23 patients who will receive their traditional therapy of RA for 3 months. | |
| Nicorandil group | Active Comparator | this group will include 23 patients who will receive 5 mg nicorandil twice daily before meals plus the traditional therapy of RA for 3 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicorandil 5 MG Oral Tablet | Drug | Nicorandil 5 MG Oral Tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| change in 28-joint count Disease Activity Score (DAS28) using C- reactive protein level (CRP) | Calculation of 28-joint count Disease Activity Score (DAS28) using C- reactive protein level (CRP) where: Remission: < 2.6. Low Disease Activity (LDA): ≤ 3.2. Moderate Disease Activity (MDA): 3.2 - 5.1. High Disease Activity (HDA): > 5.1 | 3 months |
| change in Multidimensional Health Assessment Questionnaire (MDHAQ) scores. | Before and 3 months after the intervention, the validated Arabic Multidimensional Health Assessment Questionnaire (MDHAQ) Physical Function: Assessed through 10 activities, scored 0-3 (without difficulty=0, some=1, much=2, unable=3), with higher scores indicating worse function | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| The change in the serum level of 8-hydroxydeoxyguanosine (8-OHdG) at baseline and after 3 months. | Blood samples will be collected at baseline and after 3 months | 3 months |
| The change in the serum level of Interleukin 6 (IL-6) at baseline and after 3 months . |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karim Abu Elfath Hussein | Contact | +201141332986 | Kareem_hussein@pharm.tanta.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta university | Recruiting | Tanta | Gharbia Governorate | Egypt |
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| ID | Term |
|---|---|
| D020108 | Nicorandil |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D009566 | Nitrates |
| D009930 | Organic Chemicals |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
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Blood samples will be collected at baseline and after 3 months |
| 3 months |
| The change in the serum level of C- reactive protein (CRP) at baseline and after 3 months. | Blood samples will be collected at baseline and after 3 months | 3 months |
| D000147 |
| Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |