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Evaluating the effect of the flavonoids combination (diosmin and hesperidin) as adjuvant therapy on patients with rheumatoid arthritis
Evaluation of the anti inflammatory and antioxidant effects of the flavonoids combination (diosmin and hesperidin) as adjuvant therapy on patients with rheumatoid arthritis.
Clinical and functional assessment of disease activity.
Evaluation of hepatoprotective effect against methotrexate induced liver adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Active Comparator | Diosmin 450 mg and Hesperidin 50 mg Combination /tablet/ twice daily for 3 months + Conventional Therapy (Methotrexate) |
|
| Control group | No Intervention | Conventional Therapy (Methotrexate) only |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diosmin and Hesperidin Combination | Drug | Diosmin 450 mg and Hesperidin 50 mg Combination |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anti inflammatory Effect | Measure the change in serum level of IL-1β (interleukin 1β) at baseline and after treatment in both groups | 3 months |
| Effect on disease activity | Measure the change in the disease activity at baseline and after 3 months of therapy for each patient in both groups using Disease Activity Score-CRP (DAS28-CRP) which is calculated by a computer based formula consists of several variables: number of swollen joints (0-28), number of tender joints (0-28) and C reactive protein (CRP) (mg/l). A DAS28 value of >5.1 indicates high disease activity, DAS28 ranged from 3.3 to 5.1 indicates moderate disease activity and DAS28 ≤3.2 indicates low disease activity. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Hepatoprotective Effect | Measure the change in serum level of Liver enzymes (ALT & AST) at baseline and after treatment in both groups. | 3 months |
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Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AHMED ABDELBAR, MSc | Contact | 00201021914588 | dr.ahmed_post@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| AHMED ABDELBAR, MSc | College of Pharmacy - Arab Academy for Science and Technology | Principal Investigator |
| AHMED ELMALLAH, PhD | Faculty of Pharmacy - Alexandria University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alexandria university hospital | Recruiting | Alexandria | Egypt |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D004145 | Diosmin |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D047309 | Flavones |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 |
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| MANAL TAYEL, MD |
| Faculty of Medicine - Alexandria Univeristy |
| Study Chair |
| ABEER IBRAHIM, MD | Faculty of Medicine - Alexandria Univeristy | Study Chair |
| NOHA HAMDI, PhD | Faculty of Pharmacy - Alexandria University | Study Director |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |