Effect of Diosmin and Hesperidin in Treatment of Patients With Rheumatoid Arthritis

Study Overview
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Brief Summary
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Evaluating the effect of the flavonoids combination (diosmin and hesperidin) as adjuvant therapy on patients with rheumatoid arthritis

Detailed Description
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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.

Official Title
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Clinical Study Evaluating the Effect of Diosmin and Hesperidin in Treatment of Patients With Rheumatoid Arthritis

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: Diosmin and Hesperidin Combination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with mild to moderate disease activity. Patient age must be more than 18 years. Exclusion Criteria: Pregnant and lactating females. Patients with liver, renal impairment or any other inflammatory diseases. Patients on TNF-α or IL-1β antagonists.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention group<br>Diosmin 450 mg and Hesperidin 50 mg Combination /tablet/ twice daily for 3 months + Conventional Therapy (Methotrexate) | Drug: Diosmin and Hesperidin Combination<br>* Diosmin 450 mg and Hesperidin 50 mg Combination<br>* Other names: Diosmin Plus 500 mg tablet;|
| No Intervention: Control group<br>Conventional Therapy (Methotrexate) only | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti inflammatory Effect | Measure the change in serum level of IL-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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |