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

Phase 3

Recruiting

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Diosmin and Hesperidin Combination

• Registration Number: NCT05756179
• Lead Sponsor: Alexandria University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-02-21
• Study First Submitted QC: 2023-03-03
• Study First Posted: 2023-03-06
• Study Start: 2023-07-18
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-25
• Primary Completion: 2025-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Diosmin and Hesperidin Combination	Diosmin 450 mg and Hesperidin 50 mg Combination /tablet/ twice daily for 3 months + Conventional Therapy (Methotrexate)

Primary Outcome Measures

Name	Time	Method
Anti inflammatory Effect	3 months	Measure the change in serum level of IL-1β (interleukin 1β) at baseline and after treatment in both groups
Effect on disease activity	3 months	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.

Secondary Outcome Measures

Name	Time	Method
Hepatoprotective Effect	3 months	Measure the change in serum level of Liver enzymes (ALT \& AST) at baseline and after treatment in both groups.

Trial Locations

Locations (1)

Alexandria university hospital; 🇪🇬 Alexandria, Egypt