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Recruiting Phase 3

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

NCT05756179 · tracked via the Priya Life Science Egypt tracker
Phase
Phase 3
Started
2023-07-18
Last updated
2025-04-25

Condition(s) studied

Rheumatoid Arthritis

Investigational drug(s) / intervention(s)

Diosmin and Hesperidin Combination →

Diosmin and Hesperidin Combination: Diosmin 450 mg and Hesperidin 50 mg Combination

Study summary

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

Eligibility

Sex
ALL
Min age
19 Years
Max age
65 Years
Healthy volunteers
No
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 (tumor necrosis factor- α) or IL-1β (interleukin-1β) antagonists.

Primary outcome measure(s)

  • 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.

Trial sites (1)

FacilityCityRegionStatus
Alexandria university hospital Alexandria Egypt Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05756179 on ClinicalTrials.gov ↗ ← All trials in Egypt