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NCT Number: NCT05756179

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

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

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Alexandria university hospital

Alexandria, Egypt

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diosmin and Hesperidin Combination

Drug

Diosmin 450 mg and Hesperidin 50 mg Combination

Other names: Diosmin Plus 500 mg tablet

Primary outcomes

  1. Anti inflammatory Effect

    Time frame: 3 months

    Measure the change in serum level of IL-1β (interleukin 1β) at baseline and after treatment in both groups

  2. Effect on disease activity

    Time frame: 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 outcomes

  1. Hepatoprotective Effect

    Time frame: 3 months

    Measure the change in serum level of Liver enzymes (ALT & AST) at baseline and after treatment in both groups.

Study contacts

Contact information is provided by the study sponsor or research team.

AHMED ABDELBAR, MSc

CONTACT

[email protected]

00201021914588

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Mar 6, 2023
Registry last updated
Apr 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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