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

NCT05756179 | Recruiting Phase 3

• 1 other identifier: 0201734
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Hepatoprotective Effect

  3 months

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

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

Drug: Diosmin and Hesperidin Combination

Control group

NO INTERVENTION

Conventional Therapy (Methotrexate) only

Interventions

Diosmin and Hesperidin Combination DRUG

Diosmin 450 mg and Hesperidin 50 mg Combination

Also known as: Diosmin Plus 500 mg tablet

Intervention group

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with mild to moderate disease activity.
• Patient age must be more than 18 years.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria university hospital

Alexandria, Egypt

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Diosmin; Tablets

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Flavones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Dosage Forms; Pharmaceutical Preparations

Study Officials

• AHMED ABDELBAR, MSc

  College of Pharmacy - Arab Academy for Science and Technology

  PRINCIPAL INVESTIGATOR

• AHMED ELMALLAH, PhD

  Faculty of Pharmacy - Alexandria University

  STUDY CHAIR

• 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

Central Study Contacts

AHMED ABDELBAR, MSc

CONTACT

00201021914588; dr.ahmed_post@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: March 6, 2023
• Study Start: July 18, 2023
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)