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

April 24, 2025 updated by: Alexandria University

Clinical Study Evaluating the 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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Recruiting
        • Alexandria University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention group
Diosmin 450 mg and Hesperidin 50 mg Combination /tablet/ twice daily for 3 months + Conventional Therapy (Methotrexate)
Drug: Diosmin and Hesperidin Combination
Diosmin 450 mg and Hesperidin 50 mg Combination
Other Names:
  • Diosmin Plus 500 mg tablet
No Intervention: Control group
Conventional Therapy (Methotrexate) only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months
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
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Investigators

  • Principal Investigator: AHMED ABDELBAR, MSc, College of Pharmacy - Arab Academy for Science and Technology
  • Study Chair: 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 Director: NOHA HAMDI, PhD, Faculty of Pharmacy - Alexandria University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 18, 2023

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

February 21, 2023

First Submitted That Met QC Criteria

March 3, 2023

First Posted (Actual)

March 6, 2023

Study Record Updates

Last Update Posted (Actual)

April 25, 2025

Last Update Submitted That Met QC Criteria

April 24, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0201734

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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