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

Sponsor
Alexandria University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05756179
Collaborator
(none)
80
Enrollment
2
Arms
26.1
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Diosmin and Hesperidin Combination
 Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Clinical Study Evaluating the Effect of Diosmin and Hesperidin in Treatment of Patients With Rheumatoid Arthritis
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Sep 1, 2025

Arms and Interventions

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:
  • Dafrex tablet
  • Diosmin Plus 500 mg tablet

    		•
    No Intervention: Control group

    Conventional Therapy (Methotrexate) only

    Outcome Measures

    Primary Outcome Measures

    1. Anti inflammatory Effect [3 months]

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

    2. 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

    1. Hepatoprotective Effect [3 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts 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 or IL-1β antagonists.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alexandria University
    ClinicalTrials.gov Identifier:
    NCT05756179
    Other Study ID Numbers:
    • 0201734
    First Posted:
    Mar 6, 2023
    Last Update Posted:
    Mar 6, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Arthritis
    Arthritis, Rheumatoid

    Study Results

    No Results Posted as of Mar 6, 2023