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NCT Number: NCT07745426

Clinical Study Comparing Diosmin vs Rebamipide as Adjuvant Therapies vs Conventional Therapy in Patients With Rheumatoid Arthritis

This study will be a randomized controlled parallel study that will be conducted on 66 patients with active rheumatoid arthritis who will be diagnosed with RA according to American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR, 2010). The patients will be recruited from Outpatient Clinic of Rheumatology, Physical Medicine, Rheumatology and Rehabilitation Department, Tanta University Hospital, Tanta, Egypt. The study duration will be 3 months. The patients will be randomized into three groups:

- Group 1 (control group): will include 22 patients who will receive the conventional therapy for RA for 3 months.

- Group 2 (diosmin group): will include 22 patients who will receive the conventional therapy for RA plus 1000 mg diosmin once daily for 3 months.

- Group 3 (rebamipide group): will include 22 patients who will receive the conventional therapy for RA plus 100 mg rebamipide three times daily for 3 months.

Recruiting

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of Pharmacy Tanta University

Tanta, Egypt

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with active rheumatoid arthritis (not in remission) according to American College of Rheumatology/European League Against Rheumatism (ACR/EULAR). i.e.,28 joints disease activity score (DAS-28) >2.6.
  • Both sexes.
  • Age ranges between 18 and 70 years old.
  • Patients receiving conventional DMARDs

Exclusion criteria

  • Pregnant and lactating females.
  • Patients receiving biological DMARDs or targeted synthetic DMARDs.
  • Patients with renal and hepatic dysfunction.
  • Patients with other inflammatory/autoimmune diseases, active infection, or malignancies.
  • Patients with bleeding disorders, receiving warfarin or other anticoagulants.
  • Patients receiving antioxidants.
  • Patients with hypersensitivity to study medications.

Treatment and study plan

Diosmin

Drug

1000 mg diosmin once daily for 3 months

Rebamipide 100mg

Drug

100 mg rebamipide three times daily for 3 months

Convential medical treatment

Drug

conventional medical treatment for RA

Primary outcomes

  1. The change in Disease Activity score-CRP (DAS28-CRP)

    Time frame: At baseline and after three months of the intervention

    disease activity will be assessed through: Calculation of 28-joint count Disease Activity Score (DAS28) using C- reactive protein level (CRP) according to the following formula: DAS28-CRP = [0.56*√ (tender joint count) + 0.28*√ (swollen joint count) + 0.36*ln (CRP+1)]*1.10 + 1.15]

  2. The change in The Health Assessment Questionnaire-Disability Index (HAQ-DI) score

    Time frame: At baseline and after three months of the intervention

    the functional status of the participants will be assessed through: The Health Assessment Questionnaire-Disability Index (HAQ-DI)

Secondary outcomes

  1. The change in serum level of C- reactive protein (CRP)

    Time frame: three months

  2. The change in serum level of Tumor necrosis factor-alpha (TNF-α)

    Time frame: three months

  3. The change in serum level of Matrix metalloproteinase-3 (MMP-3)

    Time frame: three months

Study contacts

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

khlood mohamed kettana, assistant lecturer

CONTACT

[email protected]

01091100037

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 4, 2026
Registry last updated
Aug 4, 2026

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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