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

NCT07745426 | Recruiting Phase 2

• 1 other identifier: 36265MD41021/1/26
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rheumatoid Arthritis (RA)

Keywords

rheumatoid arthritis; diosmin; rebamipide

Outcome Measures

Primary Outcomes (2)

• The change in Disease Activity score-CRP (DAS28-CRP)

  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\]

  At baseline and after three months of the intervention

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

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

  At baseline and after three months of the intervention

Secondary Outcomes (3)

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

  three months

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

  three months

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

  three months

Study Arms (3)

Group 1 (control group):

ACTIVE COMPARATOR

will include 22 patients who will receive the conventional therapy for RA for 3 months.

Drug: Convential medical treatment

Group 2 (diosmin group):

ACTIVE COMPARATOR

will include 22 patients who will receive the conventional therapy for RA plus 1000 mg diosmin once daily for 3 months.

Drug: Diosmin; Drug: Convential medical treatment

Group 3 (rebamipide group):

ACTIVE COMPARATOR

will include 22 patients who will receive the conventional therapy for RA plus 100 mg rebamipide three times daily for 3 months.

Drug: Rebamipide 100mg; Drug: Convential medical treatment

Interventions

Diosmin DRUG

1000 mg diosmin once daily for 3 months

Group 2 (diosmin group):

Rebamipide 100mg DRUG

100 mg rebamipide three times daily for 3 months

Group 3 (rebamipide group):

Convential medical treatment DRUG

conventional medical treatment for RA

Group 1 (control group):; Group 2 (diosmin group):; Group 3 (rebamipide group):

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of Pharmacy Tanta University

Tanta, Egypt

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Diosmin; rebamipide

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

Central Study Contacts

khlood mohamed kettana, assistant lecturer

CONTACT

01091100037; khlood.kettana@pharm.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical pharmacy assistant lecturer

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 4, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: August 4, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)