Clinical Study Comparing Diosmin vs Rebamipide as Adjuvant Therapies vs Conventional Therapy in Patients With Rheumatoid Arthritis | NCT07745426

NCT07745426

Overview

NCT ID: NCT07745426
Lead Sponsor: Tanta UniversityOTHER
Official Title: Clinical Study Comparing Diosmin vs Rebamipide as Adjuvant Therapies vs Conventional Therapy in Patients With Rheumatoid Arthritis
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.

Status and Timeline

Status: Recruiting
Last Update Posted: Aug 4, 2026Actual
Start Date: Aug 1, 2026Estimated
Primary Completion Date: Aug 1, 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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.

Study Plan

Study Type: Interventional
Phase: Phase 2
Enrollment: 66Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking

Contacts and Locations

Central Contacts: khlood mohamed kettana, assistant lecturerContact
khlood.kettana@pharm.tanta.edu.eg

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