Clinical Study Comparing Diosmin vs Rebamipide as Adjuvant Therapies vs Conventional Therapy in Patients With Rheumatoid Arthritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Diosmin, Rebamipide 100mg, Convential medical treatment.
- Who it may be relevant to
- Registry conditions: Rheumatoid Arthritis (RA). Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Diosmin
1000 mg diosmin once daily for 3 months - Drug Rebamipide 100mg
100 mg rebamipide three times daily for 3 months - Drug Convential medical treatment
conventional medical treatment for RA
Primary outcome measures
- The change in Disease Activity score-CRP (DAS28-CRP) [Time frame: At baseline and after three months of the intervention]
- The change in The Health Assessment Questionnaire-Disability Index (HAQ-DI) score [Time frame: At baseline and after three months of the intervention]
Secondary outcome measures (3)
- The change in serum level of C- reactive protein (CRP) [Time frame: three months]
- The change in serum level of Tumor necrosis factor-alpha (TNF-α) [Time frame: three months]
- The change in serum level of Matrix metalloproteinase-3 (MMP-3) [Time frame: three months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Faculty of Pharmacy Tanta University — Tanta
Identifiers
NCT: NCT07745426 · 36265MD41021/1/26