Rheumatoid Arthritis (RA)
Conditions
Keywords
rheumatoid arthritis, diosmin, rebamipide
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.
Interventions
DRUGDiosmin
1000 mg diosmin once daily for 3 months
DRUGRebamipide 100mg
100 mg rebamipide three times daily for 3 months
conventional medical treatment for RA
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change in Disease Activity score-CRP (DAS28-CRP) | 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\] |
| The change in The Health Assessment Questionnaire-Disability Index (HAQ-DI) score | 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Egypt
Contacts
CONTACTkhlood mohamed kettana, assistant lecturer
Outcome results
None listed