Anti Aging, Antioxidant, Anti Oxidative Stress, C Reactive Protein, Inflamation, Methotrexate, Quality of Life Outcomes, Rheumatic Arthritis, Rheumatoid Arthritis (RA) Prevention
Conditions
Brief summary
The aim of the current study is to evaluate the effects of resveratrol on the clinical outcome(s) of patients with moderate rheumatoid arthritis. Objectives : 1. To investigate the effects of Resveratrol on inflammation and oxidative stress by measuring: * Serum Sirtuin 1(SIRT1) * Serum Myeloperoxidase (MPO) * Serum C-reactive protein (CRP) 2. To investigate the effects of Resveratrol on disease activity by measuring the disease activity (DAS28 score). 3. To investigate the effect of Resveratrol on improving the quality of life using the Health Assessment Questionnaire Disability index (HAQ-DI). 4. To assess any adverse effects related to Resveratrol. Patients: Eligible patients (no=118) will be randomly assigned in a 1:1 ratio to one of two groups: 1. Control group: 59 patients will receive the standard treatment for management of RA for 3 months. 2. Resveratrol group: 59 patients will receive the standard treatment for management of RA in addition to Resveratrol 1 gm daily, (Organix Egypt) (given as one 1000 mg tablets once daily) for 3 months.
Interventions
DIETARY_SUPPLEMENTResveratrol 1 gm.
59 patients will receive the standard treatment for management of RA in addition to Resveratrol 1 gm daily, (Organix, Egypt) (given as one 1000 mg tablets once daily) for 3 months.
DRUGMethotrexate
59 patients will receive the standard treatment for management of RA for 3 months
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients \> 18 years old * Established diagnosis of RA according to American College of Rheumatology/European league Against Rheumatism (ACR/EULAR) 2010 criteria (Aletaha et al., 2010), presented with moderate to high disease activity identified as disease activity score-28 based on C-reactive protein (CRP) levels (DAS-28-CRP) \>3.2. * Patients receiving stable regimen of one or more csDMARDs for at least the past 3 months. * RA Patients with Moderate or high disease activity identified as disease activity score-28 based on C-reactive protein (CRP) levels (DAS-28-CRP) \>3.2.
Exclusion criteria
* Patients receiving biologic DMARDs therapy for RA * Patients taking any other anti-inflammatory drugs * Patients taking any other antioxidants * Pregnant and lactating women * Other rheumatological, inflammatory diseases or malignancies * Smokers * Thyroid illnesses * Patients with impaired liver functions (liver transaminases level ≥ three times upper normal limits), impaired kidney functions (estimated glomerular filtration rate (eGFR) \< 30 ml/min)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate the effects of Resveratrol on inflammation and oxidative stress by measuring: • Serum Sirtuin 1(SIRT1) • Serum Myeloperoxidase (MPO) • Serum C-reactive protein (CRP) | From 3 to 6 Months |
Secondary
| Measure | Time frame |
|---|---|
| 2. To investigate the effects of Resveratrol on disease activity by measuring the disease activity (DAS28 score). | From 3 to 6 Months. |
| To investigate the effect of Resveratrol on improving the quality of life using the Health Assessment Questionnaire Disability index (HAQ-DI). | From 3 to 6 Months. |
Other
| Measure | Time frame |
|---|---|
| To assess any adverse effects related to Resveratrol. | From 3 to 6 Months. |
Countries
Egypt
Contacts
Primary ContactRana El-Dash, MsC
Outcome results
None listed