Resveratrol added to usual treatment for moderate-to-high rheumatoid arthritis
Efficacy and Safety of Resveratrol in Patients With Rheumatoid Arthritis.
This will see if giving adults with moderate-to-high rheumatoid arthritis 1 g of resveratrol daily alongside their usual medicines for three months reduces inflammation, disease activity, and improves quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 118 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT07089381 on ClinicalTrials.gov |
What this trial studies
This randomized, controlled study will enroll 118 adults with established rheumatoid arthritis and moderate-to-high disease activity and assign them 1:1 to standard care alone or standard care plus 1 g daily resveratrol for three months. Investigators will measure inflammatory and oxidative-stress biomarkers (SIRT1, MPO, CRP), clinical disease activity (DAS28-CRP), and functional status (HAQ-DI), and will monitor for adverse effects. Patients must be on a stable regimen of conventional synthetic DMARDs and cannot be receiving biologics or other antioxidants. The trial is conducted at the Department of Rheumatology, Ain Shams University Hospital in Cairo, Egypt.
Who should consider this trial
Good fit: Adults 18 or older with an established RA diagnosis (ACR/EULAR 2010) and moderate-to-high disease activity (DAS28-CRP > 3.2) who have been on a stable csDMARD regimen for at least three months are eligible.
Not a fit: Patients on biologic DMARDs, taking other anti-inflammatory drugs or antioxidants, smokers, pregnant or lactating people, those with significant liver impairment, other inflammatory/rheumatologic diseases, malignancy, or thyroid disease are excluded and would not be eligible to benefit from this protocol.
Why it matters
Potential benefit: If successful, adding resveratrol could reduce inflammation and disease activity and improve quality of life for people with RA when used alongside standard therapy.
How similar studies have performed: Preclinical work and small clinical studies suggest resveratrol has antioxidant and anti-inflammatory effects, but well-powered randomized trials in RA are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Cairo
- Department of Rheumatology at Ain Shams university hospital, Cairo, Egypt — Cairo, Egypt (Recruiting)
Study contacts
- Principal investigator: Rana El-Dash, Assistant Lecturer — Clinical Pharmacy Department, Faculty of Pharmacy, Ain Shams University
- Study coordinator: Rana El-Dash, MsC
- Email: rana.mahmoudali@pharma.asu.edu.eg
- Phone: +201023669009
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.