Resveratrol added to usual treatment for moderate-to-high rheumatoid arthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.