Efficacy and Safety of Resveratrol in Patients With Rheumatoid Arthritis.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAin Shams University

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

Patients receiving biologic DMARDs therapy for RA

Patients taking any other anti-inflammatory drugs

Patients taking any other antioxidants

Pregnant and lactating women

Trial design

Treatments tested in this trial

  • Resveratrol 1 gm.
  • Methotrexate

Treatment groups

118 Participants
are divided into 2 treatment groups

Sponsors and collaborators