Efficacy and Safety of Resveratrol in Patients With Rheumatoid Arthritis.

Not Applicable

Recruiting

• Conditions: Rheumatic Arthritis; Rheumatoid Arthritis (RA) Prevention; Inflamation; Antioxidant; Anti Oxidative Stress; Anti Aging; C Reactive Protein; Methotrexate; Quality of Life Outcomes
• Interventions: Dietary Supplement: Resveratrol 1 gm.; Drug: Methotrexate

• Registration Number: NCT07089381
• Lead Sponsor: Ain Shams University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-21
• Study First Submitted QC: 2025-07-21
• Last Update Submitted: 2025-07-21
• Study First Posted: 2025-07-28
• Last Update Posted: 2025-07-28
• Study Start: 2025-08-01
• Primary Completion: 2026-02-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 118

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Resveratrol group	Resveratrol 1 gm.	59 patients will receive the standard treatment for management of RA in addition to Resveratrol 1 gm daily for three month daily.
Control arm	Methotrexate	59 patients will receive the standard treatment for management of RA for 3 months.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Department of Rheumatology at Ain Shams university hospital, Cairo, Egypt; 🇪🇬 Cairo, Egypt