Efficacy and Safety of Resveratrol in Patients With Rheumatoid Arthritis.

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.

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.

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.

DRUG

Methotrexate

59 patients will receive the standard treatment for management of RA for 3 months

Sponsors & Collaborators

• Ain Shams University

  lead OTHER

Principal Investigators

• Lamia El-Wakeel, Professor of Clinical Pharmacy · Clinical Pharmacy Department, Faculty of Pharmacy, Ain Shams University

• Sarah Zaki, Professor of Clinical Pharmacy · Clinical Pharmacy Departement, Faculty of Pharmacy, Ain Shams University

• Al Shymaa Farouk, Lecturer of Internal Medicine · Rheumatology and Clinical Immunology, Faculty of Medicine, Ain Shams University

• Rana El-Dash, Assistant Lecturer · Clinical Pharmacy Department, Faculty of Pharmacy, Ain Shams University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-08-01

Primary Completion

2026-02-01

Completion

2026-06-01

Countries

• Egypt

Study Locations