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NCT Number: NCT07089381

Efficacy and Safety of Resveratrol in Patients With Rheumatoid Arthritis.

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.

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Key information

Conditions

Rheumatic Arthritis Anti Aging Anti Oxidative Stress Antioxidant Arthritis Arthritis, Rheumatoid Autoimmune Diseases Bacterial Infections Bacterial Infections and Mycoses C Reactive Protein Connective Tissue Diseases Gram-Positive Bacterial Infections Immune System Diseases Infections Inflamation Joint Diseases Methotrexate Musculoskeletal Diseases Quality of Life Outcomes Rheumatic Diseases Rheumatic Fever Rheumatoid Arthritis (RA) Prevention Skin and Connective Tissue Diseases Streptococcal Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Rheumatology at Ain Shams university hospital, Cairo, Egypt

Cairo, Egypt

Location status: Recruiting

Location contact

Farouk, Doctoral Degree

CONTACT

[email protected]

+201005225137

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Resveratrol 1 gm.

Dietary Supplement

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.

methotrexate

Drug

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

Primary outcomes

  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)

    Time frame: From 3 to 6 Months

Secondary outcomes

  1. 2. To investigate the effects of Resveratrol on disease activity by measuring the disease activity (DAS28 score).

    Time frame: From 3 to 6 Months.

  2. To investigate the effect of Resveratrol on improving the quality of life using the Health Assessment Questionnaire Disability index (HAQ-DI).

    Time frame: From 3 to 6 Months.

Other outcomes

  1. To assess any adverse effects related to Resveratrol.

    Time frame: From 3 to 6 Months.

Study contacts

Contact information is provided by the study sponsor or research team.

Rana El-Dash, MsC

CONTACT

[email protected]

+201023669009

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 28, 2025
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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