Efficacy and Safety of Resveratrol in Patients With Rheumatoid Arthritis.

NCT07089381 | Recruiting DMC

• 1 other identifier: 338
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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 :

• Serum Sirtuin 1(SIRT1)
• Serum Myeloperoxidase (MPO)
• Serum C-reactive protein (CRP)
• To investigate the effects of Resveratrol on disease activity by measuring the disease activity (DAS28 score).
• To investigate the effect of Resveratrol on improving the quality of life using the Health Assessment Questionnaire Disability index (HAQ-DI).
• To assess any adverse effects related to Resveratrol.
• Control group: 59 patients will receive the standard treatment for management of RA for 3 months.
• 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

Outcome Measures

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)

  From 3 to 6 Months

Secondary Outcomes (2)

• 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.

Other Outcomes (1)

• To assess any adverse effects related to Resveratrol.

  From 3 to 6 Months.

Study Arms (2)

Resveratrol group

EXPERIMENTAL

59 patients will receive the standard treatment for management of RA in addition to Resveratrol 1 gm daily for three month daily.

Dietary Supplement: Resveratrol 1 gm.

Control arm

ACTIVE COMPARATOR

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

Drug: Methotrexate

Interventions

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.

Resveratrol group

Methotrexate DRUG

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

Control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

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

Cairo, Egypt

RECRUITING

Related Publications (8)

• Wang G, Xie X, Yuan L, Qiu J, Duan W, Xu B, Chen X. Resveratrol ameliorates rheumatoid arthritis via activation of SIRT1-Nrf2 signaling pathway. Biofactors. 2020 May;46(3):441-453. doi: 10.1002/biof.1599. Epub 2019 Dec 28.

  PMID: 31883358 BACKGROUND

• Kciuk M, Garg A, Rohilla M, Chaudhary R, Dhankhar S, Dhiman S, Bansal S, Saini M, Singh TG, Chauhan S, Mujwar S, Gielecinska A, Kontek R. Therapeutic Potential of Plant-Derived Compounds and Plant Extracts in Rheumatoid Arthritis-Comprehensive Review. Antioxidants (Basel). 2024 Jun 27;13(7):775. doi: 10.3390/antiox13070775.

  PMID: 39061843 BACKGROUND

• Mousavi SE, Nejadghaderi SA, Khabbazi A, Alizadeh M, Sullman MJM, Kaufman JS, Collins GS, Safiri S. The burden of rheumatoid arthritis in the Middle East and North Africa region, 1990-2019. Sci Rep. 2022 Nov 11;12(1):19297. doi: 10.1038/s41598-022-22310-0.

  PMID: 36369238 BACKGROUND

• Poniewierska-Baran A, Bochniak O, Warias P, Pawlik A. Role of Sirtuins in the Pathogenesis of Rheumatoid Arthritis. Int J Mol Sci. 2023 Jan 12;24(2):1532. doi: 10.3390/ijms24021532.

  PMID: 36675041 BACKGROUND

• Diab A, Omar A, Maaty A, Abdalla M. Plasma and Synovial Fluid Levels of Myeloperoxidase in Patients with Rheumatoid Arthritis and Its Correlation with Disease Activity. Suez Canal University Medical Journal. 2023;26(2):0-0. doi:10.21608/scumj.2023.304689

  BACKGROUND

• Garcia-Martinez BI, Ruiz-Ramos M, Pedraza-Chaverri J, Santiago-Osorio E, Mendoza-Nunez VM. Effect of Resveratrol on Markers of Oxidative Stress and Sirtuin 1 in Elderly Adults with Type 2 Diabetes. Int J Mol Sci. 2023 Apr 18;24(8):7422. doi: 10.3390/ijms24087422.

  PMID: 37108584 BACKGROUND

• Oliveira ALB, Monteiro VVS, Navegantes-Lima KC, Reis JF, Gomes RS, Rodrigues DVS, Gaspar SLF, Monteiro MC. Resveratrol Role in Autoimmune Disease-A Mini-Review. Nutrients. 2017 Dec 1;9(12):1306. doi: 10.3390/nu9121306.

  PMID: 29194364 BACKGROUND

• Khojah HM, Ahmed S, Abdel-Rahman MS, Elhakeim EH. Resveratrol as an effective adjuvant therapy in the management of rheumatoid arthritis: a clinical study. Clin Rheumatol. 2018 Aug;37(8):2035-2042. doi: 10.1007/s10067-018-4080-8. Epub 2018 Apr 3.

  PMID: 29611086 BACKGROUND

MeSH Terms

Conditions

Rheumatic Fever; Arthritis, Rheumatoid

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Lamia El-Wakeel, Professor of Clinical Pharmacy

  Clinical Pharmacy Department, Faculty of Pharmacy, Ain Shams University

  STUDY DIRECTOR

• Sarah Zaki, Professor of Clinical Pharmacy

  Clinical Pharmacy Departement, Faculty of Pharmacy, Ain Shams University

  STUDY DIRECTOR

• Al Shymaa Farouk, Lecturer of Internal Medicine

  Rheumatology and Clinical Immunology, Faculty of Medicine, Ain Shams University

  STUDY CHAIR

• Rana El-Dash, Assistant Lecturer

  Clinical Pharmacy Department, Faculty of Pharmacy, Ain Shams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rana El-Dash, MsC

CONTACT

+201023669009; rana.mahmoudali@pharma.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer/Pharmacist

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: July 28, 2025
• Study Start: August 1, 2025
• Primary Completion: February 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 28, 2025

Record last verified: 2025-07

Locations

EG (1)