Efficacy and Safety of Resveratrol in Patients With Rheumatoid Arthritis.
NCT ID: NCT07089381
Last Updated: 2025-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
118 participants
INTERVENTIONAL
2025-08-01
2026-06-01
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Resveratrol group
59 patients will receive the standard treatment for management of RA in addition to Resveratrol 1 gm daily for three month daily.
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.
Control arm
59 patients will receive the standard treatment for management of RA for 3 months.
Methotrexate
59 patients will receive the standard treatment for management of RA for 3 months
Interventions
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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.
Methotrexate
59 patients will receive the standard treatment for management of RA for 3 months
Eligibility Criteria
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Inclusion Criteria
* 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 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)
18 Years
ALL
No
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Rana El-Dash
Assistant Lecturer/Pharmacist
Principal Investigators
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Lamia El-Wakeel, Professor of Clinical Pharmacy
Role: STUDY_DIRECTOR
Clinical Pharmacy Department, Faculty of Pharmacy, Ain Shams University
Sarah Zaki, Professor of Clinical Pharmacy
Role: STUDY_DIRECTOR
Clinical Pharmacy Departement, Faculty of Pharmacy, Ain Shams University
Al Shymaa Farouk, Lecturer of Internal Medicine
Role: STUDY_CHAIR
Rheumatology and Clinical Immunology, Faculty of Medicine, Ain Shams University
Rana El-Dash, Assistant Lecturer
Role: PRINCIPAL_INVESTIGATOR
Clinical Pharmacy Department, Faculty of Pharmacy, Ain Shams University
Locations
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Department of Rheumatology at Ain Shams university hospital, Cairo, Egypt
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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
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.
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.
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.
Other Identifiers
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338
Identifier Type: -
Identifier Source: org_study_id
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