Efficacy and Safety of Resveratrol in Patients With Rheumatoid Arthritis.

Обзор

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.

Вмешательства

• Пищевая добавка 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.
• Препарат Methotrexate
  59 patients will receive the standard treatment for management of RA for 3 months

Первичные конечные точки

• 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) [Срок оценки: From 3 to 6 Months]

Вторичные конечные точки (2)

• 2. To investigate the effects of Resveratrol on disease activity by measuring the disease activity (DAS28 score). [Срок оценки: 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). [Срок оценки: From 3 to 6 Months.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Египет · 1 центр

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

Публикации

• 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
• 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
• 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
• 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
• 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. PMID 37108584
• 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
• 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

Идентификаторы

NCT: NCT07089381 · 338

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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