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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 :
To investigate the effects of Resveratrol on inflammation and oxidative stress by measuring:
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.
Patients:
Eligible patients (no=118) will be randomly assigned in a 1:1 ratio to one of two groups:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control arm | Active Comparator | 59 patients will receive the standard treatment for management of RA for 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| To assess any adverse effects related to Resveratrol. | From 3 to 6 Months. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rana El-Dash, MsC | Contact | +201023669009 | rana.mahmoudali@pharma.asu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Rheumatology at Ain Shams university hospital, Cairo, Egypt | Recruiting | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31883358 | Result | 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. | |
| 39061843 | Result | 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. |
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| Methotrexate | Drug | 59 patients will receive the standard treatment for management of RA for 3 months |
|
| From 3 to 6 Months. |
| 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 |
| 36369238 | Result | 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. |
| 36675041 | Result | 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. |
| Result | 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 |
| 37108584 | Result | 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. |
| 29194364 | Result | 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. |
| 29611086 | Result | 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. |
| ID | Term |
|---|---|
| D012213 | Rheumatic Fever |
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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