Rheumatic ArthritisNCT07089381
Efficacy and Safety of Resveratrol in Patients With Rheumatoid Arthritis.
A study testing Resveratrol 1 gm. and Methotrexate in people with Rheumatic Arthritis and Rheumatoid Arthritis (RA) Prevention, run by Ain Shams University at 1 site in Egypt.
Trial 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 : 1. To investigate the effects of Resveratrol on inflammation and oxidative stress by measuring: Serum Sirtuin 1(SIRT1) Serum Myeloperoxidase (MPO) Serum… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatic Arthritis, Rheumatoid Arthritis (RA) Prevention, Inflamation
- What is being tested?
- Resveratrol 1 gm. and Methotrexate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2025to 1 Jun 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Department of Rheumatology at Ain Shams university hospital, Cairo, Egypt
Cairo
Farouk, Doctoral Degree, +201005225137, alshymaafarouk@gmail.com
About this study
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 :
Read more
- 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)
- 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:
- 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
- Being tested
- Resveratrol 1 gm., Methotrexate
- Medical subject headings
- Rheumatic Fever, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
MethotrexateDrug
59 patients will receive the standard treatment for management of RA for 3 months
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Resveratrol 1 gm. |
| Control arm | Active comparator | 59 patients will receive the standard treatment for management of RA for 3 months. Receives: Drug: Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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).
Measured: 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).
Measured: From 3 to 6 Months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Rheumatic ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rana El-Dash, Ain Shams University
- Investigators
- Lamia El-Wakeel, Professor of Clinical Pharmacy, Study director, Clinical Pharmacy Department, Faculty of Pharmacy, Ain Shams UniversitySarah Zaki, Professor of Clinical Pharmacy, Study director, Clinical Pharmacy Departement, Faculty of Pharmacy, Ain Shams UniversityAl Shymaa Farouk, Lecturer of Internal Medicine, Study chair, Rheumatology and Clinical Immunology, Faculty of Medicine, Ain Shams UniversityRana El-Dash, Assistant Lecturer, Principal investigator, Clinical Pharmacy Department, Faculty of Pharmacy, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07089381
- Sponsor's protocol ID
- 338
- Status last verified
- Jul 2025
- First submitted
- 21 Jul 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31883358Kciuk 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.
PubMed 39061843Mousavi 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.
PubMed 36369238Poniewierska-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.
PubMed 36675041Diab 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.
PubMed 37108584Oliveira 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.
PubMed 29194364Khojah 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.
PubMed 29611086