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AzTrials

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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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
Are there results?
Not yet: the study is under way

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.

Rana El-Dash, MsC contact

+201023669009

rana.mahmoudali@pharma.asu.edu.eg

Egypt1 site, 1 recruiting

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

    Cairo

    Farouk, Doctoral Degree, +201005225137, alshymaafarouk@gmail.com

    Recruiting

Other trials in Egypt

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
  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)
  1. To investigate the effects of Resveratrol on disease activity by measuring the disease activity (DAS28 score).
  2. To investigate the effect of Resveratrol on improving the quality of life using the Health Assessment Questionnaire Disability index (HAQ-DI).
  3. 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.
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 groups in NCT07089381
Study groupRoleWhat they receive
Resveratrol groupExperimental59 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 armActive comparator59 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.

  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)

    Measured: From 3 to 6 Months

Secondary outcomes (2)

  1. 2. To investigate the effects of Resveratrol on disease activity by measuring the disease activity (DAS28 score).

    Measured: From 3 to 6 Months.

  2. 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.

  1. First posted28 Jul 2025
  2. Study start1 Aug 2025 (estimated)
  3. Primary completion1 Feb 2026 (estimated)
  4. Study completion1 Jun 2026 (estimated)

Resources

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)
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 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 29611086

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Rana El-Dash, MsC (+201023669009, rana.mahmoudali@pharma.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: From 3 to 6 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07089381, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.

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