NCT07089381 Efficacy and Safety of Resveratrol in Patients With Rheumatoid Arthritis.
| NCT ID | NCT07089381 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ain Shams University |
| Condition | Rheumatic Arthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 118 participants |
| Start Date | 2025-08-01 |
| Primary Completion | 2026-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 118 participants in total. It began in 2025-08-01 with a primary completion date of 2026-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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)
Contact & Investigator
Lamia El-Wakeel, Professor of Clinical Pharmacy
STUDY DIRECTOR
Clinical Pharmacy Department, Faculty of Pharmacy, Ain Shams University
Frequently Asked Questions
Who can join the NCT07089381 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Rheumatic Arthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07089381 currently recruiting?
Yes, NCT07089381 is actively recruiting participants. Contact the research team at rana.mahmoudali@pharma.asu.edu.eg for enrollment information.
Where is the NCT07089381 trial being conducted?
This trial is being conducted at Cairo, Egypt.
Who is sponsoring the NCT07089381 clinical trial?
NCT07089381 is sponsored by Ain Shams University. The principal investigator is Lamia El-Wakeel, Professor of Clinical Pharmacy at Clinical Pharmacy Department, Faculty of Pharmacy, Ain Shams University. The trial plans to enroll 118 participants.