Efficacy and Safety of Resveratrol in Patients With Rheumatoid Arthritis.

Ain Shams University

Status: Enrolling

Conditions: Methotrexate; C Reactive Protein; Anti Aging; Rheumatoid Arthritis (RA) Prevention; Rheumatic Arthritis; Inflamation; Quality of Life Outcomes; Anti Oxidative Stress; Antioxidant

Treatments: Drug: Methotrexate; Dietary Supplement: Resveratrol 1 gm.

Study type: Interventional

Funder types: Other

Identifiers

NCT07089381

338

Details and patient eligibility

About

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.

Enrollment: 118 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

118 participants in 2 patient groups

Resveratrol group

Experimental group

Description:

59 patients will receive the standard treatment for management of RA in addition to Resveratrol 1 gm daily for three month daily.

Treatment:

Dietary Supplement: Resveratrol 1 gm.

Control arm

Active Comparator group

Description:

59 patients will receive the standard treatment for management of RA for 3 months.

Treatment:

Drug: Methotrexate