Efficacy and Safety of Resveratrol in Patients With Rheumatoid Arthritis.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAin Shams University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patients receiving biologic DMARDs therapy for RA

Patients taking any other anti-inflammatory drugs

Patients taking any other antioxidants

Pregnant and lactating women

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Methotrexate

    Drug

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

Treatment groups

118 Participants
are divided into 2 treatment groups
Group A: Resveratrol groupExperimental treatment 1 intervention
Group B: Control armActive comparator 1 intervention

Trial outcomes

Primary outcomes

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)

Time frame
From 3 to 6 Months

Secondary outcomes

1

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

Time frame
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).

Time frame
From 3 to 6 Months.

Other outcomes

1

To assess any adverse effects related to Resveratrol.

Time frame
From 3 to 6 Months.

Sponsors and contacts

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