NCT07089381招募中不适用
Efficacy and Safety of Resveratrol in Patients With Rheumatoid Arthritis.
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- 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)
研究概览
简要总结
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 :
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •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.
排除标准
- •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
- •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)
研究组 & 干预措施
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.
干预措施: Resveratrol 1 gm. (Dietary Supplement)
Control arm
Active Comparator
59 patients will receive the standard treatment for management of RA for 3 months.
干预措施: Methotrexate (Drug)
结局指标
主要结局
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)
时间窗: From 3 to 6 Months
次要结局
- 2. To investigate the effects of Resveratrol on disease activity by measuring the disease activity (DAS28 score).(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).(From 3 to 6 Months.)
研究者
Rana El-Dash
Assistant Lecturer/Pharmacist
Ain Shams University
研究点 (1)
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