The Effect of Gingko Biloba on the Clinical Outcome of Rheumatoid Arthritis Patients
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- HsCRP
研究概览
简要总结
this study aims to measure The Effect of Gingko Biloba on the Clinical Outcome of Rheumatoid Arthritis Patients ,the outcomes are hsCRp,calprotectin,DAS-28,HAQ-DI
详细描述
Rheumatoid arthritis (RA) is a systemic progressive inflammatory disease characterized by joint injury and cartilage destruction. Up-regulation of T-helper17 (Th17) cells and down-regulation of regulatory T (Treg) cells are among the features of RA pathogenesis which led to inflammation.The first line management strategy of RA is based on using conventional synthetic disease modifying anti-rheumatic drugs
, however,many RA patients either do not respond or develop resistant to csDMARDs. Meanwhile, several biologic DMARDs have been reported to improve RA outcomes but the high cost make them unaffordable for many patients. Hence, alternative low-cost strategies are needed to control RA disease activity and improve patients' QOL.
Ginkgolide B (GB) is an extract of the leaves of Ginkgo biloba containing terpene lactones (which most notably include ginkgolides and diterpenes) and ginkgo flavone glycosides (which most notably contain ginkgetin, bilobetin, and sciadopitysin). The anti-inflammatory and anti-apoptotic activities of GB have been proven in diabetes and osteoarthritis. GBLE has also an antioxidant action as a free radical scavenger, an improving effect on blood flow or microcirculation, and a stimulating effect on neurotransmitters. However, to the best of our knowledge, no studies have evaluated the benefits of GB in RA patients.
Thus, the current study is the first randomized controlled trial to evaluate the efficacy and safety of GB on inflammation and quality of life in RA patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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 (older than 18 years)
- •With moderate to high disease activity defined as DAS-28 score ≥ 3.2
- •Patients receiving stable regimen of one or more csDMARDs for the past 6 months
排除标准
- •Patients with known hypersensitivity to Ginkgo biloba
- •Patients receiving Ginkgo biloba for any other indications
- •Patients on biologic DMARDs
- •Patients with impaired liver functions (liver transaminases level ≥ three times upper normal limits), impaired kidney functions (estimated glomerular filtration rate (eGFR) < 30 ml/min),
- •Patients with any of the following comorbidities: congestive heart failure, history of myocardial infarction, severe anemia, active infections, other inflammatory diseases, and malignancies.
- •6. Patients with other autoimmune diseases
结局指标
主要结局
HsCRP
时间窗: baseline and 12 weeks
* Blood samples will be drawn from the patients at baseline and after 12 weeks of intervention Blood samples will be collected at baseline ,centrifuged and stored as serum at -80 °C until analysis. * Hs-CRP will be evaluated by for each patient at baseline and after 12 weeks using commercial ELISA kits
次要结局
- calprotectin(baseline and 12weeks)
- DAS-28(baseline and 3 months)
- Quality of life assessment(at baseline and after 12 weeks)
研究者
Nuran Sameh
noran sameh ahmed
Ain Shams University