Evaluating the Efficacy of Channa Striata in Stabilizing eNOS in Patients With Septic: A Randomized Control Trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Endothelial Nitric Oxide Synthase
研究概览
简要总结
Sepsis is an inflammation response produced by the host's immune system, which is agrravated by oxidative stress. One of the adjuvant therapy according to Surviving Sepsis Campaign Guideline is albumin, which has anti-inflammatory and anti-oxidant effects. However, human albumin is quite expensive, and other forms with similar potency and less costs are needed, one of which is Channa striata extract. Therefore, this study is conducted to compare albumin and human albumin, specifically their anti- inflammatory and anti-oxidant properties by assessing the eNOS marker, neutrophil/lymphocyte ratio (NLR) and platelet/lymphocyte ratio (PLR) in patient with sepsis.
详细描述
In summary, this study showed that Channa striata extract has a better outcome in stabilizing eNOS level in patient with sepsis than human albumin 20%, and it has a potential benefit in stabilizing NLR values. However, further studies with a larger sample and a more advanced phase of sepsis are needed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •patients sepsis who met the qSOFA criteria ≧ 2 [two of which: unconsciousness (Glasgow Coma Scale ≤14)
- •respiratory rate > 22 and systolic blood pressure ≤ 100 mmHg],
- •aged ≧ 18 years
- •admitted to intensive care unit and high care unit at Dr. Moewardi General Hospital
排除标准
- •patients with severe trauma
- •blood loss in stage three or higher
- •stress ulcers
- •a history of nephrotic syndrome
- •refusal to participate
结局指标
主要结局
Endothelial Nitric Oxide Synthase
时间窗: three days after treatment
Measured before and three days after treatment, and the examiners compare the three markers statistically.
次要结局
- Neutrophil-Lymphocyte Ratio(three days after treatment)
- Platelet-Lymphocyte Ratio(three days after treatment)
研究者
Septian Adi Permana
Intensivist
Universitas Sebelas Maret