Role of Nigella Sativa Oil as an Adjuvant Therapy in the Treatment of Pediatric Pneumonia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Temperature
研究概览
简要总结
Nigella sativa is the world's oldest immunomodulator. The main active component in Nigella sativa is thymoquinone. Research shows thymoquinone has antioxidant, anti-inflammatory, and antimicrobial effects. Based on these observations on the pharmacological activities of Nigella sativa, the potential therapeutic efficacy of N. Sativa was proposed in CAP.
详细描述
The aim of this work is to assess the benefit of oral Nigella Sativa oil supplementation, in addition to standard antibiotic and other supportive therapy, in the management of hospitalized children with pneumonia admitted to the Pulmonology Unit, Pediatric Department.
Primary outcome:
1- The duration of clinical manifestations of pneumonia including time taken for normalization of respiratory rate, temperature, and oxygen.
saturation, chest in drawing, hypoxia, lethargy, and inability to feed 2- The duration of hospital stay.
Secondary outcome:
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 2 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signs and symptoms of lower respiratory tract infections (LRTI) (LRTI was defined as ≥ 1 of the following: new or different cough or sputum production, chest pain, dyspnea, tachypnea, or abnormal auscultatory findings).
- •Focal findings on chest x-ray indicating pneumonia.
排除标准
- •Children with immunodeficiency, chronic lung disease, malignancy, congenital lung anomalies, underlying disorder impacting respiration i.e. genetic, metabolic, neuromuscular disorders....etc, children with CHD affecting the pulmonary blood flow
研究组 & 干预措施
52 children with community acquired pneumonia will receive Nigella sativa oil capsules
52 children with community-acquired pneumonia will receive Nigella sativa oil in capsules at a dose of 40 mg/kg/day (8), as an adjunct therapy to the usual pneumonia treatment till the recovery of the disease.
干预措施: Nigella Sativa Oil capsule (Drug)
结局指标
主要结局
Temperature
时间窗: 3 days
Duration of defeverness
Respiratory rate
时间窗: 3 days
Time taken for normalization of respiratory rate
Oxygen saturation
时间窗: 3 days
Duration of normal oxygen saturation
Feeding
时间窗: 3 days
Duration of improvement of feeding
Respiratory distress
时间窗: 7 days
Duration of improvement of respiratory distress
Hospital stays
时间窗: 14 days
Duration of hospital stay
次要结局
- Mortality(30 days)
- Pneumonia complications(30 days)
研究者
Rehab Zaki Elmeazawy
Doctor
Tanta University