Therapeutic Evaluation of Sharbat Khaksi and Cefixime vs Paracetamol and Cefixime in Pediatric Typhoid Fever: A Randomized Parallel Arm Open Label Interventional Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Fever clearance time (FCT)
研究概览
简要总结
This is a randomized, open-label, parallel-arm clinical trial to compare the efficacy of a Unani formulation, Sharbat Khaksi, against Paracetamol in managing fever for pediatric typhoid. The study will enroll 70 children aged 5-12 years with blood culture-confirmed uncomplicated typhoid fever. Participants will be randomly assigned to either the trial group, receiving Sharbat Khaksi and Cefixime, or the control group, receiving Paracetamol and Cefixime, for a duration of 14 days. The primary objective is to evaluate the difference in Fever Clearance Time (FCT) between the two groups. Secondary outcomes will include the assessment of improvement in subjective symptoms like weakness, fatigue, headache, and abdominal pain, with follow-ups on days 3, 6, 8, and 14.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 5.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •A history of fever and presentation for more than or equals to 72 hours and a documented fever [99.5 degree fahrenheit to 102 degree fahrenheit (axillary)].
- •Cases of positive Blood culture of S typhi Patients whose parents or guardian or LAR will give consent and able to do follow-up.
排除标准
- •Patients who had received intravenous or oral antibiotics before getting Blood culture of S typhi.
- •Clinically diagnosed cases of malaria and dengue.
- •Patients with known other systemic disease.
- •Previous history of hypersensitivity to any of the trial drugs.
- •Complicated typhoid fever cases suffers from melena, severe abdominal discomfort, hepatic encephalopathy.
- •Any concomitant treatment like anti-depressants or anticonvulsants.
结局指标
主要结局
Fever clearance time (FCT)
时间窗: 14 days
次要结局
- Improvement in other Subjective parameters(14 days)
研究者
Dr Sudhanshu
State Unani Medical College and Hospital Himmatganj Prayagraj