Effectiveness of homeopathic medicines as add on to institutional management protocol for Acute encephalitis syndrome (AES) in children: An open label randomized placebo controlled trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 622
- 试验地点
- 1
- 主要终点
- Glasgow outcome scale
研究概览
简要总结
Acute Encephalitis Syndrome (AES) denotes inflammation of the brain or of meninges leading to neurological symptoms. In eastern UP since 2006, >2000 cases of AES are reported each year. Preliminary data through an exploratory observational comparative study in homoeopathy showed positive results. The main hypothesis of this open label randomized controlled trial was to evaluate the superiority of individualized homoeopathic medicine along with institutional management protocol compared to standardized institutional management protocol alone through Glasgow outcome scale. The trial was conducted in IPD setting at BRD Medical College and Hospital, Gorakhpur. The assessment was done at discharge or last follow up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 6.00 Month(s) 至 17.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢Age 6 months to less than 18 years •Acute onset of fever, •Change in mental status (including symptoms such as confusion, disorientation, coma or inability to talk) with /without onew onset of seizure oOther clinical findings may include irritability, somnolence, or abnormal behaviour greater than seen with usual febrile illness.
- •â€¢Written Informed consent.
排除标准
- •Known pre existing illness such as HIV, cancer, febrile convulsions.
结局指标
主要结局
Glasgow outcome scale
时间窗: the study will be in IPD setting. Assessment will be done at discharge tailored to patient at 15-30 days
次要结局
- group of homoeopathic medicines used(at end of the study)