Efficacy of Homoeopathic intervention Eupatorium perfoliatum 30 in preventing Dengue at urban slums of Delhi - cluster-randomized, double-blind, placebo-control trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Incidence of Dengue between the groups
研究概览
简要总结
Dengue has risen exponentially over the last two decades and has accorded a huge burden on economy and health infrastructure of countries especially those that are developing. Due to its high population density, India has shown vulnerability for rapidly evolving micro-organisms such as dengue. This cluster-randomized, double-blind, placebo-controlled trial aims to evaluate the efficacy of Eupatorium perfoliatum 30 in preventing dengue among residents of 20 urban slum clusters in Delhi. Participants will receive weekly doses of the intervention or placebo from July to October for two years, along with IEC materials. Primary outcome is incidence of dengue. Secondary outcomes include incidence and severity of acute undifferentiated febrile illness and mean duration of illness. The study will generate robust clinical evidence on the preventive role of homeopathy against dengue and other febrile illnesses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 1.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •Voluntary written informed consent by the family head.
排除标准
- •Pregnant women and lactating mother Child below age of 1 year Individuals taking other preventive medicines for dengue.
- •Patients with malignancy, immune-compromised state, life threatening diseases, end stage diseases.
- •Symptom of acute febrile illness/ Dengue like illness at the time of enrolment.
- •Patient with symptoms of acute infectious illnesses at the time of enrolment.
- •Not willing to give written informed consent.
结局指标
主要结局
Incidence of Dengue between the groups
时间窗: Weekly
次要结局
- Incidence of AUFI between the groups(Weekly)
- Changes/severity of symptoms between the groups during post prophylactic/ climatic infections(at the time of analysis)
- Mean duration of acute febrile illnesses between the cohorts(Weekly)
研究者
Dr Debadatta Nayak
Central Council for Research in Homoeopathy
