Efficacy of Homoeopathic interventions Cuprum metallicum 30C and Camphor 30C in preventing childhood diarrhoea at urban slums of Delhi - cluster randomized, double blind, placebo-controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 7,000
- 试验地点
- 1
- 主要终点
- Incidence of diarrhoea
研究概览
简要总结
The study will be a cluster randomised, double-blind, placebo controlled trial wherein apparently healthy children of age 1 - 10 years residing in slums of Holambi kalan of Delhi, shall be enrolled in the study. Health workers shall screen children who fulfill the inclusion criteria for the enrollment in the study. The children will be enrolled into 3 groups and shall receive medicine as per dosage pattern assigned.
- Group 1 - Approx. population of 2000 receiving Cuprum metallicum 30C
- Group 2 - Approx. population of 2000 receiving Camphor 30C
- Group 3 - Approx. population of 2000 receiving placebo
The dosage of medicine and placebo shall be one dose (4 pills) per week for initial 2 months after enrollment, thereafter one dose (4 pills) fortnightly for next 2 months (3rd & 4th month) and subsequently one dose (4 pills) per month for last 20 months (5th – 24th month). I.E.C material regarding prevention of diarrhoeal diseases shall be given to participants in all 03 groups. The participants will be observed weekly for medicine compliance and for incidences of diarrhea. Primary outcome measure will be comparison of incidence of diarrhea between the groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 1.00 Year(s) 至 10.00 Year(s)(—)
- 性别
- All
入选标准
- •Voluntary written informed consent by the parent/ guardian.
- •No diarrhoea at the time of enrolment to study.
排除标准
- •Diarrhea during last 7 days.
- •Child taking any other Homeopathic medicines.
- •Child seeking treatment for any other diseases or life-threatening complications or suffering from any other immuno-compromised disease.
- •Parents refused to give written informed consent.
结局指标
主要结局
Incidence of diarrhoea
时间窗: Weekly
次要结局
- Duration of diarrhoeal episode(Weekly)
- Hospitalization rates for diarrheal episode(Weekly)
- Usage of conventional medication for diarrheal episode(Weekly)
- Frequency of diarrheal episodes during study period.(Weekly)
