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临床试验/CTRI/2023/03/051017
CTRI/2023/03/051017尚未招募3 期

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

Central Council for Research in Homoeopathy, under Ministry of Ayush, Government of India1 个研究点 分布在 1 个国家目标入组 7,000 人开始时间: 2023年4月15日最近更新:
适应症

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)

研究者

发起方
Central Council for Research in Homoeopathy, under Ministry of Ayush, Government of India
申办方类型
Government funding agency

研究点 (1)

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