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临床试验/CTRI/2024/12/078028
CTRI/2024/12/078028尚未招募3 期

Comparison of Short Duration Zinc Supplementation with Conventional Zinc therapy in Children with Acute Diarrhea; A Quadruple Blind, Randomized Controlled Trial

Patlolla Akhila1 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2024年12月23日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
156
试验地点
1
主要终点
number of episodes of loose stools after treatment

研究概览

简要总结

We are conducting a randomised controlled trial as a part of post graduate thesis programme. Title of the research is "Comparison of Short Duration Zinc Supplementation with Conventional Zinc Therapy in Children with Acute Diarrhea;A Quadruple Blind Randomised Controlled Trial". It is done in the setting of Department of Pediatrics OPD and IPD, AIIMS Mangalagiri. The sample size is 156 participants and duration of study is 18 months.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

入排标准

年龄范围
6.00 Month(s) 至 59.00 Month(s)(—)
性别
All

入选标准

  • children between 6months to 59 months of age who are diagnosed with Acute watery Diarrhea for less than 7 days(Acute watery diarrhea is defined as a change in the consistency of stool leading to loose/liquid stools and/or an increase in the frequency of evacuations to three or more in 24 hours, with or without fever or vomiting lasting 7 days or less.

排除标准

  • Children with persistent diarrhea
  • Children who have undergone prior GI surgery/ history of prolonged nutritional therapy/ who has taken prior zinc therapy in last 6 months
  • Children with comorbidities.

结局指标

主要结局

number of episodes of loose stools after treatment

时间窗: Days 1,2,3,30,60,90 after treament

次要结局

  • Number of episodes of vomiting after treatment(Day 1 ,2,3,30,60,90 after traetment)

研究者

发起方
Patlolla Akhila
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Patlolla Akhila

Junior Resident

研究点 (1)

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