ovel dose of zinc therapy in childhood diarrhoea: Standard dose vs Low dose
Phase 3
- Conditions
- Health Condition 1: K529- Noninfective gastroenteritis and colitis, unspecified
- Registration Number
- CTRI/2023/09/057259
- Lead Sponsor
- Tanisha Negi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
All children aged 6 months to 59 months of age ;
Presenting with acute diarrhea / dysentry (as per WHO criteria) not longer that 72 hours /3 days before the presentation.
Exclusion Criteria
1.Children identified as SAM as per WHO criteria.18
2.Children undergoing treatment for severe dehydration.
3.Have been treated for measles within past 1 month.
4.Diagnosed cases of severe pneumonia, sepsis and malaria.
5.Known cases of chronic systemic disorders.
6.Has already received zinc supplements in the preceding 3 days before enrolment.
7.Known sensitivity to zinc containing compounds.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy of treatment in both the groups will be compared on following parameters: <br/ ><br>1.Proportion of children with total number of loose or watery stools, (Mean + SD) non inferiority margin mean difference of +0.3 stools <br/ ><br>2.Percentage of subjects with diarrhoea for more than 5 days with non inferiority margin of 1.1%. <br/ ><br>Timepoint: 14 days
- Secondary Outcome Measures
Name Time Method Both the groups will be compared on following parameters: <br/ ><br>1.Proportion of subjects having vomiting & other adverse events in each arm of the study population. <br/ ><br>2.Proportions of subjects progressing to persistent diarrhoea. <br/ ><br>3.Proportion of Moderately Acute Malnourished children (MAM) in both the research arms compared for the efficacy of treatment as defined in primary outcome parameters. <br/ ><br>Timepoint: 14 days