Health Condition 1: K529- Noninfective gastroenteritis and colitis, unspecified
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of treatment in both the groups will be compared on following parameters: 1.Proportion of children with total number of loose or watery stools, (Mean + SD) non inferiority margin mean difference of +0.3 stools 2.Percentage of subjects with diarrhoea for more than 5 days with non inferiority margin of 1.1%. Timepoint: 14 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Both the groups will be compared on following parameters: 1. Proportion of subjects having vomiting & other adverse events in each arm of the study population. 2. Proportions of subjects progressing to persistent diarrhoea. 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. Timepoint: 14 days | — |
Countries
India
Contacts
Lady hardinge medical College Delhi