Sreenivas 2017.
Methods | RCT Length of follow‐up: not reported |
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Participants | Number: 117 Participants were hospitalized but those with severe dehydration were excluded Inclusion criteria: Patients aged between 3 months and 5 years with acute watery diarrhoea with duration fewer than 7 days were selected for the trial. Exclusion criteria: Subjects were excluded if they had persistent vomiting > 3 episodes/h, severe dehydration, or any serious concomitant illness including HIV seropositive status and severe malnutrition, blood in stool, received an antibiotic or any antidiarrhoeal drug within the preceding 48 hours. Missing data: 4 participants |
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Interventions | Group 1: 55 received racecadotril additional to oral rehydration Group 2: 62 received oral rehydration only Racecadotril was given at a dose of 1.5 mg/kg/day 8 hourly. A uniform dose of 20 mg of elemental zinc was given to all children in both the groups. All the subjects were given breastfeeding, milk and soft food in accordance with WHO recommendations that diet be maintained during treatment of diarrhoea to prevent nutritional disturbance. |
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Outcomes |
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Notes | Location: India No funding received |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Simple random sampling was used to randomize the subjects into 2 groups by computer‐generated numbers |
Allocation concealment (selection bias) | Unclear risk | Not mentioned |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No blinding |
Incomplete outcome data (attrition bias) All outcomes | Low risk | The loss to follow‐up was balanced across the 2 groups, with 2/55 lost from the intervention and 2/62 from the control group. Total attrition was less than 20%. |
Selective reporting (reporting bias) | Unclear risk | Registration of the protocol was not mentioned in the article and the trial protocol was not available. |
Other bias | Low risk | No funding from the pharmaceutical industry |
Abbreviations: RCT: randomized controlled trial.