Methods | Quasi‐randomized controlled trial Length of follow‐up: not stated |
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Participants | Number: 117 enrolled children Inclusion criteria: outpatients; well‐nourished children aged 24 to 60 months with watery diarrhoea < 2 days duration; mild‐to‐moderate dehydration Exclusion criteria: bloody diarrhoea, chronic illness, previous medications Breastfeeding: not specified |
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Interventions | Intervention group: diosmectite. Dosage 1.5 g thrice a day for 5 days Control group: no medication |
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Outcomes | Duration of diarrhoea (until normal stool consistency) Complications: severe dehydration, severe dysentery, respiratory infection, and anaemia |
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Notes | Location: India Setting: urban Cause of diarrhoea: not specified Source of funding: not specified |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Not truly random; participants selected by serial number. |
Allocation concealment (selection bias) | High risk | Not concealed |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not blinded |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Not blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Intention‐to‐treat analysis. 8 children (7%) were lost to follow‐up and were included in the analysis. |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to permit judgement. No protocol registered. |
Other bias | Low risk | No other biases detected. |