Kang 2016b.

Methods	Randomized, double‐blinded, placebo‐controlled trial Length of follow‐up: not reported
Participants	Number: 199 Inclusion criteria: Children aged 3 to 59 months with acute diarrhoea (≥ 3 episodes of loose, watery stools in last 24 hours for less than 3 days); the trial physician recommended management of diarrhoea at home. Exclusion criteria: Children with weight less than 5 kg, with severe co‐existing diseases, severe malnutrition, chronic diarrhoea, or with blood and mucus in stool. Children received antibiotics, probiotics, probiotics, steroids, herbal medicines, antiemetics, anti‐motility or other treatment of unknown nature. Missing data: 3 patients
Interventions	Group 1: 102 children received racecadotril additional to WHO standard of care. Group 2: 97 children received placebo additional to WHO standard of care.
Outcomes	Median duration of diarrhoea. Defined as the time from onset of diarrhoea to the time of resolution, identified as the time of the last abnormal stool or the start of a 12‐hour period with no stool. This was recorded by a trial nurse in the hospital and by mother’s recall during the field worker’s visit in the community‐based trial. Presence of vomiting after administering the drug or placebo. History of day care or hospital visit, or both, during the period of observation.
Notes	Location: India Source of funding: Swedish International Development Agency (governmental organization)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Individual randomization codes were generated by a statistician not associated with this trial
Allocation concealment (selection bias)	Low risk	Sealed envelopes with randomization codes were given directly to the hospital pharmacy
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Double‐blinded. The hospital pharmacy provided identically packed trial drug or placebo
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Double‐blinded placebo‐controlled
Incomplete outcome data (attrition bias) All outcomes	Low risk	The loss to follow‐up was balanced across the 2 groups, with 3/102 lost from the intervention and 0/97 from the control group. The total amount of attrition was less than 20%
Selective reporting (reporting bias)	Low risk	The trial was registered and all important outcomes were reported
Other bias	Low risk	Not funded by pharmaceutical industry