None listed
Conditions
Interventions
Intervention1: Racecadotril: 1.5mg/kg/dose, thrice daily for three days.
1.5mg/kg/dose, thrice daily for three days.
1.5mg/kg/dose, thrice daily for three days.
1.5 mg/kg per dose 3 times daily for
Sponsors
DEpt of GI Sciences, CMC
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria: 1. Children above 6 months and below 5 years of age 2. Suffering from acute diarrhea (defined as more than 3 episodes of watery stools in last 24 hours) 3. Hospitalized for the purpose of supervised oral rehydration or intravenous rehydration
Exclusion criteria
Exclusion criteria: Exclusion Criteria: 1. Children older than 5 years 2. Children with severe coexisting disease, including pneumonia, meningitis, or severe malnutrition, severe being defined as Grade III or Grade IV malnutrition IAP Grading 3. Patients with chronic diarrhea?diarrhea of more than 14 days duration 4. Blood and Mucus in stool
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measures are: ? Diarrheal duration ? Severity of diarrhoea Diarrheal duration is defined as time from presentation (first dose of racecadotril) to the last abnormal stool (normal to be defined by the parent on admission), last stool prior to a 12 hour period with a bowel movement. Therefore, children will be followed until the first normal stool, as defined by the patient?s parent on admission Timepoint: time from presentation (first dose of racecadotril) to the last abnormal stool (normal to be defined by the parent on admission), last stool prior to a 12 hour period with a bowel movement | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary out comes are: ? Requirement of oral rehydration in children with diarrhoea receiving racecadotril in addition to oral rehydration and controls receiving oral rehydration alone will be accessed by monitoring the fluid input and output ? Total diarrheal stool output by weight is measured only in male children due to anatomical considerations. The accurate stool weights can be measured in pre-weighed diapers. ? Proportion of children who recover from diarrhea by 24 hours and 48 hours. ? The need for unscheduled intravenous hydration for recurrent severe dehydration. ? Adverse events, if any Timepoint: 24 hours and 48 hours | — |
Countries
India
Contacts
Public ContactDr Anuradha Bose
CMC, Vellore
Outcome results
None listed