Acute gastroenteritis with vomiting and diarrhoea Infections and Infestations Diarrhoea and gastroenteritis of presumed infectious origin
Conditions
Interventions
Subjects will be stratified by sex and randomised to Goreisan (Wulingsan) powder or placebo orally in a dose of 0.25 g/kg/day (maximum of 6.0 g/day) twice a day for 3 days.
Contact details for joint
Sponsors
The Institute of Child and Mother Health (ICMH) (Bangladesh)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged six months up to five completed years, either sex 2. Within 3 days onset of vomiting and watery diarrhoea before enrolment 3. Cases of diarrhoea fulfilling World Health Organization (WHO) criteria (loose motion 3 times and over within 24 hours) 4. Patients with diarrhoea who are still vomiting or have at least one episode of spontaneous vomiting within 3 hours before enrolment
Exclusion criteria
Exclusion criteria: 1. Severe dehydration (WHO 2003) needing immediate intravenous fluid 2. Bloody diarrhoea 3. Anti-emetics used during this illness 4. Patients with diarrhoea and severe malnutrition 5. Any signs suggesting bacterial infections that need immediate antibiotic therapy 6. Any signs suggesting meningitis 7. Any signs suggesting ileus and/or intussusception 8. Any signs of serious systemic illness 9. Underlying congenital gastrointestinal disease 10. Other severe underlying diseases (i.e., cancer, acquired immune deficiency syndrome [AIDS], other immuno-compromised patients) 11. Past history of hospitalisation due to severe anaphylaxis to any kinds of foods or liquids
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Time to stopping of vomiting and diarrhoea after giving medicine or placebo during 72 hours of observation 2. Frequency of vomiting and diarrhoea after giving medicine or placebo during 72 hours of observation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Recovery from dehydration measured by WHO classification of dehydration in children with diarrhoea 2. Amount of oral rehydration sachets (ORS) and intravenous fluid used after giving medicine or placebo during 72 hours of observation | — |
Countries
Bangladesh
Outcome results
None listed