Effect of Chinese herbal medicine Goreisan (Wulingsan) on vomiting with acute watery diarrhoea in childre

Completed

Conditions: Acute gastroenteritis with vomiting and diarrhoea
Infections and Infestations
Diarrhoea and gastroenteritis of presumed infectious origin

Registration Number: ISRCTN34440093

Lead Sponsor: The Institute of Child and Mother Health (ICMH) (Bangladesh)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 400

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Time to stopping of vomiting and diarrhoea after giving medicine or placebo during 72 hours of observation<br>2. Frequency of vomiting and diarrhoea after giving medicine or placebo during 72 hours of observation

Secondary Outcome Measures

Name	Time	Method
1. Recovery from dehydration measured by WHO classification of dehydration in children with diarrhoea<br>2. Amount of oral rehydration sachets (ORS) and intravenous fluid used after giving medicine or placebo during 72 hours of observation