Comprehensive studies of a new improved oral rehydration solution for diarrhoeal disease: physiological and molecular studies, clinical trials, and acceptability and efficacy studies in a rural south Indian community
- Conditions
- DiarrhoeaSigns and Symptoms
- Registration Number
- ISRCTN72841333
- Lead Sponsor
- Christian Medical College (India)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
In the adult study, all adult male patients presenting to the Emergency Service with acute severe watery diarrhoea of less than three days' duration, with moderate to severe dehydration, will be enrolled after informed written consent.
In a separate trial, male children aged six months to five years with diarrhoea (defined as more than three watery stools/24 hours) of three days or less, with mild or moderate dehydration, or those with severe dehydration who have received intravenous rehydration, will be enrolled after informed written consent from the parent.
In the adult trial, subjects without clinical dehydration, those with presence of blood in stool, and presence of significant systemic illness unrelated to the diarrhoea, will be excluded.
In the children's trial, bloody diarrhoea, concurrent severe illness (such as pneumonia, meningitis or infections requiring antibiotics), and severe malnutrition Grade III and IV will be treated as exclusion criteria.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Stool weight in successive 12 hour periods<br>2. Stool weight in the second 24 hours<br>3. Time to last unformed stool<br>4. Requirement for unscheduled intravenous fluids
- Secondary Outcome Measures
Name Time Method o secondary outcome measures