Study of beneficial effect of Bio Sun Kids sachets in children with loose stools
Phase 4
- Conditions
- Health Condition 1: K00-K95- Diseases of the digestive system
- Registration Number
- CTRI/2023/08/056064
- Lead Sponsor
- Tablets India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Children of either sex aged 3months to 5 years suffering from acute diarrhea of rotaviral origin (duration < 3 days)
1. Children with the above symptoms and those excreting stool positive for rotavirus.
Exclusion Criteria
1. Patients with infectious diarrhea other than rotaviral diarrhea.
2. Patients with serum sodium concentration above 155 or below 130 mmol/L.
3. Those with history of malabsorption syndromes.
4. Having respiratory infections / systemic infection.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Study group arm anticipated to show clinical as well as statistically significant reduction in the following â?? <br/ ><br>1.Number of episodes (frequency) of diarrhea in a day <br/ ><br>2.Mean duration of diarrhoea (in days) <br/ ><br>3.Degree of dehydration <br/ ><br>4.Duration & volume of oral rehydration salt [ORS] therapy <br/ ><br>5.Duration & volume of intravenous fluid [IVF] therapy.Timepoint: 7 days
- Secondary Outcome Measures
Name Time Method 1. Duration & volume of intravenous fluid [IVF] therapy.Timepoint: 7 days