Skip to content

Study of beneficial effect of Bio Sun Kids sachets in children with loose stools

Randomized Double Blinded Controlled Trial to Evaluate the Efficacy and Safety of BioSun Kids - In Children with Acute Diarrhea - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/08/056064
Enrollment
100
Registered
2023-08-03
Start date
Unknown
Completion date
Unknown
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K00-K95- Diseases of the digestive system

Interventions

Intervention1: Bio Sun Kids: One sachet two times daily for 7 days. Control Intervention1: Placebo: One sachet two times daily for 7 days.

Sponsors

Tablets India
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children of either sex aged 3months to 5 years suffering from acute diarrhea of rotaviral origin (duration 1. Children with the above symptoms and those excreting stool positive for rotavirus.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Study group arm anticipated to show clinical as well as statistically significant reduction in the following â?? 1.Number of episodes (frequency) of diarrhea in a day 2.Mean duration of diarrhoea (in days) 3.Degree of dehydration 4.Duration & volume of oral rehydration salt [ORS] therapy 5.Duration & volume of intravenous fluid [IVF] therapy.Timepoint: 7 days

Secondary

MeasureTime frame
1. Duration & volume of intravenous fluid [IVF] therapy.Timepoint: 7 days

Countries

India

Contacts

Public ContactDr S Siva Sankar

Chettinad Hospital and Research Institute

arunrmbbs1978@gmail.com9094752000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026