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To compare flavored vs regular WHO ORS in children with acute diarrhea

Flavored vs Regular WHO Oral Rehydration Salt (ORS) Solution for treatment of dehydration in children with Acute diarrhea: A randomized controlled study - nil

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/092153
Enrollment
112
Registered
2025-08-01
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Health Condition 1: A09- Infectious gastroenteritis and colitis, unspecified

Interventions

Intervention1: Flavored ORS: 75 ml/kg orange flavor in powdered formulation Intervention2: Flavored ORS: 75 ml/kg over 4 hours in orange flavor with powdered formulation Control Intervention1: Regular

Sponsors

Intramural Research Grant Institute
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children aged (3 months to 5 years) reporting to the Department of Pediatrics (Outpatient department or Emergency services) with acute diarrhea (duration less than 7days) and some dehydration (as per WHO criteria)

Exclusion criteria

Exclusion criteria: Children with 1 Severe acute malnutrition (as per WHO criteria) 2 Blood in stools at enrolment 3 Conditions associated with edema ( example nephrotic syndrome and congestive heart failure) 4 History or examination findings suggestive of acute severe comorbidities (example sepsis or shock or severe pneumonia) requiring intravenous fluid therapy 5 Known (or findings suggestive of) chronic comorbidities (e.g. CKD or Hemolytic anemias or CLD)

Design outcomes

Primary

MeasureTime frame
Volume (mL/kg) of ORS solution consumed during 4 hours of rehydration.Timepoint: during 4 hours of rehydration.

Secondary

MeasureTime frame
Proportion of successfully rehydrated children which will be defined as having no dehydration at 4 hours of ORT Proportion of children requiring intravenous fluids Frequency of vomiting and loose stools Dehydration scores Caregiver satisfaction measured on a Likert scale Microbiological profile of stool sample Timepoint: 4 hours

Countries

India

Contacts

Public ContactDr Minal Rastogi

University college of medical sciences

minalr723@gmail.com9540558433

Outcome results

None listed

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