A clinical trial to study the effects of two oral rehydration solutions,Low Osmolarity ORS and ReSoMal(Reduced Osmolarity Solution For Malnourished) in children with Severe Acute Malnutrition with diarrhea

A randomized controlled trial to compare the safety and efficacy of low osmolarity ORS versus modified Rehydration Solution for Malnourished children (RESOMAL) for treatment of children with severe acute malnutrition and diarrhea

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/02/003399

Enrollment

110

Registered

2013-02-15

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Children With Severe Acute Malnutrition and Diarrhea

Interventions

Intervention1: Low Osmolarity ORS: Low Osmolarity ORS to be used as oral rehydration solution in children with Severe Acute Malnutrition with diarrhea as per WHO guidelines on oral rehydration, every

Eligibility

Inclusion criteria

Inclusion criteria: Children having acute diarrhea(of Severe Acute Malnutrition defined as weight for height < -3 SD per WHO growth charts and or bilateral pedal edema

Exclusion criteria

Exclusion criteria: Child received I/V fluid before admission Child with shock Child with convulsion or any other life threatening complication Child with known renal or heart disease History of not passed urine for more than 6 hours Electrolyte disturbance requring I/V correction

Design outcomes

Primary

Measure	Time frame
Number of children who develop hyponatremia. (serum sodium less than 135 mmol/litre)Timepoint: 48 hours	—

Secondary

Measure	Time frame
Episodes of vomitingTimepoint: 48 hours;Incidence of fluid overloadTimepoint: 48hrs;Incidence of hypokalemiaTimepoint: 48 hours;Stool frequencyTimepoint: 48 hours	—

Countries

India

Contacts

Public ContactDr Praveen Kumar

Lady Hardinge MedicalCollege

pkpaed@gmail.com09868579672

Outcome results

None listed

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