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A clinical trial to study the effects of Nutrition Powder in children with severe and moderate acute malnutrition

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Non-comparator study to assess the efficacy and safety of AshwaVita Nutrition Powder in participants (children age between 1 to 15 years) with uncomplicated severe and moderate acute malnutrition - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/12/078456
Enrollment
150
Registered
2024-12-23
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Health Condition 1: E40-E46- Malnutrition

Interventions

Intervention1: AshwaVita Powder: About 5 gm once a day with drinking water for 12 weeks Control Intervention1: Placebo Powder: About 5 gm once a day with drinking water for 12 weeks

Sponsors

Rediskovar Innovative Products LLP
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Child with Moderate or Severe Acute Malnutrition Child parent/legal representative willing to give a voluntary written informed consent and agree to come for regular follow up Child assent (verbal oral or written as applicable)

Exclusion criteria

Exclusion criteria: Child having other acute and chronic systemic illnesses or requiring emergency management Child has a known hypersensitivity to any of the study drugs or excipients Child with developmental disorders like cerebral palsy or intellectual disability Child with an inborn error of metabolism, congenital abnormalities Child with a known history or present condition of allergic response to milk or any other ingredient of the formulation Child with neurobehavioral disorders like ADHD autism

Design outcomes

Primary

MeasureTime frame
Assessment of change in Mid Upper Arm Circumference from baseline value Assessment of change in weight-for-height Z score (as applicable) Assessment of change in weight from baseline weightTimepoint: Week 12

Secondary

MeasureTime frame
Assessment of change in BMI from baseline value Assessment of change in weight-for-age Z score (as applicable) at week 12 Adverse eventsTimepoint: Week 12

Countries

India

Contacts

Public ContactPrakash Patel

Sardar Children Hospital

drmaheshjrathod28@gmail.com9825616043

Outcome results

None listed

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