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Recruiting Phase 3 NCT07089329

Efficacy of Striatin in Malnourished Children

Trial Parameters

Condition Severe Acute Malnutrition
Sponsor Universitas Sriwijaya
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 30
Sex ALL
Min Age 12 Months
Max Age 59 Months
Start Date 2025-05-20
Completion 2025-09-30
Interventions
StriatinPlacebo

Brief Summary

This is a double-blind randomized-controlled clinical trial to identify the effect of Striatin (snakehead fish extract) supplementation in increasing body weight, improving acute inflammatory markers and microbiota profiles in children with severe acute malnutrition (SAM) treating with standard nutritional therapy. The main questions to answer are: Does Striatin supplementation effective in increasing body weight and improving acute inflammatory markers in SAM children? What are the adverse events of Striatin supplementation in SAM children? Researchers will compare Striatin supplementation and placebo (a look-alike substance that contains no drug) to identify the increase of body weight, improvement of acute inflammatory markers and microbiota profiles.

Eligibility Criteria

Inclusion Criteria: 1. Severe acute malnutrition (SAM) children based on WHZ and/or MUAC 2. Consents are given by parents/caregivers. Exclusion Criteria: 1. SAM children with malignancy, liver cirrhosis, acute liver failure, severe kidney disorders, acute and chronic infections that attack the liver or other severe infections that require special treatment. 2. Subjects who require special anthropometric examinations (condition such as edema, organomegaly, amputation, cerebral palsy GMFCS \> 2) 3. Children who have history of severe hypersensitivity to snakehead fish and/or cow's milk.

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