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Effects of Channa Striata Extract on Intestinal Inflammation and Nutritional Status in Malnutritional Toddlers After Albendazole Therapy in South Bangka District

NCT06933862 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2025-04-18

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if intervention with channa striata extract or inbumin forte sachet as a food supplement can improve intestinal damage and nutritional status in malnourished children aged 1.5-5 years. The main questions it aims to answer are:

* Whether there is a change in calprotectin and AAT levels after administration of snakehead fish extract of inbumin forte sachet?
* Whether there is a difference in changes in nutritional status after administration of snakehead fish extract or inbumin forte sachet? Researchers will compare snakehead fish extract or inbumin forte sachet to a placebo (a look-alike substance that contains no drug) to see if snakehead fish extract or inbumin forte sachet works to treat children malnutrition.

Participants will take snakehead fish extract or inbumin forte sachet or placebo every day for 3 months. Researchers will visit study participants every month to check their weight and height and monitor vitamin administration through photos, notes and videos sent every day and records complaints or symptoms that may arise and at the end of 3 months, researchers will collect stool and blood samples and check nutritional status.

Conditions

  • Malnourished Children

Interventions

DIETARY_SUPPLEMENT

Striatin

striation or placebo given for 90 days assigned to striatin

DIETARY_SUPPLEMENT

Placebo

placebo

Sponsors & Collaborators

  • Dexa Medica Group

    collaborator INDUSTRY

  • Indonesia University

    lead OTHER

Principal Investigators

  • Taniawati Supali · Indonesia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
17 Months
Max Age
60 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-15
Primary Completion
2026-03-30
Completion
2026-06-30

Countries

  • Indonesia

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06933862 on ClinicalTrials.gov