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NOT YET RECRUITING
NCT06933862
NA

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

Sponsor: Indonesia University

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

17 Months - 60 Months

Study Type

INTERVENTIONAL

Enrollment

122

Start Date

2025-05-15

Completion Date

2026-06-30

Last Updated

2025-04-18

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Striatin

striation or placebo given for 90 days assigned to striatin

DIETARY_SUPPLEMENT

Placebo

placebo

Locations (2)

Indonesian territories

South Bangka Or Toboali, Bangka–Belitung Islands, Indonesia

IMERI Faculty of Medicine Universitas Indonesia

Central Jakarta, DKI Jakarta, Indonesia