About this trial
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.
Eligibility criteria
Qualifiers
Malnourished children aged 1.5-5 years (-3SD to < -2 SD)
Parents or guardians are willing to participate in the study
Parents or guardians can read and fill out the questionnaire
Disqualifiers
Children with chronic diseases such as tuberculosis, congenital heart disease, diabetes, cancer, epilepsy, HIV Aids, sickle cell anemia, and mental illness.
Children with history of snakehead fish allergy
Children with physical disabilities that complicate data collection
Trial design
Treatments tested in this trial
- Striatin
- Placebo
Treatment groups
Locations
2Map coordinates are unavailable for these locations. Locations are shown below instead.
Sponsors and collaborators
Indonesia University
Lead sponsor
Fakultas Kedokteran Universitas Indonesia
Sponsor institution
Dexa Medica Group
Collaborator