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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age17-60
SponsorIndonesia University

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

122 Participants
are divided into 2 treatment groups

Locations

2

Map coordinates are unavailable for these locations. Locations are shown below instead.

Indonesian territories Status unavailable 33783, South Bangka Or Toboali, Bangka–Belitung IslandsIndonesiaIndonesia
IMERI Faculty of Medicine Universitas Indonesia Status unavailable 10430, Central Jakarta, DKI JakartaIndonesiaIndonesia

Sponsors and collaborators

Indonesia University

Lead sponsor

Fakultas Kedokteran Universitas Indonesia

Sponsor institution

Dexa Medica Group

Collaborator