Active — Not RecruitingNot Applicable

I-FALMIN Albumin Supplement for Patients With Pulmonary Tuberculosis

Indonesia112 participantsStarted 2024-12-17

Plain-language summary

This study evaluates the potential of I-FALMIN, a supplement derived from toman fish (Channa micropeltes), as an additional source of albumin in patients with pulmonary tuberculosis. Tuberculosis patients often experience low albumin levels, which may slow down recovery. The purpose of this study is to determine whether giving I-FALMIN as a supplement, in addition to standard tuberculosis treatment, can improve albumin levels and support overall health status. The study will compare outcomes between patients who receive I-FALMIN and those who do not.

Who can participate

Age range18 Years – 60 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult male and female participants aged 18-60 years. * Newly diagnosed tuberculosis (TB) patients based on sputum examination using GeneXpert MTB/RIF with MTB positive (low, moderate, or high) and rifampicin resistance not detected. * Body Mass Index (BMI), calculated as weight in kilograms divided by height in meters squared (kg/m²), categorized according to WHO: \<18.5 underweight, 18.5-24.9 normal. Eligible participants are those with BMI below the lower normal threshold (\<22.5). * Will receive standard anti-tuberculosis treatment (OAT) regimen (4FDC) according to body weight. * Serum albumin level \<3.5 g/dL before initiation of treatment. * Willing to undergo randomization and receive the investigational product for 14 days (3 × 4 tablets daily). * Willing to undergo scheduled follow-up visits at the hospital (clinical examination, BMI measurement, sputum, and blood sampling) on days 15, 29, 43, and 57, as well as sputum smear examination on day 15 and day 57. * Willing to comply with the study protocol by signing informed consent. Exclusion Criteria: * Confirmed HIV infection. * Pregnant or breastfeeding women. * History of drug allergy. * Comorbid hepatitis. * Complicated liver cirrhosis. * Nephrotic syndrome. * History of hematemesis (vomiting blood). * Renal failure. * Burn injury. * Gastric disorders or intestinal diseases. * Malignancy (cancer). * Cardiac disorders. * History of stroke. * Allergy to fish protein. * Pulmonary tuberculosis w…

What they're measuring

Change in serum albumin concentration (g/dL)

Timeframe: Day 0 and Day 15

Change in Body Mass Index (kg/m²)

Timeframe: Day 0, Day 15, Day 29, Day 43, and Day 57

Trial details

NCT IDNCT07186478

SponsorHasanuddin University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-20