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 range

18 Years – 60 Years

Sex

ALL

See this in plain English?

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Pulmonary Tuberculosis trials