Status:
ACTIVE_NOT_RECRUITING
I-FALMIN Albumin Supplement for Patients With Pulmonary Tuberculosis
Lead Sponsor:
Hasanuddin University
Collaborating Sponsors:
RSUP Dr. Wahidin Sudirohusodo
Conditions:
Pulmonary Tuberculosis
Hypoalbuminemia
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief 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 pati...
Detailed Description
ulmonary tuberculosis (TB) remains a major public health problem in Indonesia, with high rates of morbidity and mortality. In addition to lung damage, many TB patients experience low serum albumin lev...
Eligibility Criteria
Inclusion
- 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
- 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 with extrapulmonary involvement or patients currently hospitalized for TB.
- Prior supplementation with albumin.
Key Trial Info
Start Date :
December 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 20 2025
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT07186478
Start Date
December 17 2024
End Date
October 20 2025
Last Update
September 22 2025
Active Locations (1)
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1
RSUD Wahidin Sudirohusodo
Makassar, South Sulawesi, Indonesia, 90245