NCT07186478Active, not recruiting
I-FALMIN Albumin Supplement for Patients With Pulmonary Tuberculosis
The Potential Development of I-FALMIN as a Phytopharmaca Candidate for Albumin Supplementation Derived From Toman Fish in Patients With Pulmonary Tuberculosis
Source: ClinicalTrials.gov · Last updated 22 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 112 (estimated)
- First submitted
- 9 Sept 2025
- Start date
- 17 Dec 2024
- Primary completion date
- 20 Oct 2025
- Lead sponsor
- Hasanuddin University
- Diseases
- Tuberculosis
- NCT number
- NCT07186478
What you commit to
- Study type: Interventional
- Planned participants: 112
- From 17 Dec 2024 to the primary completion date, 20 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Confirmed HIV infection.
- History of drug allergy.
- Comorbid hepatitis.
- Nephrotic syndrome.
- History of hematemesis (vomiting blood).
- Renal failure.
- 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.
Lab values
- Prior supplementation with albumin.
Other
- Pregnant or breastfeeding women.
- Complicated liver cirrhosis.
- Burn injury.
Who the study is looking for
- 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.
Age in the registry: 18 years to 60 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| RSUD Wahidin Sudirohusodo Coordinator of this site? Confirm its status | Makassar | Indonesia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.