An interventional study of Investigational Drug and Placebo in Pulmonary Tuberculosis and Hypoalbuminemia, sponsored by Hasanuddin University. Active, not recruiting at 1 site in Indonesia. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-22.
Sponsored by Hasanuddin University · Not applicable, Interventional, and Treatment
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.
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 levels due to chronic infection, malnutrition, and systemic inflammation. Hypoalbuminemia in TB patients is associated with slower recovery, poorer treatment outcomes, and a higher risk of complications.
I-FALMIN is a natural supplement derived from toman fish (Channa micropeltes), which is rich in albumin and essential amino acids. Previous preclinical and early clinical studies have suggested that albumin extracted from toman fish has potential benefits in improving nutritional status and accelerating recovery in patients with chronic illnesses. However, there is limited evidence on its clinical effectiveness as an adjunctive therapy in pulmonary TB.
This study is designed to evaluate the safety and efficacy of I-FALMIN as a phytopharmaceutical candidate to support nutritional recovery in TB patients. Participants will continue to receive standard anti-tuberculosis therapy according to national guidelines. In addition, the intervention group will receive I-FALMIN supplementation, while the control group will receive standard therapy without the supplement.
The primary objective is to determine whether I-FALMIN supplementation increases serum albumin levels compared to standard care alone. Secondary objectives include assessing improvements in clinical symptoms, body weight, immune response, and overall treatment outcomes. Findings from this study are expected to provide scientific evidence to support the development of I-FALMIN as a phytopharmaceutical product that may benefit TB patients in Indonesia and potentially in other countries with high TB burden.
339 studies on the registry are indexed under Tuberculosis, Pulmonary; 69 are open to participants now.
This study's planned enrollment of 112 is below the median of 152 across 242 interventional studies indexed under Tuberculosis, Pulmonary.
Browse Tuberculosis, Pulmonary studies →Hasanuddin University is the lead sponsor of 65 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
Participants will receive the investigational drug according to the study protocol.
Drug: Investigational Drug
Participants will receive placebo identical in appearance to the investigational drug.
Drug: Placebo
IFALMIN® is a standardized herbal preparation derived from Channa micropeltes (ikan toman), containing natural albumin. Administered orally in capsule form at a dose of 500 mg, 2-3 times daily, for 1 day.
Also known as: IFALMIN (standardized extract from channa micropeltes)
Placebo capsule containing inert ingredients (such as starch/lactose), identical in appearance, size, and color to IFALMIN® capsule. Administered orally in capsule form at a dose of 500 mg, 2-3 times daily, for 1 day.
Also known as: Starch capsule
Change in serum albumin concentration (g/dL)
Change in serum albumin concentration among participants with baseline albumin \< 3.1 g/dL. Serum albumin will be measured at Day 0 and reassessed at Day 15 to determine improvement.
Time frame: Day 0 and Day 15
Change in Body Mass Index (kg/m²)
Change in BMI (weight in kg/height in m²) from Day 1 measured at day 15, day 29, day 43, and day 57. Weight was measured with calibrated digital scales and height with a stadiometer. Primary analysis compares the mean change from baseline day 0 to day 57.
Time frame: Day 0, Day 15, Day 29, Day 43, and Day 57
Proportion of participants with improved chest X-ray findings
Chest X-rays will be evaluated by blinded radiologists. Improvement is defined as reduction in infiltrates or consolidation compared to baseline.
Time frame: baseline day 0 and End of Study day 57
Plan to share: No — There are no plans to share individual participant data
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Hasanuddin University