NCT07186478

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (estimated)
• Sponsor: Hasanuddin University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

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 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.

Conditions

• Pulmonary Tuberculosis
• Hypoalbuminemia

Interventions

Type	Name	Description
DRUG	Investigational Drug	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.
DRUG	Placebo	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.

Timeline

• Start date: 2024-12-17
• Primary completion: 2025-10-20
• Completion: 2025-10-20
• First posted: 2025-09-22
• Last updated: 2025-09-22

Locations

1 site across 1 country: Indonesia