I-FALMIN Albumin Supplement for Patients With Pulmonary Tuberculosis

NCT07186478 | Active Not Recruiting DMC

• 3 other identifiers: UNHAS-TB-CLINTRIAL-2025669/UN4.6.4.5.31./ PP36 / 2024RG.02.05.42.423.01.8.2024.1450
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Pulmonary Tuberculosis; Hypoalbuminemia

Keywords

Pulmonary Tuberculosis; Tuberculosis; Albumin supplement; Hypoalbuminemia; Toman Fish (Channa micropeltes); Phytopharmaceutical; I-FALMIN

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Day 0, Day 15, Day 29, Day 43, and Day 57

Secondary Outcomes (1)

• Proportion of participants with improved chest X-ray findings

  baseline day 0 and End of Study day 57

Study Arms (2)

Experimental: Investigational Drug

EXPERIMENTAL

Participants will receive the investigational drug according to the study protocol.

Drug: Investigational Drug

Placebo Comparator: Placebo

PLACEBO COMPARATOR

Participants will receive placebo identical in appearance to the investigational drug.

Drug: Placebo

Interventions

Investigational Drug 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.

Also known as: IFALMIN (standardized extract from channa micropeltes)

Experimental: Investigational Drug

Placebo DRUG

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

Placebo Comparator: Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hasanuddin University: lead
• RSUP Dr. Wahidin Sudirohusodo: collaborator

Study Sites (1)

RSUD Wahidin Sudirohusodo

Makassar, South Sulawesi, 90245, Indonesia

Location

MeSH Terms

Conditions

Tuberculosis, Pulmonary; Hypoalbuminemia; Tuberculosis

Interventions

Drugs, Investigational; Starch

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Hypoproteinemia; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Both participants and investigators are blinded to group allocation. The placebo is designed to be indistinguishable in appearance, taste, and packaging from the Ifalmin supplement
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Department of Microbiology, Faculty of Medicine, Hasanuddin University

Model Details: Participants with pulmonary tuberculosis will be randomly assigned to two parallel groups. The intervention group will receive standard anti-tuberculosis therapy plus I-FALMIN supplementation, while the control group will receive standard anti-tuberculosis therapy plus a placebo designed to resemble I-FALMIN. Outcomes will be compared between the two groups.

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 22, 2025
• Study Start: December 17, 2024
• Primary Completion: October 20, 2025
• Study Completion: October 20, 2025
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)