The Potential Development of I-FALMIN as a Phytopharmaca Candidate for Albumin Supplementation Derived From Toman Fish in Patients With Pulmonary Tuberculosis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Change in serum albumin concentration (g/dL)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
- •Willing to comply with the study protocol by signing informed consent.
排除标准
- •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.
研究组 & 干预措施
Experimental: Investigational Drug
Participants will receive the investigational drug according to the study protocol.
干预措施: Investigational Drug (Drug)
Placebo Comparator: Placebo
Participants will receive placebo identical in appearance to the investigational drug.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in serum albumin concentration (g/dL)
时间窗: Day 0 and Day 15
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.
Change in Body Mass Index (kg/m²)
时间窗: Day 0, Day 15, Day 29, Day 43, and Day 57
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.
次要结局
- Proportion of participants with improved chest X-ray findings(baseline day 0 and End of Study day 57)
研究者
Prof. dr. Muh. Nasrum Massi, Ph.D., Sp.MK (K)
Principal Investigator, Department of Microbiology, Faculty of Medicine, Hasanuddin University
Hasanuddin University