Pulmonary TuberculosisI-FALMIN TBNCT07186478
I-FALMIN Albumin Supplement for Patients With Pulmonary Tuberculosis
A study testing Investigational Drug in people with Pulmonary Tuberculosis and Hypoalbuminemia, run by Hasanuddin University at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Tuberculosis, Hypoalbuminemia
- What is being tested?
- Investigational Drug
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteIndonesia
- Study dates
- 17 Dec 2024to 20 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Confirmed HIV infection.
- Pregnant or breastfeeding women.
- History of drug allergy.
- Comorbid hepatitis.
- Complicated liver cirrhosis.
- Nephrotic syndrome.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Potential Development of I-FALMIN as a Phytopharmaca Candidate for Albumin Supplementation Derived From Toman Fish in Patients With Pulmonary Tuberculosis
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.
Read the 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
- Being tested
- Investigational Drug, Placebo
- Keywords
- Pulmonary Tuberculosis, Tuberculosis, Albumin supplement, Hypoalbuminemia, Toman Fish (Channa micropeltes), Phytopharmaceutical, I-FALMIN
- Medical subject headings
- Tuberculosis, Pulmonary, Hypoalbuminemia, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational DrugDrug
Also called IFALMIN (standardized extract from channa micropeltes)
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.
PlaceboDrug
Also called Starch capsule
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Investigational Drug | Experimental | Participants will receive the investigational drug according to the study protocol. Receives: Drug: Investigational Drug |
| Placebo Comparator: Placebo | Placebo comparator | Participants will receive placebo identical in appearance to the investigational drug. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 0, Day 15, Day 29, Day 43, and Day 57
Secondary outcomes (1)
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.
Measured: baseline day 0 and End of Study day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start17 Dec 2024
- Primary completion20 Oct 2025 (estimated)
- Study completion20 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasanuddin University
- Sponsor type
- University, hospital or other
- Collaborators
- RSUP Dr. Wahidin Sudirohusodo
- Responsible party
- Principal investigator, Prof. dr. Muh. Nasrum Massi, Ph.D., Sp.MK (K), Hasanuddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07186478
- Sponsor's protocol ID
- UNHAS-TB-CLINTRIAL-2025
- Other IDs
- 669/UN4.6.4.5.31./ PP36 / 2024, RG.02.05.42.423.01.8.2024.1450
- Acronym
- I-FALMIN TB
- Status last verified
- Sep 2025
- First submitted
- 9 Sep 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to share individual participant data
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Potential Development of I-FALMIN as a Phytopharmaca Candidate for Albumin Supplementation Derived From Toman Fish in Patients With Pulmonary Tuberculosis
- ClinicalTrials.gov ID
- NCT07186478
- Acronym / sponsor ID
- I-FALMIN TB / UNHAS-TB-CLINTRIAL-2025
- Conditions
- Pulmonary Tuberculosis, Hypoalbuminemia
- Keywords
- Pulmonary Tuberculosis, Tuberculosis, Albumin supplement, Hypoalbuminemia, Toman Fish (Channa micropeltes), Phytopharmaceutical, I-FALMIN
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Hasanuddin UniversityUniversity, hospital or other
- Collaborators
- RSUP Dr. Wahidin Sudirohusodo
- Study start
- 17 Dec 2024 (actual)
- Primary completion
- 20 Oct 2025 (estimated)
- Study completion
- 20 Oct 2025 (estimated)
- First posted
- 22 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Investigational Drug | Experimental | Drug: Investigational DrugParticipants will receive the investigational drug according to the study protocol. |
| Placebo Comparator: Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo identical in appearance to the investigational drug. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (16 listed)
- Confirmed HIV infection.
- Pregnant or breastfeeding women.
- History of drug allergy.
- Comorbid hepatitis.
- Complicated liver cirrhosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Investigational DrugAlso: IFALMIN (standardized extract from channa micropeltes)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 | Experimental: Investigational Drug |
| PlaceboAlso: Starch capsulePlacebo 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. | Drug | Placebo Comparator: Placebo |
Primary outcome
Change in serum albumin concentration (g/dL)
Time frame: 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)
Time frame: 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.
1 secondary outcome
Proportion of participants with improved chest X-ray findings
Time frame: baseline day 0 and End of Study day 57
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Individual participant dataSharing planned: No. There are no plans to share individual participant data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational Drug in people with Pulmonary Tuberculosis and Hypoalbuminemia, run by Hasanuddin University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum albumin concentration (g/dL) (time frame: Day 0 and Day 15). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.