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Toman fish supplement tested to boost albumin in TB patients

NCT ID NCT07186478

Disease control Sponsor: Hasanuddin University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests I-FALMIN, a supplement made from toman fish, in 112 adults with pulmonary tuberculosis and low albumin levels. Participants take the supplement or a placebo for one day alongside standard TB treatment. Researchers will check if albumin levels and body mass index improve over 57 days, aiming to see if this natural supplement can aid recovery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
I-FALMIN (standardized extract from toman fish, containing natural albumin)
What this could lead to
If it works, this could provide a natural, affordable supplement to improve albumin levels and recovery in tuberculosis patients.
What could go wrong
This is an early-stage trial with only 112 participants, so results may not apply broadly. The supplement is tested for just one day, and long-term benefits or risks are unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 112 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Oct 2025

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

Hypoalbuminemia pulmonary tuberculosis tuberculosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypoalbuminemia Pulmonary tuberculosis

Contacts and locations

Locations

  • RSUD Wahidin Sudirohusodo

    Makassar, South Sulawesi, 90245, Indonesia

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