Alcohol-Related Liver DiseasePhase 3NCT07833514
Misocholic Tablets for Non-Viral Elevated Liver Enzymes
A Phase 3 study testing Misocholic Tab and Silymarin (Silybum marianum) in people with Alcohol-Related Liver Disease and Drug-Induced Liver Injury, run by Hanoi Medical University at 1 site in Vietnam.
Trial summary
Elevated liver enzymes are common laboratory abnormalities that may result from alcohol-related liver disease, drug-induced liver injury, or non-alcoholic fatty liver disease (NAFLD). Persistent elevation of liver enzymes may indicate ongoing hepatocellular injury and increase the risk of progressive liver disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol-Related Liver Disease, Drug-Induced Liver Injury, Non-alcoholic Fatty Liver Disease
- What is being tested?
- Misocholic Tab and Silymarin (Silybum marianum)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteVietnam
- Study dates
- 15 Sep 2026to 30 Jul 2027
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older.
- Mild to moderate elevation of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) at screening, defined as ALT and/or AST ≥2 to <5 times the upper limit of normal (ULN) according to the reference range of the study laboratory.
- Elevated liver enzymes primarily associated with one of the following conditions:
- Alcohol-related liver disease (ALD), defined by: History of hazardous alcohol consumption for at least the previous 3 months (average ethanol intake ≥40 g/day for men or ≥20 g/day for women); Elevated ALT and/or AST consistent with hepatocellular liver injury; At least one supportive feature of alcohol-related liver disease (e.g., elevated GGT, AST/ALT ratio ≥1, hepatomegaly, right upper quadrant discomfort, or hepatic steatosis on ultrasonography); No other liver disease considered the primary cause of liver enzyme elevation.
- Drug-induced liver injury (DILI), defined by: Exposure to conventional medications, herbal medicines, traditional medicines, or dietary supplements within 180 days before detection of elevated liver enzymes; A reasonable temporal relationship between exposure and liver enzyme elevation; Hepatocellular or mixed liver injury pattern with predominant ALT/AST elevation; RUCAM score classified as possible or higher; No other liver disease considered the primary cause of liver enzyme elevation.
- Non-alcoholic fatty liver disease (NAFLD), defined by: Evidence of hepatic steatosis on ultrasonography; Elevated ALT and/or AST consistent with hepatocellular liver injury; Alcohol consumption below the diagnostic threshold for alcohol-related liver disease; No other liver disease considered the primary cause of liver enzyme elevation. Willing to comply with study recommendations for management of the underlying cause, including alcohol abstinence or maximal reduction of alcohol intake when appropriate, discontinuation, substitution, or stabilization of suspected hepatotoxic medications or products when clinically feasible, and maintenance of stable background therapy throughout the study.
- Willing to avoid the use of additional hepatoprotective drugs, herbal medicines, or dietary supplements that may significantly affect liver enzyme levels during the study unless medically required.
- Able and willing to provide written informed consent.
Who cannot join
- Evidence or reasonable suspicion of another liver disease that is considered the primary cause of elevated liver enzymes, including:
- Positive hepatitis B surface antigen (HBsAg) or hepatitis C virus infection (anti-HCV or HCV RNA positive);
- Suspected acute viral hepatitis (including hepatitis A or E when clinically indicated);
- Biliary obstruction, gallstones, biliary tract dilation, hepatic or biliary malignancy, or pancreaticobiliary disease identified by imaging;
- Autoimmune liver disease, Wilson disease, hemochromatosis, alpha-1 antitrypsin deficiency, or other chronic liver diseases other than NAFLD.
- Severe liver injury or advanced liver disease, including:
Show all 23Show fewer
- ALT or AST ≥5 × ULN;
- Total bilirubin ≥2 × ULN or clinically significant jaundice;
- INR ≥1.5 (in participants not receiving anticoagulants);
- Serum albumin <30 g/L;
- Platelet count <100 × 10⁹/L;
- Clinical, laboratory, or imaging evidence of advanced cirrhosis or portal hypertension;
- Ascites, hepatic encephalopathy, gastrointestinal bleeding related to portal hypertension, or decompensated cirrhosis;
- Requirement for urgent hospitalization or specialist treatment because of liver disease.
- Predominantly cholestatic liver injury, including ALP ≥2 × ULN or liver injury pattern considered unsuitable for evaluation of hepatocellular enzyme reduction.
- Extrahepatic causes of elevated aminotransferases, including rhabdomyolysis, acute muscle injury, excessive recent exercise, recent myocardial infarction, severe heart failure, congestive hepatopathy, shock, or severe systemic infection.
- Use of hepatoprotective medications, herbal medicines, or dietary supplements that may influence liver enzymes within 4 weeks before screening.
- Inability to discontinue alcohol consumption or stabilize suspected hepatotoxic medications or products during the study.
- Pregnant or breastfeeding women, or women planning pregnancy during the study period.
- Known hypersensitivity to any component of Misocholic Tab.
- Uncontrolled severe medical illness, active malignancy, or any condition that, in the opinion of the investigator, would make participation inappropriate or unsafe.
- Participation in another interventional clinical trial.
- Inability or unwillingness to comply with study procedures, scheduled visits, study medication, or protocol-required assessments.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site
Hanoi Traditional Medicine General Hospital
Hanoi, Hanoi, 10000
Tu Thi Thanh Nguyen, MD PhD, thanhtu@hmu.edu.vn
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Misocholic Film-Coated Tablets in Patients With Non-Viral Elevated Liver Enzymes
Elevated liver enzymes are common laboratory abnormalities that may result from alcohol-related liver disease, drug-induced liver injury, or non-alcoholic fatty liver disease (NAFLD). Persistent elevation of liver enzymes may indicate ongoing hepatocellular injury and increase the risk of progressive liver disease. Current management primarily focuses on treating the underlying cause and providing supportive care, while evidence for effective hepatoprotective therapies remains limited.
This randomized, double-blind, placebo-controlled clinical trial aims to evaluate the efficacy and safety of Misocholic Tab, a film-coated herbal medicine, in adults with mild to moderate elevation of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) associated with alcohol-related liver disease, drug-induced liver injury, or non-alcoholic fatty liver disease. Eligible participants will be randomly assigned in a 1:1 ratio to receive either Misocholic Tab or matching placebo for 30 days. Both groups will receive standard background therapy with silymarin.
The primary objective is to compare the change in serum ALT and AST levels from baseline to Day 30 between the two treatment groups. Secondary objectives include evaluating the proportion of participants whose liver enzyme levels return to the normal range and assessing the safety of Misocholic Tab through clinical evaluation, laboratory testing, and monitoring of adverse events.
Read the detailed description
Elevated liver enzymes are among the most common abnormalities encountered in clinical practice and often reflect hepatocellular injury. Alcohol-related liver disease (ALD), drug-induced liver injury (DILI), and non-alcoholic fatty liver disease (NAFLD) are major causes of elevated serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST). Persistent elevation of liver enzymes may indicate ongoing liver injury and is associated with progression to fibrosis, cirrhosis, or liver failure if the underlying condition is not adequately controlled.
Current management primarily consists of eliminating or controlling the underlying cause, including alcohol abstinence, withdrawal of potentially hepatotoxic medications, lifestyle modification, and supportive treatment. Although several hepatoprotective agents are used in clinical practice, evidence supporting their efficacy remains limited, and additional randomized controlled trials are needed.
Misocholic Tab is a film-coated herbal medicine developed from a traditional formulation containing dried pig bile extract, artichoke extract, garlic powder, and activated charcoal. Preclinical studies have demonstrated favorable safety profiles as well as hepatoprotective, antioxidant, and anti-fibrotic effects in experimental models of alcohol-induced liver injury, drug-induced liver injury, and liver fibrosis. However, clinical evidence regarding its efficacy and safety in patients with elevated liver enzymes is currently limited.
This study is a prospective, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of Misocholic Tab in adult patients with mild to moderate elevation of ALT and/or AST associated with alcohol-related liver disease, drug-induced liver injury, or non-alcoholic fatty liver disease. Eligible participants will be randomly assigned in a 1:1 ratio to receive either Misocholic Tab or matching placebo for 30 days. Both groups will receive background therapy with silymarin according to the study protocol.
The primary efficacy endpoint is the change in serum ALT and AST levels from baseline to Day 30. Secondary endpoints include the absolute and percentage changes in liver enzyme levels, the proportion of participants achieving normalization of liver enzymes, and the assessment of safety through clinical evaluation, laboratory testing, and monitoring of adverse events.
- Conditions
- Alcohol-Related Liver Disease, Drug-Induced Liver Injury, Non-alcoholic Fatty Liver Disease
- Being tested
- Misocholic Tab, Placebo, Silymarin (Silybum marianum)
- Keywords
- Elevated Liver Enzymes, Alanine Aminotransferase, Aspartate Aminotransferase, Alcohol-Related Liver Disease, Drug-Induced Liver Injury, Non-alcoholic Fatty Liver Disease, Hepatoprotection, Herbal Medicine, Misocholic Tab, Silymarin, Randomized Controlled Trial, Double-Blind Method, Placebo-Controlled Trial
- Medical subject headings
- Chemical and Drug Induced Liver Injury, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Misocholic TabDrug
Film-coated herbal medicine containing dried pig bile extract, artichoke extract, garlic powder, and activated charcoal.
PlaceboDrug
Matching placebo identical in appearance, packaging, color, and taste to Misocholic Tab.
Silymarin (Silybum marianum)Drug
Silymarin 150 mg tablet, one tablet orally three times daily after meals for 30 days, administered as background therapy to participants in both treatment groups.
| Study group | Role | What they receive |
|---|---|---|
| Misocholic Tab | Experimental | Participants will receive Misocholic Tab (1 tablet orally, three times daily after meals) for 30 days in addition to background therapy with silymarin. Receives: Drug: Misocholic Tab; Drug: Silymarin (Silybum marianum) |
| Placebo | Placebo comparator | Participants will receive matching placebo (1 tablet orally, three times daily after meals) for 30 days in addition to background therapy with silymarin. Receives: Drug: Placebo; Drug: Silymarin (Silybum marianum) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum ALT and AST levels from baseline to Day 30
Change in serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) concentrations between baseline (Day 0) and the end of treatment (Day 30). The primary efficacy analysis will compare the mean change in ALT and AST levels between the Misocholic Tab group and the placebo group.
Measured: Baseline and Day 30
Secondary outcomes (3)
Percentage change in serum ALT and AST levels
Percentage change in serum ALT and AST concentrations from baseline to Day 30.
Measured: Baseline and Day 30
Normalization of liver enzyme levels
Proportion of participants achieving normalization of serum ALT and/or AST levels at Day 30.
Measured: Day 30
Safety and tolerability
Incidence of adverse events, serious adverse events, treatment discontinuation due to adverse events, and changes in clinical and laboratory safety parameters during the treatment period.
Measured: Baseline to Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start15 Sep 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Alcohol-Related Liver DiseaseStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to one of two parallel treatment groups: Misocholic Tab plus background silymarin therapy or matching placebo plus background silymarin therapy. Participants will remain in their assigned group throughout the 30-day treatment period, with no crossover between groups.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanoi Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Hanoi Traditional Medicine General Hospital, Minh An Pharmaceutical Technology Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07833514
- Sponsor's protocol ID
- MISO-CT-2026-001
- Status last verified
- Jul 2026
- First submitted
- 16 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
European Association for the Study of the Liver. EASL Clinical Practice Guidelines: Drug-induced liver injury. J Hepatol. 2019 Jun;70(6):1222-1261. doi: 10.1016/j.jhep.2019.02.014. Epub 2019 Mar 27.
PubMed 30926241Crabb DW, Im GY, Szabo G, Mellinger JL, Lucey MR. Diagnosis and Treatment of Alcohol-Associated Liver Diseases: 2019 Practice Guidance From the American Association for the Study of Liver Diseases. Hepatology. 2020 Jan;71(1):306-333. doi: 10.1002/hep.30866. No abstract available.
PubMed 31314133Kwo PY, Cohen SM, Lim JK. ACG Clinical Guideline: Evaluation of Abnormal Liver Chemistries. Am J Gastroenterol. 2017 Jan;112(1):18-35. doi: 10.1038/ajg.2016.517. Epub 2016 Dec 20.
PubMed 27995906
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Misocholic Film-Coated Tablets in Patients With Non-Viral Elevated Liver Enzymes
- ClinicalTrials.gov ID
- NCT07833514
- Acronym / sponsor ID
- MISO-CT-2026-001
- Conditions
- Alcohol-Related Liver Disease, Drug-Induced Liver Injury, Non-alcoholic Fatty Liver Disease
- Keywords
- Elevated Liver Enzymes, Alanine Aminotransferase, Aspartate Aminotransferase, Alcohol-Related Liver Disease, Drug-Induced Liver Injury, Non-alcoholic Fatty Liver Disease, Hepatoprotection, Herbal Medicine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hanoi Medical UniversityUniversity, hospital or other
- Collaborators
- Hanoi Traditional Medicine General Hospital, Minh An Pharmaceutical Technology Co., Ltd.
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 22 Sep 2026 (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.
Elevated liver enzymes are common laboratory abnormalities that may result from alcohol-related liver disease, drug-induced liver injury, or non-alcoholic fatty liver disease (NAFLD). Persistent elevation of liver enzymes may indicate ongoing hepatocellular injury and increase the risk of progressive liver disease. Current management primarily focuses on treating the underlying cause and providing supportive care, while evidence for effective hepatoprotective therapies remains limited.
This randomized, double-blind, placebo-controlled clinical trial aims to evaluate the efficacy and safety of Misocholic Tab, a film-coated herbal medicine, in adults with mild to moderate elevation of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) associated with alcohol-related liver disease, drug-induced liver injury, or non-alcoholic fatty liver disease. Eligible participants will be randomly assigned in a 1:1 ratio to receive either Misocholic Tab or matching placebo for 30 days. Both groups will receive standard background therapy with silymarin.
The primary objective is to compare the change in serum ALT and AST levels from baseline to Day 30 between the two treatment groups. Secondary objectives include evaluating the proportion of participants whose liver enzyme levels return to the normal range and assessing the safety of Misocholic Tab through clinical evaluation, laboratory testing, and monitoring of adverse events.
Detailed description
Elevated liver enzymes are among the most common abnormalities encountered in clinical practice and often reflect hepatocellular injury. Alcohol-related liver disease (ALD), drug-induced liver injury (DILI), and non-alcoholic fatty liver disease (NAFLD) are major causes of elevated serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST). Persistent elevation of liver enzymes may indicate ongoing liver injury and is associated with progression to fibrosis, cirrhosis, or liver failure if the underlying condition is not adequately controlled.
Current management primarily consists of eliminating or controlling the underlying cause, including alcohol abstinence, withdrawal of potentially hepatotoxic medications, lifestyle modification, and supportive treatment. Although several hepatoprotective agents are used in clinical practice, evidence supporting their efficacy remains limited, and additional randomized controlled trials are needed.
Misocholic Tab is a film-coated herbal medicine developed from a traditional formulation containing dried pig bile extract, artichoke extract, garlic powder, and activated charcoal. Preclinical studies have demonstrated favorable safety profiles as well as hepatoprotective, antioxidant, and anti-fibrotic effects in experimental models of alcohol-induced liver injury, drug-induced liver injury, and liver fibrosis. However, clinical evidence regarding its efficacy and safety in patients with elevated liver enzymes is currently limited.
This study is a prospective, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of Misocholic Tab in adult patients with mild to moderate elevation of ALT and/or AST associated with alcohol-related liver disease, drug-induced liver injury, or non-alcoholic fatty liver disease. Eligible participants will be randomly assigned in a 1:1 ratio to receive either Misocholic Tab or matching placebo for 30 days. Both groups will receive background therapy with silymarin according to the study protocol.
The primary efficacy endpoint is the change in serum ALT and AST levels from baseline to Day 30. Secondary endpoints include the absolute and percentage changes in liver enzyme levels, the proportion of participants achieving normalization of liver enzymes, and the assessment of safety through clinical evaluation, laboratory testing, and monitoring of adverse events.
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 will be randomly assigned in a 1:1 ratio to one of two parallel treatment groups: Misocholic Tab plus background silymarin therapy or matching placebo plus background silymarin therapy. Participants will remain in their assigned group throughout the 30-day treatment period, with no crossover between groups.
| Arm | Type | Receives |
|---|---|---|
| Misocholic Tab | Experimental | Drug: Misocholic Tab, Drug: Silymarin (Silybum marianum)Participants will receive Misocholic Tab (1 tablet orally, three times daily after meals) for 30 days in addition to background therapy with silymarin. |
| Placebo | Placebo comparator | Drug: Placebo, Drug: Silymarin (Silybum marianum)Participants will receive matching placebo (1 tablet orally, three times daily after meals) for 30 days in addition to background therapy with silymarin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults aged 18 years or older.
- Mild to moderate elevation of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) at screening, defined as ALT and/or AST ≥2 to <5 times the upper limit of normal (ULN) according to the reference range of the study laboratory.
- Elevated liver enzymes primarily associated with one of the following conditions:
- Willing to avoid the use of additional hepatoprotective drugs, herbal medicines, or dietary supplements that may significantly affect liver enzyme levels during the study unless medically required.
- Able and willing to provide written informed consent.
Key exclusion criteria (23 listed)
- Evidence or reasonable suspicion of another liver disease that is considered the primary cause of elevated liver enzymes, including:
- Severe liver injury or advanced liver disease, including:
- Predominantly cholestatic liver injury, including ALP ≥2 × ULN or liver injury pattern considered unsuitable for evaluation of hepatocellular enzyme reduction.
- Extrahepatic causes of elevated aminotransferases, including rhabdomyolysis, acute muscle injury, excessive recent exercise, recent myocardial infarction, severe heart failure, congestive hepatopathy, shock, or severe systemic infection.
- Use of hepatoprotective medications, herbal medicines, or dietary supplements that may influence liver enzymes within 4 weeks before screening.
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 |
|---|---|---|
| Misocholic TabFilm-coated herbal medicine containing dried pig bile extract, artichoke extract, garlic powder, and activated charcoal. | Drug | Misocholic Tab |
| PlaceboMatching placebo identical in appearance, packaging, color, and taste to Misocholic Tab. | Drug | Placebo |
| Silymarin (Silybum marianum)Silymarin 150 mg tablet, one tablet orally three times daily after meals for 30 days, administered as background therapy to participants in both treatment groups. | Drug | Misocholic Tab, Placebo |
Primary outcome
Change in serum ALT and AST levels from baseline to Day 30
Time frame: Baseline and Day 30
Change in serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) concentrations between baseline (Day 0) and the end of treatment (Day 30). The primary efficacy analysis will compare the mean change in ALT and AST levels between the Misocholic Tab group and the placebo group.
3 secondary outcomes
Percentage change in serum ALT and AST levels
Time frame: Baseline and Day 30
Normalization of liver enzyme levels
Time frame: Day 30
Safety and tolerability
Time frame: Baseline to Day 30
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 2026.
- Background: PubMed 30926241European Association for the Study of the Liver. EASL Clinical Practice Guidelines: Drug-induced liver injury. J Hepatol. 2019 Jun;70(6):1222-1261. doi: 10.1016/j.jhep.2019.02.014. Epub 2019 Mar 27.
- Background: PubMed 31314133Crabb DW, Im GY, Szabo G, Mellinger JL, Lucey MR. Diagnosis and Treatment of Alcohol-Associated Liver Diseases: 2019 Practice Guidance From the American Association for the Study of Liver Diseases. Hepatology. 2020 Jan;71(1):306-333. doi: 10.1002/hep.30866. No abstract available.
- Background: PubMed 27995906Kwo PY, Cohen SM, Lim JK. ACG Clinical Guideline: Evaluation of Abnormal Liver Chemistries. Am J Gastroenterol. 2017 Jan;112(1):18-35. doi: 10.1038/ajg.2016.517. Epub 2016 Dec 20.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Misocholic Tab and Silymarin (Silybum marianum) in people with Alcohol-Related Liver Disease and Drug-Induced Liver Injury, run by Hanoi Medical University at 1 site in Vietnam.
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 23 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: opening soon, as of the sponsor's last update on 22 Sep 2026. 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 Vietnam. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Tu Thi Thanh Nguyen, MD PhD (+84 902 031 192, thanhtu@hmu.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum ALT and AST levels from baseline to Day 30 (time frame: Baseline and Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07833514, which also lists 3 linked publications.
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 2026.