Drug Induced Liver InjuryNCT06922669
Glucocorticoids for Acute Drug Induced Liver Injury With Hyperbilirubinemia
A study testing Methylprednisolone, Magnesium isoglycyrrhizinate and Glutathione in people with Drug Induced Liver Injury, run by General Hospital of Shenyang Military Region at 1 site in China.
Trial summary
Drug-induced liver injury (DILI) can lead to potentially fatal complications, such as acute liver failure and even death. In clinical practice, glucocorticoids have been considered in some cases of DILI, especially patients with hyperbilirubinemia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Drug Induced Liver Injury
- What is being tested?
- Methylprednisolone, Magnesium isoglycyrrhizinate and Glutathione
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 1 siteChina
- Study dates
- 24 Jun 2025to 30 Sep 2027
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A definite diagnosis of acute DILI;
- 5×ULN ≤ TBIL level at baseline ≤ 20×ULN;
- Age 18-80 years old;
- Sign the informed consent form.
Who cannot join
- Other causes of liver injury, including viral hepatitis, cytomegalovirus infection, Epstein-Barr virus infection, Herpes virus infection, autoimmune liver disease, alcoholic liver disease, hypoxic/ischemic liver disease, Budd-Chiari syndrome, biliary tract disease, Wilson's disease, hemochromatosis, and α1-antitrypsin deficiency;
- Immune checkpoint inhibitors or gynura segetum induced DILI;
- Absolute contraindications to glucocorticoids, such as systemic mold infections or allergies;
- A history of glucocorticoid therapy within 3 months before enrollment;
- A history of diseases requiring glucocorticoid maintenance therapy, such as rheumatoid arthritis, systemic lupus erythematosus, systemic dermatomyositis, etc;
- A history of liver transplantation;
Show all 18Show fewer
- Received artificial liver therapy before enrollment;
- Malignant tumor of the liver, bile duct, pancreas or liver metastasis
- Acute liver failure;
- Renal dysfunction, creatinine Cr≥133μmol/L;
- Neutrophil count <1,000,000,000/L;
- Active tuberculosis;
- Severe cardiopulmonary diseases;
- Recent surgery or trauma;
- Mental illness;
- Pregnancy or lactation;
- Participated in other clinical studies within 3 months before enrollment;
- Other conditions judged by the clinician to be inappropriate for study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)
Shenyang, Liaoning, 110840
Xingshun Qi, 18909881019, xingshunqi@126.com
Qianqian Li, 13940307473, 1208594776@qq.com
About this study
Official title: Efficacy and Safety of Glucocorticoids for Acute Drug Induced Liver Injury With Hyperbilirubinemia: A Multicenter Randomized Controlled Trial
Drug-induced liver injury (DILI) can lead to potentially fatal complications, such as acute liver failure and even death. In clinical practice, glucocorticoids have been considered in some cases of DILI, especially patients with hyperbilirubinemia. However, the available evidence remains controversial and its quality is also very limited. Herein, a multicenter randomized controlled trial (RCT) has been designed to explore the efficacy and safety of glucocorticoids in patients with acute DILI and hyperbilirubinemia.
Read the detailed description
Overall, 232 patients with acute DILI with hyperbilirubinemia will be enrolled. They will be randomly assigned at a ratio of 1:1 to the conventional treatment alone or combined with glucocorticoids groups. The primary endpoint is the improvement of DILI after treatment on second week. Secondary endpoints include the improvement of DILI on fourth week, rates of progressive liver injury, liver failure, liver transplantation, survival, and adverse events. Exploratory endpoints will assess the beneficial population and changes of inflammatory factors following glucocorticoid treatment.
- Conditions
- Drug Induced Liver Injury
- Being tested
- Methylprednisolone, Magnesium isoglycyrrhizinate, Glutathione, Silymarin, Polyene Phosphatidylcholine
- Keywords
- Drug induced liver injury, liver failure, glucocorticoids, clinical trial, Hyperbilirubinemia
- Medical subject headings
- Chemical and Drug Induced Liver Injury, Liver Failure, Hyperbilirubinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Medrol
Initially, an intravenous dose of 1 mg/kg/day of methylprednisolone will be administered for one week, with the possibility of extending treatment to two weeks if necessary. Following this, participants will receive oral methylprednisolone tablets, starting at a dose of 40 mg/day. The oral dosage will be gradually tapered based on the participants' condition over a period of 1 to 3 months.
Magnesium isoglycyrrhizinateDrug
It is suitable for patients with hepatocellular or mixed DILI. A daily dose of 0.15g to 0.2g
GlutathioneDrug
It is suitable for patients with hepatocellular or mixed DILI. A daily dose of 1.2g to 1.8g
SilymarinDrug
Also called Legalon
It is suitable for patients with hepatocellular or mixed DILI. The dosage is 140 mg, taken 2 to 3 times per day.
Polyene PhosphatidylcholineDrug
Also called Essentiale
It is suitable for patients with hepatocellular or mixed DILI. The dosage is 228mg-456mg, taken 3 times per day.
Ursodeoxycholic acid capsulesDrug
Also called Ursofalk
It is suitable for patients with cholestatic or mixed DILI. A daily dose of 10mg-15mg/kg/day.
Ademetionine 1,4-ButanedisulfonateDrug
Also called Transmeti
It is suitable for patients with cholestatic or mixed DILI. A daily dose of 0.5g to 1g.
Plaslna exchangeProcedure or surgery
Also called Artificial liver support
It is suitable for patients whose condition continues to worsen or even develop to liver failure.
Liver transplantationProcedure or surgery
It is suitable for patients whose condition continues to worsen or even develop to liver failure.
| Study group | Role | What they receive |
|---|---|---|
| Glucocorticoids group | Experimental | Glucocorticoids step-down therapy combined with conventional treatment. Receives: Drug: Methylprednisolone; Drug: Magnesium isoglycyrrhizinate; Drug: Glutathione; Drug: Silymarin; Drug: Polyene Phosphatidylcholine; Drug: Ursodeoxycholic acid capsules; Drug: Ademetionine 1,4-Butanedisulfonate; Procedure: Plaslna exchange; Procedure: Liver transplantation |
| Conventional treatment | Active comparator | Only conventional treatment according to the Chinese practice guidelines regarding the management of DILI. Receives: Drug: Magnesium isoglycyrrhizinate; Drug: Glutathione; Drug: Silymarin; Drug: Polyene Phosphatidylcholine; Drug: Ursodeoxycholic acid capsules; Drug: Ademetionine 1,4-Butanedisulfonate; Procedure: Plaslna exchange; Procedure: Liver transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of DILI on the second week
TBIL level decreases by 50% as compared to the baseline level.
Measured: 2 weeks
Secondary outcomes (9)
Improvement of DILI on the fourth week
TBIL level decreases by 50% as compared to the baseline level.
Measured: 4 weeks
Progressive liver injury on the second week
TBIL level increases as compared to the baseline level.
Measured: 2 weeks
Progressive liver injury on the fourth week
TBIL level increases as compared to the baseline level.
Measured: 4 weeks
Improvement of liver enzymes on the second week
Proportion of 50% reduction from baseline in ALT, AST, ALP, and GGT levels.
Measured: 2 weeks
Improvement of liver enzymes on the fourth week
Proportion of 50% reduction from baseline in ALT, AST, ALP, and GGT levels.
Measured: 4 weeks
Liver failure
Participants develop overt hepatic encephalopathy with an INR of ≥1.5.
Measured: 3 months
Liver transplantation
Participants undergo liver transplantation due to liver failure.
Measured: 3 months
Survival
All participants will be followed by telephone to record survival status, including the major cause and date of death.
Measured: 3 months
Adverse events
Adverse events related to glucocorticoids mainly include infection, water-sodium retention, Cushing syndrome, poor glycemic, gastrointestinal ulcer, thromboembolic disease, neuropsychiatric symptoms, osteoporosis, increased intraocular pressure, and withdrawal syndrome. They will be closely recorded during the period of glucocorticoids treatment.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start24 Jun 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Drug Induced Liver InjuryStudies 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
- Masking
- None (open label)
- Enrolment
- 232 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Shenyang Military Region
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xingshun Qi, General Hospital of Shenyang Military Region
- Investigators
- Xingshun Qi, Principal investigator, Department of Gastroenterology, General Hospital of Northern Theater CommandWeifen Xie, Principal investigator, Shanghai Changzheng HospitalXin Zeng, Principal investigator, Shanghai East Hospital of Tongji UniversityLu Zhou, Principal investigator, General Hospital, Tianjin Medical UniversityFengmei Wang, Principal investigator, Tianjin First Central HospitalQing Ye, Principal investigator, Tianjin Third Central HospitalYanjing Gao, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06922669
- Sponsor's protocol ID
- XHNKKY-ASDILI-RCT
- Status last verified
- Dec 2025
- First submitted
- 3 Apr 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hou FQ, Zeng Z, Wang GQ. Hospital admissions for drug-induced liver injury: clinical features, therapy, and outcomes. Cell Biochem Biophys. 2012 Nov;64(2):77-83. doi: 10.1007/s12013-012-9373-y.
PubMed 22806342Hu PF, Wang PQ, Chen H, Hu XF, Xie QP, Shi J, Lin L, Xie WF. Beneficial effect of corticosteroids for patients with severe drug-induced liver injury. J Dig Dis. 2016 Sep;17(9):618-627. doi: 10.1111/1751-2980.12383.
PubMed 27426618Chai L, Wang R, Teschke R, Jin S, Deng J, Qi X. Successful corticosteroid therapy for severe liver injury secondary to herbal traditional Chinese medicine, Mega Defends X, assessed for causality by the updated RUCAM: A case report. Medicine (Baltimore). 2024 Aug 23;103(34):e39439. doi: 10.1097/MD.0000000000039439.
PubMed 39183394Mao Y, Ma S, Liu C, Liu X, Su M, Li D, Li Y, Chen G, Chen J, Chen J, Zhao J, Guo X, Tang J, Zhuge Y, Xie Q, Xie W, Lai R, Cai D, Cai Q, Zhi Y, Li X; Technology Committee on DILI Prevention, Management, Chinese Medical Biotechnology Association; Study Group on Drug-Induced Liver Disease, Chinese Society of Hepatology, Chinese Medical Association. Chinese guideline for the diagnosis and treatment of drug-induced liver injury: an update. Hepatol Int. 2024 Apr;18(2):384-419. doi: 10.1007/s12072-023-10633-7. Epub 2024 Feb 24.
PubMed 38402364Li Q, Lin Y, Zeng X, Zhou L, Wang F, Ye Q, Gao Y, Guo L, Zhu J, Li J, Li Y, Shao L, Hu Y, Xiao J, Jia A, Wang D, Chang L, Wang J, Zhang J, Wang R, Gao F, Wu Q, Hu P, Zhu C, Cai L, Ran Y, Li Y, Zhang J, Ran Y, Wang C, Wang N, Zhang J, Zhang X, Li J, Sun J, Chu Y, Ma Y, Wang T, Zheng Z, Shen Y, Qi X, Xie W. Efficacy and safety of glucocorticoids for acute drug-induced liver injury with hyperbilirubinemia: protocol of a multicenter randomized controlled trial. Ther Adv Gastroenterol. 2026 Apr 26;19:17562848261440777. doi: 10.1177/17562848261440777. eCollection 2026.
PubMed 42080196
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Glucocorticoids for Acute Drug Induced Liver Injury With Hyperbilirubinemia: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06922669
- Acronym / sponsor ID
- XHNKKY-ASDILI-RCT
- Conditions
- Drug Induced Liver Injury
- Keywords
- Drug induced liver injury, liver failure, glucocorticoids, clinical trial, Hyperbilirubinemia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 232 participants (estimated)
- Lead sponsor
- General Hospital of Shenyang Military RegionUniversity, hospital or other
- Study start
- 24 Jun 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 10 Apr 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.
Drug-induced liver injury (DILI) can lead to potentially fatal complications, such as acute liver failure and even death. In clinical practice, glucocorticoids have been considered in some cases of DILI, especially patients with hyperbilirubinemia. However, the available evidence remains controversial and its quality is also very limited. Herein, a multicenter randomized controlled trial (RCT) has been designed to explore the efficacy and safety of glucocorticoids in patients with acute DILI and hyperbilirubinemia.
Detailed description
Overall, 232 patients with acute DILI with hyperbilirubinemia will be enrolled. They will be randomly assigned at a ratio of 1:1 to the conventional treatment alone or combined with glucocorticoids groups. The primary endpoint is the improvement of DILI after treatment on second week. Secondary endpoints include the improvement of DILI on fourth week, rates of progressive liver injury, liver failure, liver transplantation, survival, and adverse events. Exploratory endpoints will assess the beneficial population and changes of inflammatory factors following glucocorticoid treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glucocorticoids group | Experimental | Drug: Methylprednisolone, Drug: Magnesium isoglycyrrhizinate, Drug: Glutathione, Drug: Silymarin, Drug: Polyene Phosphatidylcholine, Drug: Ursodeoxycholic acid capsules, Drug: Ademetionine 1,4-Butanedisulfonate, Procedure: Plaslna exchange, Procedure: Liver transplantationGlucocorticoids step-down therapy combined with conventional treatment. |
| Conventional treatment | Active comparator | Drug: Magnesium isoglycyrrhizinate, Drug: Glutathione, Drug: Silymarin, Drug: Polyene Phosphatidylcholine, Drug: Ursodeoxycholic acid capsules, Drug: Ademetionine 1,4-Butanedisulfonate, Procedure: Plaslna exchange, Procedure: Liver transplantationOnly conventional treatment according to the Chinese practice guidelines regarding the management of DILI. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A definite diagnosis of acute DILI;
- 5×ULN ≤ TBIL level at baseline ≤ 20×ULN;
- Age 18-80 years old;
- Sign the informed consent form.
Key exclusion criteria (18 listed)
- Other causes of liver injury, including viral hepatitis, cytomegalovirus infection, Epstein-Barr virus infection, Herpes virus infection, autoimmune liver disease, alcoholic liver disease, hypoxic/ischemic liver disease, Budd-Chiari syndrome, biliary tract disease, Wilson's disease, hemochromatosis, and α1-antitrypsin deficiency;
- Immune checkpoint inhibitors or gynura segetum induced DILI;
- Absolute contraindications to glucocorticoids, such as systemic mold infections or allergies;
- A history of glucocorticoid therapy within 3 months before enrollment;
- A history of diseases requiring glucocorticoid maintenance therapy, such as rheumatoid arthritis, systemic lupus erythematosus, systemic dermatomyositis, etc;
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 |
|---|---|---|
| MethylprednisoloneAlso: MedrolInitially, an intravenous dose of 1 mg/kg/day of methylprednisolone will be administered for one week, with the possibility of extending treatment to two weeks if necessary. Following this, participants will receive oral methylprednisolone tablets, starting at a dose of 40 mg/day. The oral dosage will be gradually tapered based on the participants' condition over a period of 1 to 3 months. | Drug | Glucocorticoids group |
| Magnesium isoglycyrrhizinateIt is suitable for patients with hepatocellular or mixed DILI. A daily dose of 0.15g to 0.2g | Drug | Conventional treatment, Glucocorticoids group |
| GlutathioneIt is suitable for patients with hepatocellular or mixed DILI. A daily dose of 1.2g to 1.8g | Drug | Conventional treatment, Glucocorticoids group |
| SilymarinAlso: LegalonIt is suitable for patients with hepatocellular or mixed DILI. The dosage is 140 mg, taken 2 to 3 times per day. | Drug | Conventional treatment, Glucocorticoids group |
| Polyene PhosphatidylcholineAlso: EssentialeIt is suitable for patients with hepatocellular or mixed DILI. The dosage is 228mg-456mg, taken 3 times per day. | Drug | Conventional treatment, Glucocorticoids group |
| Ursodeoxycholic acid capsulesAlso: UrsofalkIt is suitable for patients with cholestatic or mixed DILI. A daily dose of 10mg-15mg/kg/day. | Drug | Conventional treatment, Glucocorticoids group |
| Ademetionine 1,4-ButanedisulfonateAlso: TransmetiIt is suitable for patients with cholestatic or mixed DILI. A daily dose of 0.5g to 1g. | Drug | Conventional treatment, Glucocorticoids group |
| Plaslna exchangeAlso: Artificial liver supportIt is suitable for patients whose condition continues to worsen or even develop to liver failure. | Procedure or surgery | Conventional treatment, Glucocorticoids group |
| Liver transplantationIt is suitable for patients whose condition continues to worsen or even develop to liver failure. | Procedure or surgery | Conventional treatment, Glucocorticoids group |
Primary outcome
Improvement of DILI on the second week
Time frame: 2 weeks
TBIL level decreases by 50% as compared to the baseline level.
9 secondary outcomes
Improvement of DILI on the fourth week
Time frame: 4 weeks
Progressive liver injury on the second week
Time frame: 2 weeks
Progressive liver injury on the fourth week
Time frame: 4 weeks
Improvement of liver enzymes on the second week
Time frame: 2 weeks
Improvement of liver enzymes on the fourth week
Time frame: 4 weeks
Liver failure
Time frame: 3 months
Liver transplantation
Time frame: 3 months
Survival
Time frame: 3 months
Adverse events
Time frame: 3 months
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 18 Dec 2025.
- Results publication: PubMed 22806342Hou FQ, Zeng Z, Wang GQ. Hospital admissions for drug-induced liver injury: clinical features, therapy, and outcomes. Cell Biochem Biophys. 2012 Nov;64(2):77-83. doi: 10.1007/s12013-012-9373-y.
- Results publication: PubMed 27426618Hu PF, Wang PQ, Chen H, Hu XF, Xie QP, Shi J, Lin L, Xie WF. Beneficial effect of corticosteroids for patients with severe drug-induced liver injury. J Dig Dis. 2016 Sep;17(9):618-627. doi: 10.1111/1751-2980.12383.
- Results publication: PubMed 39183394Chai L, Wang R, Teschke R, Jin S, Deng J, Qi X. Successful corticosteroid therapy for severe liver injury secondary to herbal traditional Chinese medicine, Mega Defends X, assessed for causality by the updated RUCAM: A case report. Medicine (Baltimore). 2024 Aug 23;103(34):e39439. doi: 10.1097/MD.0000000000039439.
- Results publication: PubMed 38402364Mao Y, Ma S, Liu C, Liu X, Su M, Li D, Li Y, Chen G, Chen J, Chen J, Zhao J, Guo X, Tang J, Zhuge Y, Xie Q, Xie W, Lai R, Cai D, Cai Q, Zhi Y, Li X; Technology Committee on DILI Prevention, Management, Chinese Medical Biotechnology Association; Study Group on Drug-Induced Liver Disease, Chinese Society of Hepatology, Chinese Medical Association. Chinese guideline for the diagnosis and treatment of drug-induced liver injury: an update. Hepatol Int. 2024 Apr;18(2):384-419. doi: 10.1007/s12072-023-10633-7. Epub 2024 Feb 24.
- Derived from this study: PubMed 42080196Li Q, Lin Y, Zeng X, Zhou L, Wang F, Ye Q, Gao Y, Guo L, Zhu J, Li J, Li Y, Shao L, Hu Y, Xiao J, Jia A, Wang D, Chang L, Wang J, Zhang J, Wang R, Gao F, Wu Q, Hu P, Zhu C, Cai L, Ran Y, Li Y, Zhang J, Ran Y, Wang C, Wang N, Zhang J, Zhang X, Li J, Sun J, Chu Y, Ma Y, Wang T, Zheng Z, Shen Y, Qi X, Xie W. Efficacy and safety of glucocorticoids for acute drug-induced liver injury with hyperbilirubinemia: protocol of a multicenter randomized controlled trial. Ther Adv Gastroenterol. 2026 Apr 26;19:17562848261440777. doi: 10.1177/17562848261440777. eCollection 2026.
- 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.
Xingshun Qi principal investigator
Department of Gastroenterology, General Hospital of Northern Theater Command
Weifen Xie principal investigator
Shanghai Changzheng Hospital
Xin Zeng principal investigator
Shanghai East Hospital of Tongji University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methylprednisolone, Magnesium isoglycyrrhizinate and Glutathione in people with Drug Induced Liver Injury, run by General Hospital of Shenyang Military Region at 1 site in China.
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 4 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 18 Dec 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 China. 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. 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?
Contact Xingshun Qi (18909881019, xingshunqi@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of DILI on the second week (time frame: 2 weeks). 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 NCT06922669, which also lists 5 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 18 Dec 2025.