Metabolic-associated Fatty Liver Disease (MAFLD)Phase 2NCT06798948
Effect of the Combined Application of Cynara Scolymus, Silybum Marianum, Curcuma Longa, and Glycyrrhiza Glabra in Improving Metabolic Associated Fatty Liver Disease : a Randomized Clinical Trial
A Phase 2 study testing Combination of cynara scolymus, silybum marianum, curcuma longa, and glycyrrhiza glabra in people with Metabolic-associated Fatty Liver Disease (MAFLD), run by Li Lab,MD at 2 sites in China.
Trial summary
Metabolic-associated fatty liver disease (MAFLD) is a chronic progressive liver disease caused by nutrient excess and insulin resistance (IR) in genetically susceptible individuals. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Metabolic-associated Fatty Liver Disease (MAFLD)
- What is being tested?
- Combination of cynara scolymus, silybum marianum, curcuma longa, and glycyrrhiza glabra
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesChina
- Study dates
- 1 Mar 2025to 31 Dec 2027
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who meet the clinical diagnostic criteria for metabolic-associated fatty liver disease and have mild to moderate fatty liver.
- Aged 18-65, regardless of gender.
- Have not taken any liver-protecting medications in the past 3 months.
- Informed subjects who voluntarily sign the informed consent form and agree to participate in all visits and treatments as required by the trial protocol.
Who cannot join
- Excessive alcohol consumption or inability to quantify alcohol consumption within the past 12 months (weekly ethanol intake: ≥210g for males, ≥140g for females).
- Currently pregnant and/or lactating women, or women planning to become pregnant within the next 3 months.
- Diagnosed with allergies or other known or suspected allergic reactions (systemic, inhaled, or localized), with a history of sensitivity to ingredients in the product formula.
- Previous or current use of liver-protecting products containing ingredients such as cynara scolymus, silybum marianum, curcuma longa, and glycyrrhiza glabra , etc.
- Coexisting with other hepatobiliary diseases, such as autoimmune liver disease, viral hepatitis, liver fibrosis, cirrhosis, drug-induced liver disease, Wilson's disease, etc.
- Diagnosed with obesity, hypertension, and/or diabetes and taking relevant therapeutic drugs (e.g., orlistat for obesity treatment, statins for lipid-lowering, hydrochlorothiazide, metoprolol, bisoprolol for hypertension treatment, metformin, dapagliflozin for diabetes treatment, etc.).
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- Coexisting with specific diseases that can lead to fatty liver, such as total parenteral nutrition, abetalipoproteinemia, congenital lipoatrophic diabetes, celiac disease, etc.
- Long-term use of drugs known to cause hepatic steatosis or steatohepatitis (e.g., amiodarone, methotrexate, tamoxifen, glucocorticoids, etc.).
- Coexisting with severe cardiovascular and cerebrovascular diseases or renal insufficiency.
- Unstable weight and metabolic parameters within 6 to 8 weeks before randomization, with weight changes exceeding 5% or rapid weight loss (>1.6 kg/week).
- History of malignancy within the past five years (except for localized skin basal cell carcinoma), regardless of recurrence or metastasis.
- History of immunosuppression or immunodeficiency disorders (including HIV or AIDS), or current use of immunosuppressive drugs or radiotherapy.
- Chronic diseases and endocrine disorders such as asthma, epilepsy, hyperthyroidism or hypothyroidism, and/or the use of corresponding therapeutic drugs.
- History of drug abuse.
- History of antibiotic use within the past month.
- Participation in other population intervention studies within the past 3 months or receipt of other non-study group treatments during the study.
- Other conditions or diseases that, in the judgment of other researchers, may reduce the likelihood of enrollment or complicate the enrollment process, such as frequent changes in work environment, unstable living environment, etc., which may lead to loss to follow-up; inconvenience in daily living, etc.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
The Second Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Select..., 310053
tao Sun, +8618258296259, hqingling0306@163.com
08615705811859, zcmunutrition@163.com
- Recruiting
Zhejiang Xinhua Hospital
Hangzhou, Zhejiang, 310005
qingling huang, 08615267148306, hqingling0306@163.com
kaixin pan, 08618966486859, pankaixin@zcmu.edu.cn
About this study
Metabolic-associated fatty liver disease (MAFLD) is a chronic progressive liver disease caused by nutrient excess and insulin resistance (IR) in genetically susceptible individuals. With the prevalence of obesity and type 2 diabetes, the morbidity and incidence of MAFLD have been increasing globally, particularly in China. MAFLD and metabolic syndrome as well as type 2 diabetes are mutually causal, jointly promoting the incidence of atherosclerotic cardiovascular disease, chronic kidney disease, liver decompensation, and malignant tumors such as hepatocellular carcinoma. MAFLD has become an increasingly severe public health issue in China. Effective clinical interventions for MAFLD patients are of great public health significance for the prevention of terminal diseases.
Cynara scolymus, silybum marianum, curcuma longa, and glycyrrhiza glabra are traditional Chinese medicinal herbs that have demonstrated significant effectiveness in improving metabolic diseases. Cynara scolymus contains polyphenols, flavonoids, terpenes, and other substances, possessing antioxidant, anti-aging, anti-tumor, anti-microbial, antihypertensive, and kidney-tonifying properties. Silybum marianum belongs to the Compositae family and has the effects of clearing heat and detoxifying, soothing the liver, and promoting bile flow. The active ingredient of silybum marianum is silymarin, a flavonoid compound, which has antioxidant and anti-hepatic fibrotic effects, protecting hepatocytes from damage by free radicals and promoting hepatocyte regeneration and repair. Curcuma longa is a flowering plant of the zingiberaceae family, and its active ingredient curcumin has multiple functional properties such as anti-tumor, anti-inflammatory, hypoglycemic, and antioxidant activities. Glycyrrhiza glabra is one of the commonly used medicinal plants, possessing the effects of clearing heat and detoxifying, tonifying the spleen and benefiting qi, nourishing the lungs, and resolving phlegm. Its main active ingredients include triterpenoid saponins, flavonoids, and polysaccharides, which exhibit various pharmacological effects such as antioxidant, immunoregulatory, antiviral, and anti-tumor activities. At the human population level, there is currently no research on the combined intervention of cynara scolymus, silybum marianum, curcuma longa, and glycyrrhiza glabra in patients with MAFLD.
Therefore, this study intends to conduct a randomized controlled double-blind trial to explore the effects of the combined application of cynara scolymus, silybum marianum, curcuma longa, and glycyrrhiza glabra on liver function, liver fat content, glucose and lipid metabolism, and other aspects in patients with MAFLD, in order to clarify the health improvement effects of this combined intervention in patients with MAFLD and provide population-based evidence and strategies for health promotion in this patient group.
- Being tested
- Combination of cynara scolymus, silybum marianum, curcuma longa, and glycyrrhiza glabra, Placebo maltodextrin
- Keywords
- Metabolic-associated fatty liver disease (MAFLD), MRI-PDFF, Chinese Medcine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination of cynara scolymus, silybum marianum, curcuma longa, and glycyrrhiza glabraDietary supplement
Oral combination of cynara scolymus, silybum marianum, curcuma longa, and glycyrrhiza glabra
Placebo maltodextrinOther
The patient takes two tablets of the placebo maltodextrin every day
| Study group | Role | What they receive |
|---|---|---|
| Combination of cynara scolymus, silybum marianum, curcuma longa, and glycyrrhiza glabra | Experimental | The patient takes two tablets of the mixture cynara scolymus, silybum marianum, curcuma longa, and glycyrrhiza glabra every day. Receives: Dietary Supplement: Combination of cynara scolymus, silybum marianum, curcuma longa, and glycyrrhiza glabra |
| maltodextrin group | Placebo comparator | The patient takes two tablets of the placebo maltodextrin every day Receives: Other: Placebo maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnetic Resonance Imaging proton density fat fraction in hepatic steatosis
Magnetic Resonance Imaging (MRI) technology utilizes magnetic fields and radiofrequency pulses to conduct non-invasive examinations of tissues. When measuring liver fat content, MRI employs water-fat separation techniques to quantify the proton density of water molecules and fat molecules (PDFF) within the liver, thereby providing a quantitative analysis of fat content.
Measured: Baseline, up to 12 weeks of the study
Secondary outcomes (4)
Liver function
Alanine aminotransferase (ALT), aspartate aminotransferase (AST), γ-glutamyltransferase (γ-GT), alkaline phosphatase (ALP), total bilirubin (TBIL), direct bilirubin (DBIL), indirect bilirubin (IBIL), alcohol dehydrogenase (ADH), aldehyde dehydrogenase (ALDH)
Measured: Baseline, up to 6 weeks， up to 12 weeks，up to 16 weeks of the study
Glucose metabolism
Hemoglobin A1c (HbA1c)
Measured: Baseline, up to 6 weeks， up to 12 weeks，up to 16 weeks of the study
Glucose metabolism
Fasting blood glucose
Measured: Baseline, up to 6 weeks， up to 12 weeks，up to 16 weeks of the study
Lipid metabolism
Serum triglycerides (TG), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), apolipoprotein A-I (ApoA-I), apolipoprotein B (Apo B).
Measured: Baseline, up to 6 weeks， up to 12 weeks，up to 16 weeks of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start1 Mar 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Metabolic-associated Fatty Liver Disease (MAFLD)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention Group: combination of cynara scolymus, silybum marianum, curcuma longa, and glycyrrhiza glabra Control Group: placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Li Lab,MD
- Sponsor type
- Other government
- Collaborators
- Xin Hua Hospital of Zhejiang Province
- Responsible party
- Sponsor-investigator, Li Lab,MD, Zhejiang Chinese Medical University
- Investigators
- Songtao Li, Study chair, Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06798948
- Sponsor's protocol ID
- Evaluation of CSCG on MAFLD
- Status last verified
- Apr 2025
- First submitted
- 14 Jan 2025
- Last updated
- 23 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Protect volunteers' personal health data and personal privacy
Publications
Li BY, Xi Y, Liu YP, Wang D, Wang C, Chen CG, Fang XH, Li ZX, Chen YM. Effects of Silybum marianum, Pueraria lobate, combined with Salvia miltiorrhiza tablets on non-alcoholic fatty liver disease in adults: A triple-blind, randomized, placebo-controlled clinical trial. Clin Nutr ESPEN. 2024 Oct;63:2-12. doi: 10.1016/j.clnesp.2024.06.003. Epub 2024 Jun 10.
PubMed 38879879Wang X, Jin Y, Di C, Zeng Y, Zhou Y, Chen Y, Pan Z, Li Z, Ling W. Supplementation of Silymarin Alone or in Combination with Salvianolic Acids B and Puerarin Regulates Gut Microbiota and Its Metabolism to Improve High-Fat Diet-Induced NAFLD in Mice. Nutrients. 2024 Apr 14;16(8):1169. doi: 10.3390/nu16081169.
PubMed 38674860Hansen CD, Gram-Kampmann EM, Hansen JK, Hugger MB, Madsen BS, Jensen JM, Olesen S, Torp N, Rasmussen DN, Kjaergaard M, Johansen S, Lindvig KP, Andersen P, Thorhauge KH, Brond JC, Hermann P, Beck-Nielsen H, Detlefsen S, Hansen T, Hojlund K, Thiele MS, Israelsen M, Krag A. Effect of Calorie-Unrestricted Low-Carbohydrate, High-Fat Diet Versus High-Carbohydrate, Low-Fat Diet on Type 2 Diabetes and Nonalcoholic Fatty Liver Disease : A Randomized Controlled Trial. Ann Intern Med. 2023 Jan;176(1):10-21. doi: 10.7326/M22-1787. Epub 2022 Dec 13.
PubMed 36508737Dellinger RW, Holmes HE, Hu-Seliger T, Butt RW, Harrison SA, Mozaffarian D, Chen O, Guarente L. Nicotinamide riboside and pterostilbene reduces markers of hepatic inflammation in NAFLD: A double-blind, placebo-controlled clinical trial. Hepatology. 2023 Sep 1;78(3):863-877. doi: 10.1002/hep.32778. Epub 2022 Nov 22.
PubMed 36082508
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Combined Application of Cynara Scolymus, Silybum Marianum, Curcuma Longa, and Glycyrrhiza Glabra in Improving Metabolic Associated Fatty Liver Disease : a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06798948
- Acronym / sponsor ID
- Evaluation of CSCG on MAFLD
- Keywords
- Metabolic-associated fatty liver disease (MAFLD), MRI-PDFF, Chinese Medcine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Li Lab,MDOther government
- Collaborators
- Xin Hua Hospital of Zhejiang Province
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 29 Jan 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.
Metabolic-associated fatty liver disease (MAFLD) is a chronic progressive liver disease caused by nutrient excess and insulin resistance (IR) in genetically susceptible individuals. With the prevalence of obesity and type 2 diabetes, the morbidity and incidence of MAFLD have been increasing globally, particularly in China. MAFLD and metabolic syndrome as well as type 2 diabetes are mutually causal, jointly promoting the incidence of atherosclerotic cardiovascular disease, chronic kidney disease, liver decompensation, and malignant tumors such as hepatocellular carcinoma. MAFLD has become an increasingly severe public health issue in China. Effective clinical interventions for MAFLD patients are of great public health significance for the prevention of terminal diseases.
Cynara scolymus, silybum marianum, curcuma longa, and glycyrrhiza glabra are traditional Chinese medicinal herbs that have demonstrated significant effectiveness in improving metabolic diseases. Cynara scolymus contains polyphenols, flavonoids, terpenes, and other substances, possessing antioxidant, anti-aging, anti-tumor, anti-microbial, antihypertensive, and kidney-tonifying properties. Silybum marianum belongs to the Compositae family and has the effects of clearing heat and detoxifying, soothing the liver, and promoting bile flow. The active ingredient of silybum marianum is silymarin, a flavonoid compound, which has antioxidant and anti-hepatic fibrotic effects, protecting hepatocytes from damage by free radicals and promoting hepatocyte regeneration and repair. Curcuma longa is a flowering plant of the zingiberaceae family, and its active ingredient curcumin has multiple functional properties such as anti-tumor, anti-inflammatory, hypoglycemic, and antioxidant activities. Glycyrrhiza glabra is one of the commonly used medicinal plants, possessing the effects of clearing heat and detoxifying, tonifying the spleen and benefiting qi, nourishing the lungs, and resolving phlegm. Its main active ingredients include triterpenoid saponins, flavonoids, and polysaccharides, which exhibit various pharmacological effects such as antioxidant, immunoregulatory, antiviral, and anti-tumor activities. At the human population level, there is currently no research on the combined intervention of cynara scolymus, silybum marianum, curcuma longa, and glycyrrhiza glabra in patients with MAFLD.
Therefore, this study intends to conduct a randomized controlled double-blind trial to explore the effects of the combined application of cynara scolymus, silybum marianum, curcuma longa, and glycyrrhiza glabra on liver function, liver fat content, glucose and lipid metabolism, and other aspects in patients with MAFLD, in order to clarify the health improvement effects of this combined intervention in patients with MAFLD and provide population-based evidence and strategies for health promotion in this patient group.
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
- Intervention Group: combination of cynara scolymus, silybum marianum, curcuma longa, and glycyrrhiza glabra Control Group: placebo
| Arm | Type | Receives |
|---|---|---|
| Combination of cynara scolymus, silybum marianum, curcuma longa, and glycyrrhiza glabra | Experimental | Dietary Supplement: Combination of cynara scolymus, silybum marianum, curcuma longa, and glycyrrhiza glabraThe patient takes two tablets of the mixture cynara scolymus, silybum marianum, curcuma longa, and glycyrrhiza glabra every day. |
| maltodextrin group | Placebo comparator | Other: Placebo maltodextrinThe patient takes two tablets of the placebo maltodextrin every day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects who meet the clinical diagnostic criteria for metabolic-associated fatty liver disease and have mild to moderate fatty liver.
- Aged 18-65, regardless of gender.
- Have not taken any liver-protecting medications in the past 3 months.
- Informed subjects who voluntarily sign the informed consent form and agree to participate in all visits and treatments as required by the trial protocol.
Key exclusion criteria (17 listed)
- Excessive alcohol consumption or inability to quantify alcohol consumption within the past 12 months (weekly ethanol intake: ≥210g for males, ≥140g for females).
- Currently pregnant and/or lactating women, or women planning to become pregnant within the next 3 months.
- Diagnosed with allergies or other known or suspected allergic reactions (systemic, inhaled, or localized), with a history of sensitivity to ingredients in the product formula.
- Previous or current use of liver-protecting products containing ingredients such as cynara scolymus, silybum marianum, curcuma longa, and glycyrrhiza glabra , etc.
- Coexisting with other hepatobiliary diseases, such as autoimmune liver disease, viral hepatitis, liver fibrosis, cirrhosis, drug-induced liver disease, Wilson's disease, 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 |
|---|---|---|
| Combination of cynara scolymus, silybum marianum, curcuma longa, and glycyrrhiza glabraOral combination of cynara scolymus, silybum marianum, curcuma longa, and glycyrrhiza glabra | Dietary supplement | Combination of cynara scolymus, silybum marianum, curcuma longa, and glycyrrhiza glabra |
| Placebo maltodextrinThe patient takes two tablets of the placebo maltodextrin every day | Other | maltodextrin group |
Primary outcome
Magnetic Resonance Imaging proton density fat fraction in hepatic steatosis
Time frame: Baseline, up to 12 weeks of the study
Magnetic Resonance Imaging (MRI) technology utilizes magnetic fields and radiofrequency pulses to conduct non-invasive examinations of tissues. When measuring liver fat content, MRI employs water-fat separation techniques to quantify the proton density of water molecules and fat molecules (PDFF) within the liver, thereby providing a quantitative analysis of fat content.
4 secondary outcomes
Liver function
Time frame: Baseline, up to 6 weeks， up to 12 weeks，up to 16 weeks of the study
Glucose metabolism
Time frame: Baseline, up to 6 weeks， up to 12 weeks，up to 16 weeks of the study
Glucose metabolism
Time frame: Baseline, up to 6 weeks， up to 12 weeks，up to 16 weeks of the study
Lipid metabolism
Time frame: Baseline, up to 6 weeks， up to 12 weeks，up to 16 weeks of the study
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 23 Apr 2025.
- Results publication: PubMed 38879879Li BY, Xi Y, Liu YP, Wang D, Wang C, Chen CG, Fang XH, Li ZX, Chen YM. Effects of Silybum marianum, Pueraria lobate, combined with Salvia miltiorrhiza tablets on non-alcoholic fatty liver disease in adults: A triple-blind, randomized, placebo-controlled clinical trial. Clin Nutr ESPEN. 2024 Oct;63:2-12. doi: 10.1016/j.clnesp.2024.06.003. Epub 2024 Jun 10.
- Results publication: PubMed 38674860Wang X, Jin Y, Di C, Zeng Y, Zhou Y, Chen Y, Pan Z, Li Z, Ling W. Supplementation of Silymarin Alone or in Combination with Salvianolic Acids B and Puerarin Regulates Gut Microbiota and Its Metabolism to Improve High-Fat Diet-Induced NAFLD in Mice. Nutrients. 2024 Apr 14;16(8):1169. doi: 10.3390/nu16081169.
- Results publication: PubMed 36508737Hansen CD, Gram-Kampmann EM, Hansen JK, Hugger MB, Madsen BS, Jensen JM, Olesen S, Torp N, Rasmussen DN, Kjaergaard M, Johansen S, Lindvig KP, Andersen P, Thorhauge KH, Brond JC, Hermann P, Beck-Nielsen H, Detlefsen S, Hansen T, Hojlund K, Thiele MS, Israelsen M, Krag A. Effect of Calorie-Unrestricted Low-Carbohydrate, High-Fat Diet Versus High-Carbohydrate, Low-Fat Diet on Type 2 Diabetes and Nonalcoholic Fatty Liver Disease : A Randomized Controlled Trial. Ann Intern Med. 2023 Jan;176(1):10-21. doi: 10.7326/M22-1787. Epub 2022 Dec 13.
- Results publication: PubMed 36082508Dellinger RW, Holmes HE, Hu-Seliger T, Butt RW, Harrison SA, Mozaffarian D, Chen O, Guarente L. Nicotinamide riboside and pterostilbene reduces markers of hepatic inflammation in NAFLD: A double-blind, placebo-controlled clinical trial. Hepatology. 2023 Sep 1;78(3):863-877. doi: 10.1002/hep.32778. Epub 2022 Nov 22.
- Individual participant dataSharing planned: No. Protect volunteers' personal health data and personal privacy
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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.
Songtao Li study chair
Zhejiang Chinese Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Combination of cynara scolymus, silybum marianum, curcuma longa, and glycyrrhiza glabra in people with Metabolic-associated Fatty Liver Disease (MAFLD), run by Li Lab,MD at 2 sites 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 17 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 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Qingling Huang (08615267148306, hqingling0306@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Magnetic Resonance Imaging proton density fat fraction in hepatic steatosis (time frame: Baseline, up to 12 weeks of the study). 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 NCT06798948, which also lists 4 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 23 Apr 2025.