MASLD
Conditions
Interventions
Control group:Polyenylphosphatidylcholine capsules
Experimental group: Jigucao Capsule
Sponsors
Dongzhimen Hospital, Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Patients with moderate to severe MASLD (CAP control attenuation index > 259) who have no history of excessive alcohol consumption (men consuming <30g of ethanol/day women <20g/day) and no other specific causes that can lead to fatty liver with imaging or histological evidence of diffuse hepatocyte steatosis and without other liver diseases such as autoimmune hepatitis drug-induced hepatitis Wilson's disease hepatic fibrosis or cirrhosis. (1) ALT within normal range or up to 2 times the upper limit of normal (ULN). (2) Age between 18 and 65 years gender unrestricted. (3) Voluntarily participating in this trial and able to comply with the study's treatment plan and follow-up requirements. (4) Able to understand and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Combine with other severe chronic diseases such as cardiovascular disease kidney disease diabetes malignant tumors etc. (2) Patients allergic to the ingredients of Jigucao Capsule or with a history of other drug allergies. (3) Women who are breastfeeding or pregnant. (4) Received liver disease-related medication within the recent period (within 3 months before the start of the study) such as lipid-lowering drugs antiviral drugs etc. (5) Recent use of drugs that may affect the liver: such as antitumor drugs antitubercular drugs antifungal drugs etc. and the time since discontinuation has not exceeded the specified period. (6) Patients who cannot follow up on time or cannot complete the entire treatment cycle. (7) Patients with a history of alcohol or drug abuse which may affect liver function. (8) Patients who are currently participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| liver lipid contents(CAP); | — |
Secondary
| Measure | Time frame |
|---|---|
| HbA1c;ALT;AST ;GGT;TBIL;ALP;TC ;TG;HDL-C;LDL-C;C-Peptide;Insulin;Oral glucose tolerance test;clinical symptoms; | — |
Countries
China
Contacts
Public ContactLi xiaoke
Dongzhimen Hospital, Beijing University of Chinese Medicine
Outcome results
None listed