non-alcoholic steatohepatitis
Conditions
Interventions
treatment group:Basic treatment + Kuhuang granules orally × 12 weeks
Control group:Basic treatment + Kuhuang granule mimetic agent was orally × for 12 weeks
Sponsors
Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.18 years old= age = 70 years old gender is not limited 2.Meet the above criteria for the diagnosis of diseases in Western medicine and Chinese medicine and meet the following conditions: 1)1 ULN= ALT=3 ULN and/or 1 ULN=AST=3 ULN and/or GGT>1.5 ULN; 2)TBIL <1.5ULN (except for patients with Gilbert's syndrome); 3)Liver transient elastography (Fibroscan) CAP = 238 dB/m and liver transient elastography (Fibroscan) LSM <15.0kPa; or histologically confirmed diagnosis of nonalcoholic steatohepatitis (NASH) within 6 months prior to study entry with exception to cirrhosis. 4)It meets the syndrome differentiation standards of traditional Chinese medicine damp heat accumulation syndrome. 3.Weight loss of <5% within 1 month prior to screening; 4.Subjects voluntarily join the study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Combined with other conditions that cause hepatic steatosis; 2.Combined with other severe liver disease; 3.Concomitant with other systemic serious diseases; 4.Those who are allergic to the known components of the test drug or have an allergic constitution; 5.Patients with poorly medically controlled hypertension and poorly medically controlled type II. diabetes mellitus; 6.Women who are breastfeeding or pregnant or trying to conceive; 7.Use of drugs within 2 weeks prior to the first use of study drug that may affect outcome assessment; 8.Those who have participated in other interventional clinical trials within 4 weeks prior to study entry; 9.Other conditions that in the opinion of the investigator are not suitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ALT AST GGT; | — |
Secondary
| Measure | Time frame |
|---|---|
| TCTGHDL-CLDL-C;NFS;Patient Quality of Life Survey (SF-36);Weight BMI waist-to-hip ratio;TCM syndrome evaluation;Liver fat content (CAP);Liver fibrosis changes (LSM );Degree of hepatic steatopathy (ultrasound); | — |
Countries
China
Contacts
Public ContactLi Li
Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
Outcome results
None listed