NAFLD
Conditions
Interventions
placebo group:Oral placebo
Kelong capsule group:Oral Kelong capsule
Sponsors
Longhua Hospital Affiliated to Shanghai University of traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Meet the diagnostic criteria of nonalcoholic fatty liver disease; (2) Meet the diagnostic criteria of damp heat accumulation syndrome in traditional Chinese medicine; (3) The age is between 18 and 65 years old; (4) The level of serum alanine aminotransferase (ALT) increased slightly, which was defined as the increase of ALT = 2.5 times the upper limit of normal; (5) Liver cap = 259db / M (moderate fatty liver); (6) Informed consent, voluntary test, and the process of obtaining informed consent shall comply with the provisions of GCP.
Exclusion criteria
Exclusion criteria: (1) Patients with serious primary diseases such as cardiovascular, cerebrovascular, urinary and hematopoietic systems, malignant tumors, other serious complications or psychosis; (2) Patients with type 1 diabetes or uncontrolled type 2 diabetes were defined as glycosylated hemoglobin (HbA1c) = 9.5%, or had adjusted hypoglycemic drugs 2 months before enrollment, or had serious hypoglycemic events in the past; (3) Severe liver function injury is defined as the increase of aspartate aminotransferase (AST) = 5 times the upper normal limit, or the increase of total bilirubin = 1.5 times the upper normal limit; (4) Severe renal insufficiency is defined as blood creatinine (SCR) = 178 µ Mol / L, or glomerular filtration rate (EGFR) 100ng / ml, and imaging showed the possibility of malignant space occupying of liver, or AFP lasted for 3 months > 100ng / ml; (9) Pregnant and lactating women and women who refuse to maintain the contraceptive measures approved by the researcher throughout the study; (10) Those who have participated in other clinical trials in recent 3 months; (11) Those who cannot follow the doctor's advice to perform behavioral intervention; (12) Suspected to have a history of alcohol and drug abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The liver cap level decreased by at least 30% from baseline or returned to the normal range (within 239db / M);Serum ALT level decreased by at least 30% from baseline or returned to the normal range (within 40u / L); | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes of lipid metabolism: triglyceride (TG), total cholesterol (TC), low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C);;Changes of other liver function indexes: aspartate aminotransferase (AST), glutamyltranspeptidase (GGT), alkaline phosphatase (AKP), total bilirubin (TBIL), direct bilirubin (DBIL);Changes in body measurements: body mass index (BMI), waist circumference, hip circumference, waist hip ratio;Changes of TCM syndrome score;Changes of insulin resistance index (HOMA-IR);; | — |
Countries
china
Contacts
Public Contactguang JI
Outcome results
None listed