A high evidence-based RCT study of Huatan Qushi Huoxue granule on intervention of obese non-alcoholic steatosis patients

Not Applicable

Recruiting

• Conditions: non-alcoholic steatohepatitis

• Registration Number: ITMCTR2200006122
• Lead Sponsor: The First Affiliated Hospital of Henan University of CM

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

(1) Age: 18 to 65 years old, regardless of gender.
(2) Meeting both Chinese and Western medical diagnostic criteria.
(3) 1 times the upper limit of normal < serum ALT decreased = 3 times the upper limit of normal for more than 4 weeks.
(4) Fasting blood glucose = 7.0 mmol/L.
(5) Signed informed consent.
(6) Not taking other drugs for the treatment of NAFLD or who have discontinued other drugs for the treatment of NASH before 4 weeks of inclusion for observation.

Exclusion Criteria

(1) viral hepatitis, drug-related liver disease, total parenteral nutrition, hepatomegaly, autoimmune liver disease, etc.
(2) Those suffering from serious heart, brain, kidney, hematopoietic system diseases and emotional diseases such as anxiety, depression and psychiatric disorders.
(3) Fatty liver caused by long-term use of glucocorticoids, chlorpromazine, insulin, etc.
(4) Patients with type I diabetes mellitus.
(5) Patients with various types of malignant tumors or those with previous history of malignant tumors
(6) Pregnant and lactating women.
(7) Those who are participating in other clinical trials.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
BMI;CAP value of controlled attenuation parameter of transient elastic imaging of liver;ALT\AST;

Secondary Outcome Measures

Name	Time	Method
FINS;HOMA-IR;FFA;BFR;TG\TC\HDL-C\LDL-C;WHR;FPG;