A Phase IV Study of Huazhi Rougan Granule in the Treatment of Non-alcoholic Simple Fatty Liver

NCT ID: NCT06202456

Last Updated: 2024-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 2007 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-13
• Study Completion Date: 2022-06-09

Brief Summary

An open Label, Single-arm, Multicenter phase IV study; There was a 2-week screening period and a 12-week / 24-week treatment period

Conditions

Efficacy and Safety

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Huazhi Rougan granule

Group Type: EXPERIMENTAL

Huazhi Rougan granule

Intervention Type: DRUG

Huazhi Rougan granule

Interventions

Huazhi Rougan granule

Huazhi Rougan granule

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. ≥18 years old;

2. Those who meet the diagnostic criteria of non-alcoholic simple fatty liver and traditional chinese medicine syndrome classification of damp-heat obstruction syndrome;

3. Voluntarily sign informed consent;

4. Liver-to-spleen CT ratio < 1.0; The imaging findings of liver were consistent with the diagnostic criteria of diffuse fatty liver;

5. HbA1c≤6.5%；ALT、AST、TBil≤2×ULN；GFR≥60（ml/min/1.73m2）.

Exclusion Criteria

1. Fatty liver caused by chronic heart failure, malnutrition and pregnancy, encephalopathy fatty liver syndrome (Reye syndrome), B-lipoprotein deficiency, localized fatty liver; Fatty liver caused by diabetes, long-term use of hormones, enteritis, gastrointestinal postoperative chronic infection, etc.; Small intestinal bypass surgery, hepatocyte toxicity injury, chronic febrile diseases such as tuberculosis, ulcerative nodules;

2. Severe fatty liver with ascites, edema, hyponatremia and other suspected cirrhosis; Hepatitis or cirrhosis caused by viruses, drug poisoning, immune diseases and other factors;

3. Pregnant and lactating women, women of childbearing age who do not take effective contraceptive measures (such as condoms, hormonal contraceptives, intrauterine devices) or male subjects who do not want to use contraception;；

4. Patient with serious primary cardiovascular disease, kidney disease and other serious diseases that affect survival;

5. Patient with a history of cancer;

6. Patient with HCV antibody, HIV antibody positive or HBsAg positive and HBV-DNA titer positive;

7. Have a history of alcohol abuse (alcohol equivalent male≥30g/d, female ≥20g/d) or drug abuse；

8. Allergic to the components of this drug；；

9. Those who participated in other clinical investigators within 3 months prior to screening;

10. Those who with a history of diabetes；

11. Patients who had used the same traditional Chinese medicine for the treatment of non-alcoholic simple fatty liver within 2 weeks before screening (except experimental drugs);

12. The investigators consider she/he inappropriate to participate in this study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shandong New Time Pharmaceutical Co., LTD

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Longhua Hospital Shanghai University of Traditional Chinese Medicine

Shanghai, , China

Countries

China

Other Identifiers

NTP-HZRG-G-IV

Identifier Type: -

Identifier Source: org_study_id