Clinical trial NCT06202456: A Phase IV Study of Huazhi Rougan Granule in the Treatment of Non-alcoholic Simple Fatty Liver
Official title: A Single-arm, Multicenter Phase IV Study to Investigate the Efficacy and Safety of Huazhi Rougan Granule in the Treatment of Non-alcoholic Simple Fatty Liver (Damp-heat Obstruction Syndrome: Shi-Re-Zhong-Zu Zheng)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Efficacy and Safety
Lead sponsor: Shandong New Time Pharmaceutical Co., LTD
Sponsor class: INDUSTRY
First posted: 2024-01-11
Enrollment: 2007
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Liver-to-spleen CT ratio
timeFrame: 12 weeks
Secondary outcomes:
measure: The reduction of traditional Chinese medicine (TCM) syndrome integral
timeFrame: 12 weeks
measure: the reduction of ALT
timeFrame: 12 weeks
measure: the reduction of blood lipid index
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Longhua Hospital Shanghai University of Traditional Chinese Medicine
Study officials:
References: