A Phase IV Study of Huazhi Rougan Granule in the Treatmen... | NCT06202456

NCT06202456

Protocol Section

Identification Module

Results Section

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No data is available for this block.

Annotation Section

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Document Section

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Derived Section

Miscellaneous Info Module

Status Module

Design Module

Interventional Study Design

Biospecimen

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No data is available for this block.

Label	Type	Description	Intervention Names
Huazhi Rougan granule	Experimental		Drug: Huazhi Rougan granule

Name	Type	Description	Arm Group Labels	Other Names
Huazhi Rougan granule	Drug	Huazhi Rougan granule	Huazhi Rougan granule

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Liver-to-spleen CT ratio	Clinical recovery: liver/spleen CT ratio ≥ 1; Obvious effect: liver/spleen CT ratio decreased by 2 grades (severe → mild); Effective: Liver/spleen CT ratio decreased by 1 grade (severe → moderate, or moderate → mild) :+ Ineffective: liver/spleen CT ratio did not change or even increased.	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
The reduction of traditional Chinese medicine (TCM) syndrome integral	Clinical recovery: syndrome integral decreased ≥ 95%; Obvious Effective:70%≤the reduction of syndrome integral <95%; Effective :30%≤the reduction of syndrome score <70%; Ineffective: less than 30% reduction in syndrome integral. note: The reduction of TCM syndrome integral (%) = (Pre-treatment integral - post-treatment integral)/Pre-treatment integralx 100%

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

≥18 years old;
Those who meet the diagnostic criteria of non-alcoholic simple fatty liver and traditional chinese medicine syndrome classification of damp-heat obstruction syndrome;
Voluntarily sign informed consent;
Liver-to-spleen CT ratio < 1.0; The imaging findings of liver were consistent with the diagnostic criteria of diffuse fatty liver;
HbA1c≤6.5%；ALT、AST、TBil≤2×ULN；GFR≥60（ml/min/1.73m2）.

Exclusion Criteria:

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;
Severe fatty liver with ascites, edema, hyponatremia and other suspected cirrhosis; Hepatitis or cirrhosis caused by viruses, drug poisoning, immune diseases and other factors;
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;；
Patient with serious primary cardiovascular disease, kidney disease and other serious diseases that affect survival;
Patient with a history of cancer;
Patient with HCV antibody, HIV antibody positive or HBsAg positive and HBV-DNA titer positive;
Have a history of alcohol abuse (alcohol equivalent male≥30g/d, female ≥20g/d) or drug abuse；
Allergic to the components of this drug；；
Those who participated in other clinical investigators within 3 months prior to screening;
Those who with a history of diabetes；
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);
The investigators consider she/he inappropriate to participate in this study.