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

Phase 4

Completed

• Conditions: Efficacy and Safety
• Interventions: Drug: Huazhi Rougan granule

• Registration Number: NCT06202456
• Lead Sponsor: Shandong New Time Pharmaceutical Co., LTD

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-13
• Primary Completion: 2022-06-09
• Study Completion: 2022-06-09
• Study First Submitted: 2023-12-13
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-01
• Last Update Submitted: 2024-01-01
• Study First Posted: 2024-01-11
• Last Update Posted: 2024-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2007

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Huazhi Rougan granule	Huazhi Rougan granule	-

Primary Outcome Measures

Name	Time	Method
Liver-to-spleen CT ratio	12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
The reduction of traditional Chinese medicine (TCM) syndrome integral	12 weeks	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%
the reduction of ALT	12 weeks	Clinical control: Liver enzymology (ALT) returned to normal; + Obvious effect: liver enzyme (ALT) index decreased by ≥50%; Effective: Liver enzyme (ALT) index decreased \<50% but≥ 30%; Ineffective: Liver enzyme (ALT) index decreased \<30%。
the reduction of blood lipid index	12 weeks	blood lipid index including TC、TG、and HDL-C

Trial Locations

Locations (1)

Longhua Hospital Shanghai University of Traditional Chinese Medicine; 🇨🇳 Shanghai, China