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

NCT06202456 | Completed Phase 4

• 1 other identifier: NTP-HZRG-G-IV
• Study Type: interventional
• Target: 2,007
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 (3)

• The reduction of traditional Chinese medicine (TCM) syndrome integral

  12 weeks

• the reduction of ALT

  12 weeks

• the reduction of blood lipid index

  12 weeks

Study Arms (1)

Huazhi Rougan granule

EXPERIMENTAL

Drug: Huazhi Rougan granule

Interventions

Huazhi Rougan granule DRUG

Huazhi Rougan granule

Huazhi Rougan granule

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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）.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shandong New Time Pharmaceutical Co., LTD: lead

Study Sites (1)

Longhua Hospital Shanghai University of Traditional Chinese Medicine

Shanghai, China

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: January 11, 2024
• Study Start: May 13, 2020
• Primary Completion: June 9, 2022
• Study Completion: June 9, 2022
• Last Updated: January 11, 2024

Record last verified: 2024-01

Locations

CN (1)