A Phase IV Study of Huazhi Rougan Granule

A Placebo Control, Randomized, Double-blind, 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)

A Placebo control, Randomized, Double-blind, 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 Overview

• Status: Completed
• Conditions: A Phase IV Trial to Investigate the Efficacy and Safety of Huazhi Rougan Granule in the Treatment of Non-alcoholic Simple Fatty Liver
• Intervention / Treatment: Drug: Huazhi Rougan Granule Placebo granule

• Study Type: Interventional
• Enrollment (Actual): 282
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Longhua Hospital Shanghai University of Traditional Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ≥18 and≤65 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;

    • Liver-to-spleen CT ratio ≤ 0.8; The imaging findings of liver were consistent with the diagnostic criteria of diffuse fatty liver; ④ Voluntarily sign informed consent. The legal representative can sign informed consent on behalf of the patient who are unable to sign； ⑤ FPG≤7.0mmol/L 、HbA1c≤6.5%；ALT、AST、TBil≤2×ULN.

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, hypokalemia and other suspected cirrhosis; Hepatitis or cirrhosis caused by viruses, drug poisoning, immune diseases and other factors;；

    • Those who had used any Chinese or Western drugs for the treatment of simple fatty liver within one month before randomization；

      • Pregnant or 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;；

        • Patients with serious primary cardiovascular diseases, liver diseases, kidney diseases, hematological diseases, lung diseases, tumors, AIDS and other serious diseases that affect survival. For example: abnormal kidney function: creatinine higher than the upper limit of normal; Abnormal liver function: γ-GT>200U/L or ALT >2×ULN or AST>2×ULN; A clinically significant arrhythmia；

          ⑥ According to the 2010 guidelines for the prevention and treatment of dyslipidemia, patients with dyslipidemia requiring lipid-lowering drugs intervention：TC≥6.99mmol/L（270mg/dl）or LDL-C≥4.92mmol/L（190mg/dl）；

          ⑦ Persons without or with limited capacity for civil conduct；

          ⑧ Those who has suspected or confirmed history of alcohol abuse (alcohol equivalent male≥40g/d, female ≥20g/d) or drug abuse；

          ⑨ Allergic to the components of this drug；

          ⑩ Those who participated in other clinical investigators within 3 months prior to screening；

          ⑪ The investigators consider she/he inappropriate to participate in this study。

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Huazhi Rougan granule; Take with boiling water ,3 times a day, for 24 weeks;	Drug: Huazhi Rougan Granule Placebo granule; Experimental: Huazhi Rougan granule Placebo Comparator: Placebo granule Placebo Comparator: Placebo granule
Placebo Comparator: Placebo granule; Take with boiling water ,3 times a day, for 24 weeks;	Drug: Huazhi Rougan Granule Placebo granule; Experimental: Huazhi Rougan granule Placebo Comparator: Placebo granule Placebo Comparator: Placebo granule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Liver-to-spleen CT ratio	week 24

Secondary Outcome Measures

Outcome Measure	Time Frame
Laboratory test index:Traditional Chinese medicine (TCM) syndrome points	week 24
TG、ALT、AST、γ-GT、TBIL、HOMA-IR	week 24
AE、SAE	week 24

Collaborators and Investigators

• Sponsor: Shandong New Time Pharmaceutical Co., LTD

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2017
• Primary Completion (Actual): November 8, 2018
• Study Completion (Actual): November 8, 2018

Study Registration Dates

• First Submitted: December 13, 2023
• First Submitted That Met QC Criteria: January 1, 2024
• First Posted (Actual): January 3, 2024

Study Record Updates

• Last Update Posted (Actual): January 3, 2024
• Last Update Submitted That Met QC Criteria: January 1, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver
• Other Study ID Numbers: NTPC-HZRG-V1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No