A Phase IV Study of Huazhi Rougan Granule

NCT ID: NCT06188611

Last Updated: 2024-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 282 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-18
• Study Completion Date: 2018-11-08

Brief Summary

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)

Conditions

A Phase IV Trial to Investigate the Efficacy and Safety of Huazhi Rougan Granule in the Treatment of Non-alcoholic Simple Fatty Liver

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Huazhi Rougan granule

Take with boiling water ,3 times a day, for 24 weeks;

Group Type: EXPERIMENTAL

Huazhi Rougan Granule Placebo granule

Intervention Type: DRUG

Experimental: Huazhi Rougan granule Placebo Comparator: Placebo granule Placebo Comparator: Placebo granule

Placebo granule

Take with boiling water ,3 times a day, for 24 weeks;

Group Type: PLACEBO_COMPARATOR

Huazhi Rougan Granule Placebo granule

Intervention Type: DRUG

Experimental: Huazhi Rougan granule Placebo Comparator: Placebo granule Placebo Comparator: Placebo granule

Interventions

Huazhi Rougan Granule Placebo granule

Experimental: Huazhi Rougan granule Placebo Comparator: Placebo granule Placebo Comparator: Placebo granule

Intervention Type: DRUG

Eligibility Criteria

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。

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shandong New Time Pharmaceutical Co., LTD

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Longhua Hospital Shanghai University of Traditional Chinese Medicine

Shanghai, , China

Countries

China

Other Identifiers

NTPC-HZRG-V1

Identifier Type: -

Identifier Source: org_study_id