Therapeutic Effects of Compound Zhenzhu Tiaozhi Capsules in NAFLD

Therapeutic Effects of Compound Zhenzhu Tiaozhi Capsules in Nonalcoholic Fatty Liver disease-a Randomized Controlled Study

This is a randomised clinical trial which aims to evaluate the efficacy of Compound Zhenzhu Tiaozhi capsules in the treatment of NAFLD and analyze the relationship between improvement in NAFLD parameters and changes in intestinal functions.

Study Overview

• Status: Unknown
• Conditions: Nonalcoholic Fatty Liver Disease
• Intervention / Treatment: Dietary supplement: TLC; Drug: metformin; Drug: Compound Zhenzhu Tiaozhi capsule; Drug: Simvastatin

Detailed Description

This is a randomised clinical trial which aims to evaluate the efficacy of Compound Zhenzhu Tiaozhi capsules in the treatment of NAFLD and analyze the relationship between improvement in NAFLD parameters and changes in intestinal functions. In this study, the investigators will (1)evaluate the relationship between the function of intestinal mucosal barrier, SIBO, and NAFLD;(2)assess the effects of Compound Zhenzhu Tiaozhi capsules on intrahepatic fat content, hepatic noninvasive score, liver biochemical parameters, blood lipid, and insulin resistance. To evaluate the therapeutic effects of Compound Zhenzhu Tiaozhi capsules on the treatment of NAFLD, and determine whether the risk stratification of atherosclerotic cardiovascular disease (ASCVD) and quality of life (using the 36-Item Short Form Health Survey [SF-36]) can be improved in NAFLD patients with Compound Zhenzhu Tiaozhi capsules;(3) compare the therapeutic effects of Compound Zhenzhu Tiaozhi capsules with conventional medications in the treatment of NAFLD, and to compare their efficacies in improving the risk stratification of ASCVD and quality of life, as assessed by the SF-36; (4) analyze the relationship of Compound Zhenzhu Tiaozhi capsules in improving NAFLD and parameters related to the function of the intestinal mucosal barrier and SIBO.

• Study Type: Interventional
• Enrollment (Anticipated): 196
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xingxiang He, Dr.; Email: hexingxiangtongxun@126.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Recruiting
      • First Affiliated Hospital of Guangdong Pharmaceutical University
      • Contact: Guobiao Huang; Phone Number: 86-20-39352064; Email: 153706227@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

clinical diagnosis of simple steatosis or NASH 18 to 75 years old serum alanine transaminase (ALT)≤2 times the upper limit of normal

Exclusion Criteria:

other chronic liver diseases serious complications in other organs malignant tumors

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: TLC group; transform life custom (TLC) group	Dietary supplement: TLC; transform life custom (TLC)
Active Comparator: TLC + metformin group; transform life custom (TLC) combined with 0.5g metformin, PO tid	Dietary supplement: TLC; transform life custom (TLC); Drug: metformin; 0.5g metformin group，PO tid
Experimental: TLC + CZT capsules group; transform life custom (TLC) combined with 2.52 Compound Zhenzhu Tiaozhi capsules (four tablets), PO tid	Dietary supplement: TLC; transform life custom (TLC); Drug: Compound Zhenzhu Tiaozhi capsule; Compound Zhenzhu Tiaozhi capsules consist of eight Chinese herbal medications, such as Ligustrum lucidum, Atractylodes macrocephala, Radix Salviae Miltiorrhizae, pseudo-ginseng, Astragalus membranaceus.
Active Comparator: TLC + simvastatin group; transform life custom (TLC) combined with 20mg simvastatin, PO qn	Dietary supplement: TLC; transform life custom (TLC); Drug: Simvastatin; 20mg simvastatin, PO qn

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fat attenuation index	The fat attenuation index will be used to assess the therapeutic efficacy. A normal fat attenuation index is defined as < 240 db/m, mild is 240-264 db/m, moderate is 265-294 db/m, and severity is > 295 db/m.We will detect the fat attenuation index at 6 months following treatment. Effective: fat attenuation index is reduced by a level or more (example: moderate to mild). Invalid: fails to meet the effective standard.	at 6 months following therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum triglyceride	detecting the serum level of triglyceride	at 6 months following therapy
Serum cholesterol	detecting the serum level of cholesterol	at 6 months following therapy
Serum lipoproteins	including chylomicron (CM), very-low-density lipoprotein (VLDL), low-density lipoprotein (LDL), and high-density lipoprotein (HDL).	at 6 months following therapy
Hydrogen/methane breath testing	breath testing for SIBO	at 6 months following therapy
Quality of life	The quality of life of the patients before and after treatment will be assessed using the 36-Item Short Form Health Survey and compared to assess the improvement.	at 6 months following therapy

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Guangdong Pharmaceutical University

Study record dates

Study Major Dates

• Study Start (Anticipated): December 31, 2017
• Primary Completion (Anticipated): August 30, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: November 26, 2017
• First Submitted That Met QC Criteria: December 14, 2017
• First Posted (Actual): December 18, 2017

Study Record Updates

• Last Update Posted (Actual): December 19, 2017
• Last Update Submitted That Met QC Criteria: December 18, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Metformin; Simvastatin
• Other Study ID Numbers: U1111-1201-8245

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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