Therapeutic Effects of Compound Zhenzhu Tiaozhi Capsules in NAFLD

Not Applicable

• Conditions: Nonalcoholic Fatty Liver Disease
• Interventions: Dietary Supplement: TLC; Drug: Compound Zhenzhu Tiaozhi capsule; Drug: Simvastatin; Drug: metformin

• Registration Number: NCT03375580
• Lead Sponsor: The First Affiliated Hospital of Guangdong Pharmaceutical University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2017-11-26
• Status Verified: 2017-12
• Study First Submitted QC: 2017-12-14
• Study First Posted: 2017-12-18
• Last Update Submitted: 2017-12-18
• Last Update Posted: 2017-12-19
• Study Start: 2017-12-31
• Primary Completion: 2019-08-30
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 196

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TLC group	TLC	transform life custom (TLC) group
TLC + metformin group	TLC	transform life custom (TLC) combined with 0.5g metformin, PO tid
TLC + CZT capsules group	TLC	transform life custom (TLC) combined with 2.52 Compound Zhenzhu Tiaozhi capsules (four tablets), PO tid
TLC + CZT capsules group	Compound Zhenzhu Tiaozhi capsule	transform life custom (TLC) combined with 2.52 Compound Zhenzhu Tiaozhi capsules (four tablets), PO tid
TLC + simvastatin group	TLC	transform life custom (TLC) combined with 20mg simvastatin, PO qn
TLC + simvastatin group	Simvastatin	transform life custom (TLC) combined with 20mg simvastatin, PO qn
TLC + metformin group	metformin	transform life custom (TLC) combined with 0.5g metformin, PO tid

Primary Outcome Measures

Name	Time	Method
Fat attenuation index	at 6 months following therapy	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.

Secondary Outcome Measures

Name	Time	Method
Serum lipoproteins	at 6 months following therapy	including chylomicron (CM), very-low-density lipoprotein (VLDL), low-density lipoprotein (LDL), and high-density lipoprotein (HDL).
Serum triglyceride	at 6 months following therapy	detecting the serum level of triglyceride
Serum cholesterol	at 6 months following therapy	detecting the serum level of cholesterol
Hydrogen/methane breath testing	at 6 months following therapy	breath testing for SIBO
Quality of life	at 6 months following therapy	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.

Trial Locations

Locations (1)

First Affiliated Hospital of Guangdong Pharmaceutical University; 🇨🇳 Guangzhou, Guangdong, China