Therapeutic Effects of Compound Zhenzhu Tiaozhi Capsules in NAFLD

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Nonalcoholic Fatty Liver Disease

Intervention / Treatment
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* Dietary Supplement: TLC
* Drug: metformin
* Drug: Compound Zhenzhu Tiaozhi capsule
* Drug: Simvastatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |