Therapeutic Effects of Compound Zhenzhu Tiaozhi Capsules in Nonalcoholic Fatty Liver disease-a Randomized Controlled Study
Overview
- Phase
- Not Applicable
- Intervention
- TLC
- Conditions
- Nonalcoholic Fatty Liver Disease
- Sponsor
- The First Affiliated Hospital of Guangdong Pharmaceutical University
- Enrollment
- 196
- Locations
- 1
- Primary Endpoint
- Fat attenuation index
- Last Updated
- 8 years ago
Overview
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.
Investigators
He Xingxiang
Director of the Hospital
The First Affiliated Hospital of Guangdong Pharmaceutical University
Eligibility Criteria
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
Arms & Interventions
TLC group
transform life custom (TLC) group
Intervention: TLC
TLC + metformin group
transform life custom (TLC) combined with 0.5g metformin, PO tid
Intervention: TLC
TLC + metformin group
transform life custom (TLC) combined with 0.5g metformin, PO tid
Intervention: metformin
TLC + CZT capsules group
transform life custom (TLC) combined with 2.52 Compound Zhenzhu Tiaozhi capsules (four tablets), PO tid
Intervention: TLC
TLC + CZT capsules group
transform life custom (TLC) combined with 2.52 Compound Zhenzhu Tiaozhi capsules (four tablets), PO tid
Intervention: Compound Zhenzhu Tiaozhi capsule
TLC + simvastatin group
transform life custom (TLC) combined with 20mg simvastatin, PO qn
Intervention: TLC
TLC + simvastatin group
transform life custom (TLC) combined with 20mg simvastatin, PO qn
Intervention: Simvastatin
Outcomes
Primary Outcomes
Fat attenuation index
Time Frame: 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 Outcomes
- Serum triglyceride(at 6 months following therapy)
- Serum cholesterol(at 6 months following therapy)
- Serum lipoproteins(at 6 months following therapy)
- Hydrogen/methane breath testing(at 6 months following therapy)
- Quality of life(at 6 months following therapy)