Nonalcoholic Fatty Liver Disease
Conditions
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.
Interventions
DIETARY_SUPPLEMENTTLC
transform life custom (TLC)
DRUGmetformin
0.5g metformin group，PO tid
DRUGCompound 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.
DRUGSimvastatin
20mg simvastatin, PO qn
Sponsors
The First Affiliated Hospital of Guangdong Pharmaceutical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Serum lipoproteins | at 6 months following therapy | including chylomicron (CM), very-low-density lipoprotein (VLDL), low-density lipoprotein (LDL), and high-density lipoprotein (HDL). |
| 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. |
Countries
China
Contacts
Primary ContactXingxiang He, Dr.
Outcome results
None listed