Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TLC group | Placebo Comparator | transform life custom (TLC) group |
|
| TLC + metformin group | Active Comparator | transform life custom (TLC) combined with 0.5g metformin, PO tid |
|
| TLC + CZT capsules group | Experimental | transform life custom (TLC) combined with 2.52 Compound Zhenzhu Tiaozhi capsules (four tablets), PO tid |
|
| TLC + simvastatin group | Active Comparator | transform life custom (TLC) combined with 20mg simvastatin, PO qn |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TLC | Dietary Supplement | transform life custom (TLC) |
|
| 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 |
| 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 |
Not provided
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
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xingxiang He, Dr. | Contact | hexingxiangtongxun@126.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Guangdong Pharmaceutical University | Recruiting | Guangzhou | Guangdong | 510080 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 11, 2017 | Dec 7, 2017 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 11, 2017 | Dec 7, 2017 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 11, 2017 | Dec 7, 2017 | ICF_002.pdf |
Not provided
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008687 | Metformin |
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D008148 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| metformin | Drug | 0.5g metformin group，PO tid |
|
| Compound Zhenzhu Tiaozhi capsule | Drug | Compound Zhenzhu Tiaozhi capsules consist of eight Chinese herbal medications, such as Ligustrum lucidum, Atractylodes macrocephala, Radix Salviae Miltiorrhizae, pseudo-ginseng, Astragalus membranaceus. |
|
| Simvastatin | Drug | 20mg simvastatin, PO qn |
|
| 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 |
| Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |