Clinical trial NCT03375580: Therapeutic Effects of Compound Zhenzhu Tiaozhi Capsules in NAFLD
Official title: Therapeutic Effects of Compound Zhenzhu Tiaozhi Capsules in Nonalcoholic Fatty Liver disease-a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nonalcoholic Fatty Liver Disease
Lead sponsor: The First Affiliated Hospital of Guangdong Pharmaceutical University
Sponsor class: OTHER
First posted: 2017-12-18
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Fat attenuation index
timeFrame: at 6 months following therapy
Secondary outcomes:
measure: Serum triglyceride
timeFrame: at 6 months following therapy
measure: Serum cholesterol
timeFrame: at 6 months following therapy
measure: Serum lipoproteins
timeFrame: at 6 months following therapy
measure: Hydrogen/methane breath testing
timeFrame: at 6 months following therapy
measure: Quality of life
timeFrame: at 6 months following therapy
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: First Affiliated Hospital of Guangdong Pharmaceutical University
state: Guangdong
Study officials:
References: