Therapeutic Effects of Compound Zhenzhu Tiaozhi Capsules in NAFLD

Nonalcoholic Fatty Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03375580
• Other study ID #: U1111-1201-8245
• Status: Recruiting
• Phase: N/A
• First received: November 26, 2017
• Last updated: December 18, 2017
• Start date: December 31, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: December 2017
• Source: The First Affiliated Hospital of Guangdong Pharmaceutical University
• Contact: Xingxiang He, Dr.
• Email: hexingxiangtongxun[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 196
• Est. completion date: December 31, 2019
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Fatty Liver Disease

Intervention

Dietary Supplement:
• TLC
transform life custom (TLC)

Drug:
• metformin
0.5g metformin group,PO tid
• Compound 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.
• Simvastatin
20mg simvastatin, PO qn

Locations

Country	Name	City	State
China	First Affiliated Hospital of Guangdong Pharmaceutical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Guangdong Pharmaceutical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Serum triglyceride	detecting the serum level of triglyceride	at 6 months following therapy
Secondary	Serum cholesterol	detecting the serum level of cholesterol	at 6 months following therapy
Secondary	Serum lipoproteins	including chylomicron (CM), very-low-density lipoprotein (VLDL), low-density lipoprotein (LDL), and high-density lipoprotein (HDL).	at 6 months following therapy
Secondary	Hydrogen/methane breath testing	breath testing for SIBO	at 6 months following therapy
Secondary	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