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Therapeutic Effects of Compound Zhenzhu Tiaozhi Capsules in NAFLD

Primary Purpose

Nonalcoholic Fatty Liver Disease

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
TLC
metformin
Compound Zhenzhu Tiaozhi capsule
Simvastatin
Sponsored by
The First Affiliated Hospital of Guangdong Pharmaceutical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nonalcoholic Fatty Liver Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • First Affiliated Hospital of Guangdong Pharmaceutical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Experimental

Active Comparator

Arm Label

TLC group

TLC + metformin group

TLC + CZT capsules group

TLC + simvastatin group

Arm Description

transform life custom (TLC) group

transform life custom (TLC) combined with 0.5g metformin, PO tid

transform life custom (TLC) combined with 2.52 Compound Zhenzhu Tiaozhi capsules (four tablets), PO tid

transform life custom (TLC) combined with 20mg simvastatin, PO qn

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Serum triglyceride
detecting the serum level of triglyceride
Serum cholesterol
detecting the serum level of cholesterol
Serum lipoproteins
including chylomicron (CM), very-low-density lipoprotein (VLDL), low-density lipoprotein (LDL), and high-density lipoprotein (HDL).
Hydrogen/methane breath testing
breath testing for SIBO
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.

Full Information

First Posted
November 26, 2017
Last Updated
December 18, 2017
Sponsor
The First Affiliated Hospital of Guangdong Pharmaceutical University
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1. Study Identification

Unique Protocol Identification Number
NCT03375580
Brief Title
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

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 31, 2017 (Anticipated)
Primary Completion Date
August 30, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital of Guangdong Pharmaceutical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonalcoholic Fatty Liver Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
196 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TLC group
Arm Type
Placebo Comparator
Arm Description
transform life custom (TLC) group
Arm Title
TLC + metformin group
Arm Type
Active Comparator
Arm Description
transform life custom (TLC) combined with 0.5g metformin, PO tid
Arm Title
TLC + CZT capsules group
Arm Type
Experimental
Arm Description
transform life custom (TLC) combined with 2.52 Compound Zhenzhu Tiaozhi capsules (four tablets), PO tid
Arm Title
TLC + simvastatin group
Arm Type
Active Comparator
Arm Description
transform life custom (TLC) combined with 20mg simvastatin, PO qn
Intervention Type
Dietary Supplement
Intervention Name(s)
TLC
Intervention Description
transform life custom (TLC)
Intervention Type
Drug
Intervention Name(s)
metformin
Intervention Description
0.5g metformin group,PO tid
Intervention Type
Drug
Intervention Name(s)
Compound Zhenzhu Tiaozhi capsule
Intervention Description
Compound Zhenzhu Tiaozhi capsules consist of eight Chinese herbal medications, such as Ligustrum lucidum, Atractylodes macrocephala, Radix Salviae Miltiorrhizae, pseudo-ginseng, Astragalus membranaceus.
Intervention Type
Drug
Intervention Name(s)
Simvastatin
Intervention Description
20mg simvastatin, PO qn
Primary Outcome Measure Information:
Title
Fat attenuation index
Description
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.
Time Frame
at 6 months following therapy
Secondary Outcome Measure Information:
Title
Serum triglyceride
Description
detecting the serum level of triglyceride
Time Frame
at 6 months following therapy
Title
Serum cholesterol
Description
detecting the serum level of cholesterol
Time Frame
at 6 months following therapy
Title
Serum lipoproteins
Description
including chylomicron (CM), very-low-density lipoprotein (VLDL), low-density lipoprotein (LDL), and high-density lipoprotein (HDL).
Time Frame
at 6 months following therapy
Title
Hydrogen/methane breath testing
Description
breath testing for SIBO
Time Frame
at 6 months following therapy
Title
Quality of life
Description
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.
Time Frame
at 6 months following therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xingxiang He, Dr.
Email
hexingxiangtongxun@126.com
Facility Information:
Facility Name
First Affiliated Hospital of Guangdong Pharmaceutical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guobiao Huang
Phone
86-20-39352064
Email
153706227@qq.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Therapeutic Effects of Compound Zhenzhu Tiaozhi Capsules in NAFLD

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