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Therapeutic Effects of Compound Zhenzhu Tiaozhi Capsules in NAFLD

NCT ID: NCT03375580

Last Updated: 2017-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

196 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-31

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Nonalcoholic Fatty Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TLC group

transform life custom (TLC) group

Group Type PLACEBO_COMPARATOR

TLC

Intervention Type DIETARY_SUPPLEMENT

transform life custom (TLC)

TLC + metformin group

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

Group Type ACTIVE_COMPARATOR

TLC

Intervention Type DIETARY_SUPPLEMENT

transform life custom (TLC)

metformin

Intervention Type DRUG

0.5g metformin group，PO tid

TLC + CZT capsules group

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

Group Type EXPERIMENTAL

TLC

Intervention Type DIETARY_SUPPLEMENT

transform life custom (TLC)

Compound Zhenzhu Tiaozhi capsule

Intervention Type DRUG

Compound Zhenzhu Tiaozhi capsules consist of eight Chinese herbal medications, such as Ligustrum lucidum, Atractylodes macrocephala, Radix Salviae Miltiorrhizae, pseudo-ginseng, Astragalus membranaceus.

TLC + simvastatin group

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

Group Type ACTIVE_COMPARATOR

TLC

Intervention Type DIETARY_SUPPLEMENT

transform life custom (TLC)

Simvastatin

Intervention Type DRUG

20mg simvastatin, PO qn

Interventions

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TLC

transform life custom (TLC)

Intervention Type DIETARY_SUPPLEMENT

metformin

0.5g metformin group，PO tid

Intervention Type DRUG

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.

Intervention Type DRUG

Simvastatin

20mg simvastatin, PO qn

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital of Guangdong Pharmaceutical University

OTHER

Sponsor Role lead

Responsible Party

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He Xingxiang

Director of the Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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First Affiliated Hospital of Guangdong Pharmaceutical University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xingxiang He, Dr.

Role: CONTACT

Email: [email protected]

Facility Contacts

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Guobiao Huang

Role: primary

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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U1111-1201-8245

Identifier Type: -

Identifier Source: org_study_id