Therapeutic Effects of Compound Zhenzhu Tiaozhi Capsules in NAFLD
1 other identifier
interventional
196
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 26, 2017
CompletedFirst Posted
Study publicly available on registry
December 18, 2017
CompletedStudy Start
First participant enrolled
December 31, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedDecember 19, 2017
December 1, 2017
1.7 years
November 26, 2017
December 18, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Serum triglyceride
at 6 months following therapy
Serum cholesterol
at 6 months following therapy
Serum lipoproteins
at 6 months following therapy
Hydrogen/methane breath testing
at 6 months following therapy
Quality of life
at 6 months following therapy
Study Arms (4)
TLC group
PLACEBO COMPARATORtransform life custom (TLC) group
TLC + metformin group
ACTIVE COMPARATORtransform life custom (TLC) combined with 0.5g metformin, PO tid
TLC + CZT capsules group
EXPERIMENTALtransform life custom (TLC) combined with 2.52 Compound Zhenzhu Tiaozhi capsules (four tablets), PO tid
TLC + simvastatin group
ACTIVE COMPARATORtransform life custom (TLC) combined with 20mg simvastatin, PO qn
Interventions
transform life custom (TLC)
Compound Zhenzhu Tiaozhi capsules consist of eight Chinese herbal medications, such as Ligustrum lucidum, Atractylodes macrocephala, Radix Salviae Miltiorrhizae, pseudo-ginseng, Astragalus membranaceus.
Eligibility Criteria
You may qualify if:
- clinical diagnosis of simple steatosis or NASH 18 to 75 years old serum alanine transaminase (ALT)≤2 times the upper limit of normal
You may not qualify if:
- other chronic liver diseases serious complications in other organs malignant tumors
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
First Affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, Guangdong, 510080, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of the Hospital
Study Record Dates
First Submitted
November 26, 2017
First Posted
December 18, 2017
Study Start
December 31, 2017
Primary Completion
August 30, 2019
Study Completion
December 31, 2019
Last Updated
December 19, 2017
Record last verified: 2017-12