To Explore the Effectiveness of Jing-Si Herbal Tea Against Non-alcoholic Fatty Liver Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 108
- Locations
- 1
- Primary Endpoint
- Assessing the changes from baseline NAFLD activity at 24 week
Study Overview
Brief Summary
The aim of this study is to explore the effectiveness of Jing-Si Herbal Tea on improving the Non-alcoholic fatty liver disease patients
Detailed Description
This study adopted a randomized double-blind design, 2-arm trial study. All eligible patients included in the study agreed to participated and signed the informed consent from and the study procedures were approved by the ethical committee of Taichung Tzu Chi general hospital (REC110-74). Patients were recruited from the Gastroenterology department of Taichung Tzu Chi hospital. After random assignment to 2 groups, patients will receive Jing-Si Herbal Tea or placebo twice a day for 24 weeks. We will evaluate the blood test results, abdominal ultrasound and physical examination every 12 weeks.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Sign the Informed consent
- •Age between 20-70
- •Diagnosis for moderated NAFLD
- •Liver disease without hepatic decompensation
- •HbA1c < = 8.0 %
Exclusion Criteria
- •Do not sign the Informed consent
- •Other related liver diseases will affect the study which evaluated by physicians
- •Women of potential pregnancy or pregnant women
Outcomes
Primary Outcomes
Assessing the changes from baseline NAFLD activity at 24 week
Time Frame: 24 week
Scoring the level of NAFLD activity
Assessing the changes from baseline blood glucose at 24 week
Time Frame: 24 week
Collect the data of blood glucose from blood test
Assessing the changes from baseline GPT (Glutamic Pyruvic Transaminase) at 24 week
Time Frame: 24 week
Collect the data of GPT from blood test
Assessing the changes from baseline GOT (Glutamic Oxaloacetic Transaminase) at 24 week
Time Frame: 24 week
Collect the data of GOT from blood test
Assessing the changes from baseline HDL-C at 24 week
Time Frame: 24 week
Collect the data of HDL-C from blood test
Assessing the changes from baseline total cholesterol at 24 week
Time Frame: 24 week
Collect the data of total cholesterol from blood test
Assessing the changes from baseline triglycerides at 24 week
Time Frame: 24 week
Collect the data of triglycerides from blood test
Assessing the changes from baseline LDL-C at 24 week
Time Frame: 24 weekk
Collect the data of LDL-C from blood test
Assessing the changes from baseline BMI at 24 week
Time Frame: 24 week
Collect the body height and body weight, weight and height will be combined to report BMI in kg/m\^2
Secondary Outcomes
No secondary outcomes reported
Investigators
Sheng-Chun Chiu
Principal Investigator
Taichung Tzu Chi Hospital