To Explore the Effectiveness of Jing-Si Herbal Tea Against Non-alcoholic Fatty Liver Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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To Explore the Effectiveness of Jing-Si Herbal Tea Against Non-alcoholic Fatty Liver Disease

Conditions
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Non-alcoholic Fatty Liver Disease

Intervention / Treatment
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* Other: Jing-Si Herbal Tea
* Other: Placebo Jing-Si Herbal Tea


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Jing-Si Herbal Tea group<br>Each patient will receive Jing-Si Herbal Tea two times (after breakfast and lunch) in a day for 24 weeks. | Other: Jing-Si Herbal Tea<br>* patient will receive twice in a day for 24 weeks<br>|
| Placebo Comparator: Placebo group<br>Each patient will receive placebo two times (after breakfast and lunch) in a day for 24 weeks. | Other: Placebo Jing-Si Herbal Tea<br>* Placebo Jing-Si Herbal Tea<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessing the changes from baseline blood glucose at 24 week | Collect the data of blood glucose from blood test | 24 week | 
| Assessing the changes from baseline GOT (Glutamic Oxaloacetic Transaminase) at 24 week | Collect the data of GOT from blood test | 24 week | 
| Assessing the changes from baseline GPT (Glutamic Pyruvic Transaminase) at 24 week | Collect the data of GPT from blood test | 24 week | 
| Assessing the changes from baseline total cholesterol at 24 week | Collect the data of total cholesterol from blood test | 24 week | 
| Assessing the changes from baseline triglycerides at 24 week | Collect the data of triglycerides from blood test | 24 week | 
| Assessing the changes from baseline HDL-C at 24 week | Collect the data of HDL-C from blood test | 24 week | 
| Assessing the changes from baseline LDL-C at 24 week | Collect the data of LDL-C from blood test | 24 weekk | 
| Assessing the changes from baseline NAFLD activity at 24 week | Scoring the level of NAFLD activity | 24 week | 
| Assessing the changes from baseline BMI at 24 week | Collect the body height and body weight, weight and height will be combined to report BMI in kg/m^2 | 24 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Jing-Si Herbal Tea