Back to resultsTo Explore the Effectiveness of Jing-Si Herbal Tea Against Non-alcoholic Fatty Liver Disease
Primary Purpose
Non-alcoholic Fatty Liver Disease
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Jing-Si Herbal Tea
Placebo Jing-Si Herbal Tea
Sponsored by
About this trial
This is an interventional prevention trial for Non-alcoholic Fatty Liver Disease focused on measuring Jing-Si Herbal Tea
Eligibility Criteria
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
Sites / Locations
- Taichung Tzu Chi HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Jing-Si Herbal Tea group
Placebo group
Arm Description
Each patient will receive Jing-Si Herbal Tea two times (after breakfast and lunch) in a day for 24 weeks.
Each patient will receive placebo two times (after breakfast and lunch) in a day for 24 weeks.
Outcomes
Primary Outcome Measures
Assessing the changes from baseline blood glucose at 24 week
Collect the data of blood glucose from blood test
Assessing the changes from baseline GOT (Glutamic Oxaloacetic Transaminase) at 24 week
Collect the data of GOT from blood test
Assessing the changes from baseline GPT (Glutamic Pyruvic Transaminase) at 24 week
Collect the data of GPT from blood test
Assessing the changes from baseline total cholesterol at 24 week
Collect the data of total cholesterol from blood test
Assessing the changes from baseline triglycerides at 24 week
Collect the data of triglycerides from blood test
Assessing the changes from baseline HDL-C at 24 week
Collect the data of HDL-C from blood test
Assessing the changes from baseline LDL-C at 24 week
Collect the data of LDL-C from blood test
Assessing the changes from baseline NAFLD activity at 24 week
Scoring the level of NAFLD activity
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05858138
Brief Title
To Explore the Effectiveness of Jing-Si Herbal Tea Against Non-alcoholic Fatty Liver Disease
Official Title
To Explore the Effectiveness of Jing-Si Herbal Tea Against Non-alcoholic Fatty Liver Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 3, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taichung Tzu Chi Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-alcoholic Fatty Liver Disease
Keywords
Jing-Si Herbal Tea
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Jing-Si Herbal Tea group
Arm Type
Experimental
Arm Description
Each patient will receive Jing-Si Herbal Tea two times (after breakfast and lunch) in a day for 24 weeks.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Each patient will receive placebo two times (after breakfast and lunch) in a day for 24 weeks.
Intervention Type
Other
Intervention Name(s)
Jing-Si Herbal Tea
Intervention Description
patient will receive twice in a day for 24 weeks
Intervention Type
Other
Intervention Name(s)
Placebo Jing-Si Herbal Tea
Intervention Description
Placebo Jing-Si Herbal Tea
Primary Outcome Measure Information:
Title
Assessing the changes from baseline blood glucose at 24 week
Description
Collect the data of blood glucose from blood test
Time Frame
24 week
Title
Assessing the changes from baseline GOT (Glutamic Oxaloacetic Transaminase) at 24 week
Description
Collect the data of GOT from blood test
Time Frame
24 week
Title
Assessing the changes from baseline GPT (Glutamic Pyruvic Transaminase) at 24 week
Description
Collect the data of GPT from blood test
Time Frame
24 week
Title
Assessing the changes from baseline total cholesterol at 24 week
Description
Collect the data of total cholesterol from blood test
Time Frame
24 week
Title
Assessing the changes from baseline triglycerides at 24 week
Description
Collect the data of triglycerides from blood test
Time Frame
24 week
Title
Assessing the changes from baseline HDL-C at 24 week
Description
Collect the data of HDL-C from blood test
Time Frame
24 week
Title
Assessing the changes from baseline LDL-C at 24 week
Description
Collect the data of LDL-C from blood test
Time Frame
24 weekk
Title
Assessing the changes from baseline NAFLD activity at 24 week
Description
Scoring the level of NAFLD activity
Time Frame
24 week
Title
Assessing the changes from baseline BMI at 24 week
Description
Collect the body height and body weight, weight and height will be combined to report BMI in kg/m^2
Time Frame
24 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Taichung Tzu Chi Hospital
City
Taichung
ZIP/Postal Code
42743
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheng-Chun Chiu
Phone
+886-36060666
Ext
3430
Email
honeyhopes@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
To Explore the Effectiveness of Jing-Si Herbal Tea Against Non-alcoholic Fatty Liver Disease
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