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

Non-alcoholic Fatty Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05858138
• Other study ID #: REC110-74
• Status: Recruiting
• Phase: N/A
• Start date: May 3, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2023
• Source: Taichung Tzu Chi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease

Intervention

Other:
• Jing-Si Herbal Tea
patient will receive twice in a day for 24 weeks
• Placebo Jing-Si Herbal Tea
Placebo Jing-Si Herbal Tea

Locations

Country	Name	City	State
Taiwan	Taichung Tzu Chi Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Taichung Tzu Chi Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessing the changes from baseline blood glucose at 24 week	Collect the data of blood glucose from blood test	24 week
Primary	Assessing the changes from baseline GOT (Glutamic Oxaloacetic Transaminase) at 24 week	Collect the data of GOT from blood test	24 week
Primary	Assessing the changes from baseline GPT (Glutamic Pyruvic Transaminase) at 24 week	Collect the data of GPT from blood test	24 week
Primary	Assessing the changes from baseline total cholesterol at 24 week	Collect the data of total cholesterol from blood test	24 week
Primary	Assessing the changes from baseline triglycerides at 24 week	Collect the data of triglycerides from blood test	24 week
Primary	Assessing the changes from baseline HDL-C at 24 week	Collect the data of HDL-C from blood test	24 week
Primary	Assessing the changes from baseline LDL-C at 24 week	Collect the data of LDL-C from blood test	24 weekk
Primary	Assessing the changes from baseline NAFLD activity at 24 week	Scoring the level of NAFLD activity	24 week
Primary	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