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

Not Applicable

Recruiting

• Conditions: Non-alcoholic Fatty Liver Disease
• Interventions: Other: Jing-Si Herbal Tea; Other: Placebo Jing-Si Herbal Tea

• Registration Number: NCT05858138
• Lead Sponsor: Taichung Tzu Chi Hospital

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 Timeline

• Study Start: 2022-05-03
• Study First Submitted: 2023-04-26
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-12
• Last Update Submitted: 2023-05-12
• Study First Posted: 2023-05-15
• Last Update Posted: 2023-05-15
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 108

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Jing-Si Herbal Tea group	Jing-Si Herbal Tea	Each patient will receive Jing-Si Herbal Tea two times (after breakfast and lunch) in a day for 24 weeks.
Placebo group	Placebo Jing-Si Herbal Tea	Each patient will receive placebo two times (after breakfast and lunch) in a day for 24 weeks.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Taichung Tzu Chi Hospital; 🇨🇳 Taichung, Taiwan