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

The aim of this study is to explore the effectiveness of Jing-Si Herbal Tea on improving the Non-alcoholic fatty liver disease patients

Study Overview

• Status: Completed
• Conditions: Non-alcoholic Fatty Liver Disease
• Intervention / Treatment: Other: Jing-Si Herbal Tea; Other: Placebo Jing-Si Herbal Tea

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 Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taiwan
    • Taichung, Taiwan, Taiwan, 42743
      • Taichung Tzu Chi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Taichung Tzu Chi Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2022
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: April 26, 2023
• First Submitted That Met QC Criteria: May 12, 2023
• First Posted (Actual): May 15, 2023

Study Record Updates

• Last Update Posted (Estimated): September 9, 2025
• Last Update Submitted That Met QC Criteria: September 2, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Jing-Si Herbal Tea
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: REC110-74

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No