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

• Sponsor: Taichung Tzu Chi Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05858138
• Collaborator: (none)
• Enrollment: 108
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 19.9
• Patients Per Site Per Month: 5.4

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Non-alcoholic Fatty Liver Disease	Other: Jing-Si Herbal Tea; Other: Placebo Jing-Si Herbal Tea	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 108 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: To Explore the Effectiveness of Jing-Si Herbal Tea Against Non-alcoholic Fatty Liver Disease
• Actual Study Start Date: May 3, 2022
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Assessing the changes from baseline blood glucose at 24 week [24 week]

   Collect the data of blood glucose from blood test

2. Assessing the changes from baseline GOT (Glutamic Oxaloacetic Transaminase) at 24 week [24 week]

   Collect the data of GOT from blood test

3. Assessing the changes from baseline GPT (Glutamic Pyruvic Transaminase) at 24 week [24 week]

   Collect the data of GPT from blood test

4. Assessing the changes from baseline total cholesterol at 24 week [24 week]

   Collect the data of total cholesterol from blood test

5. Assessing the changes from baseline triglycerides at 24 week [24 week]

   Collect the data of triglycerides from blood test

6. Assessing the changes from baseline HDL-C at 24 week [24 week]

   Collect the data of HDL-C from blood test

7. Assessing the changes from baseline LDL-C at 24 week [24 weekk]

   Collect the data of LDL-C from blood test

8. Assessing the changes from baseline NAFLD activity at 24 week [24 week]

   Scoring the level of NAFLD activity

9. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Taichung Tzu Chi Hospital	Taichung		Taiwan	42743

Sponsors and Collaborators

• Taichung Tzu Chi Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sheng-Chun Chiu, Principal Investigator, Taichung Tzu Chi Hospital
• ClinicalTrials.gov Identifier: NCT05858138
• Other Study ID Numbers: REC110-74
• First Posted: May 15, 2023
• Last Update Posted: May 15, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sheng-Chun Chiu, Principal Investigator, Taichung Tzu Chi Hospital: Jing-Si Herbal Tea
• Additional relevant MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease

Study Results

No Results Posted as of May 15, 2023