NCT05858138

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 3, 2022

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 15, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

September 9, 2025

Status Verified

September 1, 2025

Enrollment Period

2.7 years

First QC Date

April 26, 2023

Last Update Submit

September 2, 2025

Conditions

Keywords

Jing-Si Herbal Tea

Outcome Measures

Primary Outcomes (9)

  • 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

Study Arms (2)

Jing-Si Herbal Tea group

EXPERIMENTAL

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

Placebo group

PLACEBO COMPARATOR

Each patient will receive placebo two times (after breakfast and lunch) in a day for 24 weeks.

Other: Placebo Jing-Si Herbal Tea

Interventions

patient will receive twice in a day for 24 weeks

Jing-Si Herbal Tea group

Placebo Jing-Si Herbal Tea

Placebo group

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sign the Informed consent
  • Age between 20-70
  • Diagnosis for moderated NAFLD
  • Liver disease without hepatic decompensation
  • HbA1c \< = 8.0 %

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taichung Tzu Chi Hospital

Taichung, Taiwan, 42743, Taiwan

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 26, 2023

First Posted

May 15, 2023

Study Start

May 3, 2022

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

September 9, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations