Non-alcoholic Fatty Liver DiseaseNCT05858138
To Explore the Effectiveness of Jing-Si Herbal Tea Against Non-alcoholic Fatty Liver Disease
A study testing Jing-Si Herbal Tea in people with Non-alcoholic Fatty Liver Disease, run by Taichung Tzu Chi Hospital at 1 site in Taiwan.
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 Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease
- What is being tested?
- Jing-Si Herbal Tea
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 May 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sign the Informed consent
- Age between 20-70
- Diagnosis for moderated NAFLD
- Liver disease without hepatic decompensation
- HbA1c < = 8.0 %
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to explore the effectiveness of Jing-Si Herbal Tea on improving the Non-alcoholic fatty liver disease patients
Read the 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.
- Conditions
- Non-alcoholic Fatty Liver Disease
- Being tested
- Jing-Si Herbal Tea, Placebo Jing-Si Herbal Tea
- Keywords
- Jing-Si Herbal Tea
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jing-Si Herbal TeaOther
patient will receive twice in a day for 24 weeks
Placebo Jing-Si Herbal TeaOther
Placebo Jing-Si Herbal Tea
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo Jing-Si Herbal Tea |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing the changes from baseline blood glucose at 24 week
Collect the data of blood glucose from blood test
Measured: 24 week
Assessing the changes from baseline GOT (Glutamic Oxaloacetic Transaminase) at 24 week
Collect the data of GOT from blood test
Measured: 24 week
Assessing the changes from baseline GPT (Glutamic Pyruvic Transaminase) at 24 week
Collect the data of GPT from blood test
Measured: 24 week
Assessing the changes from baseline total cholesterol at 24 week
Collect the data of total cholesterol from blood test
Measured: 24 week
Assessing the changes from baseline triglycerides at 24 week
Collect the data of triglycerides from blood test
Measured: 24 week
Assessing the changes from baseline HDL-C at 24 week
Collect the data of HDL-C from blood test
Measured: 24 week
Assessing the changes from baseline LDL-C at 24 week
Collect the data of LDL-C from blood test
Measured: 24 weekk
Assessing the changes from baseline NAFLD activity at 24 week
Scoring the level of NAFLD activity
Measured: 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
Measured: 24 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2023
- Study start3 May 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taichung Tzu Chi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheng-Chun Chiu, Taichung Tzu Chi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05858138
- Sponsor's protocol ID
- REC110-74
- Status last verified
- Sep 2025
- First submitted
- 26 Apr 2023
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Explore the Effectiveness of Jing-Si Herbal Tea Against Non-alcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT05858138
- Acronym / sponsor ID
- REC110-74
- Conditions
- Non-alcoholic Fatty Liver Disease
- Keywords
- Jing-Si Herbal Tea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Taichung Tzu Chi HospitalUniversity, hospital or other
- Study start
- 3 May 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 15 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Jing-Si Herbal Tea group | Experimental | Other: Jing-Si Herbal TeaEach patient will receive Jing-Si Herbal Tea two times (after breakfast and lunch) in a day for 24 weeks. |
| Placebo group | Placebo comparator | Other: Placebo Jing-Si Herbal TeaEach patient will receive placebo two times (after breakfast and lunch) in a day for 24 weeks. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Sign the Informed consent
- Age between 20-70
- Diagnosis for moderated NAFLD
- Liver disease without hepatic decompensation
- HbA1c < = 8.0 %
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jing-Si Herbal Teapatient will receive twice in a day for 24 weeks | Other | Jing-Si Herbal Tea group |
| Placebo Jing-Si Herbal TeaPlacebo Jing-Si Herbal Tea | Other | Placebo group |
Primary outcome
Assessing the changes from baseline blood glucose at 24 week
Time frame: 24 week
Collect the data of blood glucose from blood test
Assessing the changes from baseline GOT (Glutamic Oxaloacetic Transaminase) at 24 week
Time frame: 24 week
Collect the data of GOT from blood test
Assessing the changes from baseline GPT (Glutamic Pyruvic Transaminase) at 24 week
Time frame: 24 week
Collect the data of GPT from blood test
Assessing the changes from baseline total cholesterol at 24 week
Time frame: 24 week
Collect the data of total cholesterol from blood test
Assessing the changes from baseline triglycerides at 24 week
Time frame: 24 week
Collect the data of triglycerides from blood test
Assessing the changes from baseline HDL-C at 24 week
Time frame: 24 week
Collect the data of HDL-C from blood test
Assessing the changes from baseline LDL-C at 24 week
Time frame: 24 weekk
Collect the data of LDL-C from blood test
Assessing the changes from baseline NAFLD activity at 24 week
Time frame: 24 week
Scoring the level of NAFLD activity
Assessing the changes from baseline BMI at 24 week
Time frame: 24 week
Collect the body height and body weight, weight and height will be combined to report BMI in kg/m^2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jing-Si Herbal Tea in people with Non-alcoholic Fatty Liver Disease, run by Taichung Tzu Chi Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing the changes from baseline blood glucose at 24 week (time frame: 24 week). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.