Non-Alcoholic Fatty Liver DiseaseNCT06266559
Efficacy Evaluation of Chang Geng Healthy Drink on Patients With Non-alcoholic Fatty Liver Disease
A study testing Chang Geng Healthy Drink in people with Non-Alcoholic Fatty Liver Disease, run by Chang Gung Memorial Hospital.
Trial summary
For non-alcoholic fatty liver disease, there is currently no effective treatment options. Traditional Chinese medicine (TCM) has a long history of treating liver diseases. However, TCM treatment methods are diverse, and there is currently a lack of high-quality clinical research to confirm the efficacy of Chinese… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- What is being tested?
- Chang Geng Healthy Drink
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2024to 31 Dec 2025
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female participants aged between 20 and 75 years old.
- Capable of understanding and signing the Informed Consent Form (ICF) document.
- Diagnosed by a physician with non-alcoholic moderate fatty liver.
- Liver function index, AST or ALT, elevated to 2 to 5 times the normal value for more than 1 month.
Who cannot join
- Diagnosed with alcoholic fatty liver, viral hepatitis, autoimmune hepatitis, Wilson's Disease, drug-induced hepatitis, or hemochromatosis.
- Currently suffering from major illnesses such as cancer, stroke, end-stage kidney disease, cirrhosis.
- Men who consume more than 140g of alcohol per week, or women who consume more than 70g of alcohol per week.
- Consuming other chinese herbal medicine.
- Pregnant or lactating women.
- Patients using lipid-lowering and diabetes medications.
- Patients with Covid-19.
Trial locations and contacts
No sites are listed yet.
About this study
For non-alcoholic fatty liver disease, there is currently no effective treatment options. Traditional Chinese medicine (TCM) has a long history of treating liver diseases. However, TCM treatment methods are diverse, and there is currently a lack of high-quality clinical research to confirm the efficacy of Chinese herbal medicine. Thereafter, Chang-Gung Healthy Drink which is a TCM based healthy drink may be used to alleviate the clinical adverse event of non-alcoholic fatty liver disease patients.
Read the detailed description
For non-alcoholic fatty liver disease, there is currently no effective treatment method. Some studies suggest that a low-calorie diet, exercise, weight loss, etc., may help alleviate clinical symptoms, but the evidence is inconsistent. Traditional Chinese medicine (TCM) has a long history of treating liver diseases, and the formation of non-alcoholic fatty liver disease may be due to liver depression and blood stasis caused by spleen-stomach disharmony. In treatment, traditional Chinese medicine usually focuses on soothing the liver, promoting qi circulation, activating blood circulation, and resolving blood stasis. However, TCM treatment methods are diverse, and there is currently a lack of high-quality clinical research to confirm the efficacy of Chinese herbal medicine. Thereafter, Chang-Gung Healthy Drink which is a TCM based healthy drink may be used to alleviate the clinical adverse event of non-alcoholic fatty liver disease patients.
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Being tested
- Chang Geng Healthy Drink
- Keywords
- Traditional Chinese Medicine, Brief Fatigue Inventory - Taiwanese Form, FibroScan
- 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.
Chang Geng Healthy DrinkOther
Chang Geng Healthy Drink consists of Zingiberis Rhizoma, Codonopsis pilosula, Atractylodis Macrocephalae Rhizoma, Poria cocos, Citri reticulatae Pericarpium
| Study group | Role | What they receive |
|---|---|---|
| Initial Drink Group | Experimental | Consume one bottle of Chang Geng Healthy Drink per day for the first eight weeks of the trial. Receives: Other: Chang Geng Healthy Drink |
| Subsequent Drink Group | Experimental | Consume one bottle of Chang Geng Healthy Drink per day for the last eight weeks of the trial. Receives: Other: Chang Geng Healthy Drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Visual Analogue Scale - Current fatigue level
Brief Fatigue Inventory - Taiwanese Form (BFI-T) with a scale from 0 (least fatigue) to 10 (most fatigue) assessing current fatigue level.
Measured: 18 weeks
Fatigue Visual Analogue Scale - Other daily specific task fatigue level
Brief Fatigue Inventory - Taiwanese Form (BFI-T) with a scale from 0 (least fatigue) to 10 (most fatigue) assessing other daily specific task fatigue level.
Measured: 18 weeks
Laboratory Data (Linver Function Index)
Aspartate Aminotransferase, Alanine transaminase
Measured: 18 weeks
Liver stiffness measurement (kPa)
FibroScan - A Non-invasive Liver Fibrosis Assessment Device. Assess liver stiffness level (F1 - F4) with liver stiffness measurement (LSM) score.
Measured: 18 weeks
Controlled attenuation parameter (dB/m)
FibroScan - A Non-invasive Liver Fibrosis Assessment Device. Assess Liver steatosis level (S0 - S3) according to controlled attenuation parameter (CAP) score
Measured: 18 weeks
Secondary outcomes (1)
Number of Participants With Clinical Significant Adverse Avent (Safety Measures)
Number of participants with significant adverse event during the trial. Also record the category and severity grade of adverse event according to CTCAE Version 5.0
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start15 Feb 2024 (estimated)
- Primary completion20 Mar 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
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.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tse-Hung Huang, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06266559
- Sponsor's protocol ID
- 202101896A3
- Status last verified
- Feb 2024
- First submitted
- 7 Feb 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Evaluation of Chang Geng Healthy Drink on Patients With Non-alcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT06266559
- Acronym / sponsor ID
- 202101896A3
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Keywords
- Traditional Chinese Medicine, Brief Fatigue Inventory - Taiwanese Form, FibroScan
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 15 Feb 2024 (estimated)
- Primary completion
- 20 Mar 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 20 Feb 2024 (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.
For non-alcoholic fatty liver disease, there is currently no effective treatment options. Traditional Chinese medicine (TCM) has a long history of treating liver diseases. However, TCM treatment methods are diverse, and there is currently a lack of high-quality clinical research to confirm the efficacy of Chinese herbal medicine. Thereafter, Chang-Gung Healthy Drink which is a TCM based healthy drink may be used to alleviate the clinical adverse event of non-alcoholic fatty liver disease patients.
Detailed description
For non-alcoholic fatty liver disease, there is currently no effective treatment method. Some studies suggest that a low-calorie diet, exercise, weight loss, etc., may help alleviate clinical symptoms, but the evidence is inconsistent. Traditional Chinese medicine (TCM) has a long history of treating liver diseases, and the formation of non-alcoholic fatty liver disease may be due to liver depression and blood stasis caused by spleen-stomach disharmony. In treatment, traditional Chinese medicine usually focuses on soothing the liver, promoting qi circulation, activating blood circulation, and resolving blood stasis. However, TCM treatment methods are diverse, and there is currently a lack of high-quality clinical research to confirm the efficacy of Chinese herbal medicine. Thereafter, Chang-Gung Healthy Drink which is a TCM based healthy drink may be used to alleviate the clinical adverse event of non-alcoholic fatty liver disease patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Initial Drink Group | Experimental | Other: Chang Geng Healthy DrinkConsume one bottle of Chang Geng Healthy Drink per day for the first eight weeks of the trial. |
| Subsequent Drink Group | Experimental | Other: Chang Geng Healthy DrinkConsume one bottle of Chang Geng Healthy Drink per day for the last eight weeks of the trial. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female participants aged between 20 and 75 years old.
- Capable of understanding and signing the Informed Consent Form (ICF) document.
- Diagnosed by a physician with non-alcoholic moderate fatty liver.
- Liver function index, AST or ALT, elevated to 2 to 5 times the normal value for more than 1 month.
Key exclusion criteria (7 listed)
- Diagnosed with alcoholic fatty liver, viral hepatitis, autoimmune hepatitis, Wilson's Disease, drug-induced hepatitis, or hemochromatosis.
- Currently suffering from major illnesses such as cancer, stroke, end-stage kidney disease, cirrhosis.
- Men who consume more than 140g of alcohol per week, or women who consume more than 70g of alcohol per week.
- Consuming other chinese herbal medicine.
- Pregnant or lactating 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 |
|---|---|---|
| Chang Geng Healthy DrinkChang Geng Healthy Drink consists of Zingiberis Rhizoma, Codonopsis pilosula, Atractylodis Macrocephalae Rhizoma, Poria cocos, Citri reticulatae Pericarpium | Other | Initial Drink Group, Subsequent Drink Group |
Primary outcome
Fatigue Visual Analogue Scale - Current fatigue level
Time frame: 18 weeks
Brief Fatigue Inventory - Taiwanese Form (BFI-T) with a scale from 0 (least fatigue) to 10 (most fatigue) assessing current fatigue level.
Fatigue Visual Analogue Scale - Other daily specific task fatigue level
Time frame: 18 weeks
Brief Fatigue Inventory - Taiwanese Form (BFI-T) with a scale from 0 (least fatigue) to 10 (most fatigue) assessing other daily specific task fatigue level.
Laboratory Data (Linver Function Index)
Time frame: 18 weeks
Aspartate Aminotransferase, Alanine transaminase
Liver stiffness measurement (kPa)
Time frame: 18 weeks
FibroScan - A Non-invasive Liver Fibrosis Assessment Device. Assess liver stiffness level (F1 - F4) with liver stiffness measurement (LSM) score.
Controlled attenuation parameter (dB/m)
Time frame: 18 weeks
FibroScan - A Non-invasive Liver Fibrosis Assessment Device. Assess Liver steatosis level (S0 - S3) according to controlled attenuation parameter (CAP) score
1 secondary outcome
Number of Participants With Clinical Significant Adverse Avent (Safety Measures)
Time frame: 18 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Chang Geng Healthy Drink in people with Non-Alcoholic Fatty Liver Disease, run by Chang Gung Memorial Hospital.
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tse-Hung Huang, MD,PhD (03-3196200 ext. 2659, cgmhtcm@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Visual Analogue Scale - Current fatigue level (time frame: 18 weeks). The study lists 5 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 20 Feb 2024.