Non-Alcoholic Fatty Liver Disease
Conditions
Keywords
Traditional Chinese Medicine, Brief Fatigue Inventory - Taiwanese Form, FibroScan
Brief 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 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.
Interventions
OTHERChang Geng Healthy Drink
Chang Geng Healthy Drink consists of Zingiberis Rhizoma, Codonopsis pilosula, Atractylodis Macrocephalae Rhizoma, Poria cocos, Citri reticulatae Pericarpium
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue Visual Analogue Scale - Current fatigue level | 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 | 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) | 18 weeks | Aspartate Aminotransferase, Alanine transaminase |
| Liver stiffness measurement (kPa) | 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) | 18 weeks | FibroScan - A Non-invasive Liver Fibrosis Assessment Device. Assess Liver steatosis level (S0 - S3) according to controlled attenuation parameter (CAP) score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinical Significant Adverse Avent (Safety Measures) | 18 weeks | 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 |
Contacts
Primary ContactTse-Hung Huang, MD,PhD
Backup ContactHao-Yun Hsiao, MD
Outcome results
None listed