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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Initial Drink Group | Experimental | Consume one bottle of Chang Geng Healthy Drink per day for the first eight weeks of the trial. |
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| Subsequent Drink Group | Experimental | Consume one bottle of Chang Geng Healthy Drink per day for the last eight weeks of the trial. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chang Geng Healthy Drink | Other | Chang Geng Healthy Drink consists of Zingiberis Rhizoma, Codonopsis pilosula, Atractylodis Macrocephalae Rhizoma, Poria cocos, Citri reticulatae Pericarpium |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 18 weeks |
| Laboratory Data (Linver Function Index) | Aspartate Aminotransferase, Alanine transaminase | 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. | 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 | 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 18 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tse-Hung Huang, MD,PhD | Contact | 03-3196200 | 2659 | cgmhtcm@cgmh.org.tw |
| Hao-Yun Hsiao, MD | Contact | 03-3196200 | 5167 | hyhsiao@cgmh.org.tw |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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