Efficacy Evaluation of Chang Geng Healthy Drink on Patients With Non-alcoholic Fatty Liver Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 主要终点
- Laboratory Data (Linver Function Index)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Initial Drink Group
Consume one bottle of Chang Geng Healthy Drink per day for the first eight weeks of the trial.
干预措施: Chang Geng Healthy Drink (Other)
Subsequent Drink Group
Consume one bottle of Chang Geng Healthy Drink per day for the last eight weeks of the trial.
干预措施: Chang Geng Healthy Drink (Other)
结局指标
主要结局
Laboratory Data (Linver Function Index)
时间窗: 18 weeks
Aspartate Aminotransferase, Alanine transaminase
Fatigue Visual Analogue Scale - Current fatigue level
时间窗: 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
时间窗: 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.
Liver stiffness measurement (kPa)
时间窗: 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)
时间窗: 18 weeks
FibroScan - A Non-invasive Liver Fibrosis Assessment Device. Assess Liver steatosis level (S0 - S3) according to controlled attenuation parameter (CAP) score
次要结局
- Number of Participants With Clinical Significant Adverse Avent (Safety Measures)(18 weeks)
研究者
Tse-Hung Huang
Principal Investigator, Clinical Professor
Chang Gung Memorial Hospital