Clinical trial NCT06266559: Efficacy Evaluation of Chang Geng Healthy Drink on Patients With Non-alcoholic Fatty Liver Disease
Official title: Efficacy Evaluation of Chang Geng Healthy Drink on Patients With Non-alcoholic Fatty Liver Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Non-Alcoholic Fatty Liver Disease
Keywords: Traditional Chinese Medicine
Brief Fatigue Inventory - Taiwanese Form
FibroScan
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fatigue Visual Analogue Scale - Current fatigue level
timeFrame: 18 weeks
measure: Fatigue Visual Analogue Scale - Other daily specific task fatigue level
timeFrame: 18 weeks
measure: Laboratory Data (Linver Function Index)
timeFrame: 18 weeks
measure: Liver stiffness measurement (kPa)
timeFrame: 18 weeks
measure: Controlled attenuation parameter (dB/m)
timeFrame: 18 weeks
Secondary outcomes:
measure: Number of Participants With Clinical Significant Adverse Avent (Safety Measures)
timeFrame: 18 weeks
Other outcomes:
Locations:
Study officials:
References: