Efficacy Evaluation of Chang Geng Healthy Drink on Patients With Non-alcoholic Fatty Liver Disease

Not Applicable

Not yet recruiting

• Conditions: Non-Alcoholic Fatty Liver Disease
• Interventions: Other: Chang Geng Healthy Drink

• Registration Number: NCT06266559
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-07
• Study Start: 2024-02-15
• Study First Submitted QC: 2024-02-16
• Last Update Submitted: 2024-02-16
• Study First Posted: 2024-02-20
• Last Update Posted: 2024-02-20
• Primary Completion: 2024-03-20
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Initial Drink Group	Chang Geng Healthy Drink	Consume one bottle of Chang Geng Healthy Drink per day for the first eight weeks of the trial.
Subsequent Drink Group	Chang Geng Healthy Drink	Consume one bottle of Chang Geng Healthy Drink per day for the last eight weeks of the trial.

Primary Outcome Measures

Name	Time	Method
Laboratory Data (Linver Function Index)	18 weeks	Aspartate Aminotransferase, Alanine transaminase
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.
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 Outcome Measures

Name	Time	Method
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