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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Non-Alcoholic Fatty Liver Disease
• Intervention / Treatment: Other: Chang Geng Healthy Drink

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tse-Hung Huang, MD,PhD; Phone Number: 2659 03-3196200; Email: cgmhtcm@cgmh.org.tw
• Study Contact Backup: Name: Hao-Yun Hsiao, MD; Phone Number: 5167 03-3196200; Email: hyhsiao@cgmh.org.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Initial Drink Group; Consume one bottle of Chang Geng Healthy Drink per day for the first eight weeks of the trial.	Other: Chang Geng Healthy Drink; Chang Geng Healthy Drink consists of Zingiberis Rhizoma, Codonopsis pilosula, Atractylodis Macrocephalae Rhizoma, Poria cocos, Citri reticulatae Pericarpium
Experimental: Subsequent Drink Group; Consume one bottle of Chang Geng Healthy Drink per day for the last eight weeks of the trial.	Other: Chang Geng Healthy Drink; Chang Geng Healthy Drink consists of Zingiberis Rhizoma, Codonopsis pilosula, Atractylodis Macrocephalae Rhizoma, Poria cocos, Citri reticulatae Pericarpium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): February 15, 2024
• Primary Completion (Estimated): March 20, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: February 7, 2024
• First Submitted That Met QC Criteria: February 16, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Traditional Chinese Medicine; FibroScan; Brief Fatigue Inventory - Taiwanese Form
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: 202101896A3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No