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

Non-Alcoholic Fatty Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06266559
• Other study ID #: 202101896A3
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 15, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: Chang Gung Memorial Hospital
• Contact: Tse-Hung Huang, MD,PhD
• Phone: 03-3196200
• Email: cgmhtcm[@]cgmh.org.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 31, 2025
• Est. primary completion date: March 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-Alcoholic Fatty Liver Disease

Intervention

Other:
• Chang Geng Healthy Drink
Chang Geng Healthy Drink consists of Zingiberis Rhizoma, Codonopsis pilosula, Atractylodis Macrocephalae Rhizoma, Poria cocos, Citri reticulatae Pericarpium

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Laboratory Data (Linver Function Index)	Aspartate Aminotransferase, Alanine transaminase	18 weeks
Primary	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
Primary	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	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