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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06266559
Other study ID # 202101896A3
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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