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

Chang Gung Medical Foundation

Status: Not yet enrolling

Conditions: Non-Alcoholic Fatty Liver Disease

Treatments: Other: Chang Geng Healthy Drink

Study type: Interventional

Funder types: Other

Identifiers

NCT06266559

202101896A3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Initial Drink Group

Experimental group

Description:

Consume one bottle of Chang Geng Healthy Drink per day for the first eight weeks of the trial.

Treatment:

Other: Chang Geng Healthy Drink

Subsequent Drink Group

Experimental group

Description:

Consume one bottle of Chang Geng Healthy Drink per day for the last eight weeks of the trial.

Treatment:

Other: Chang Geng Healthy Drink