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

NCT06266559 | Not Yet Recruiting

• 1 other identifier: 202101896A3
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Non-Alcoholic Fatty Liver Disease

Keywords

Traditional Chinese Medicine; Brief Fatigue Inventory - Taiwanese Form; FibroScan

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Number of Participants With Clinical Significant Adverse Avent (Safety Measures)

  18 weeks

Study Arms (2)

Initial Drink Group

EXPERIMENTAL

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

Other: Chang Geng Healthy Drink

Subsequent Drink Group

EXPERIMENTAL

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

Other: Chang Geng Healthy Drink

Interventions

Chang Geng Healthy Drink OTHER

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

Initial Drink Group; Subsequent Drink Group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Central Study Contacts

Tse-Hung Huang, MD,PhD

CONTACT

03-3196200; cgmhtcm@cgmh.org.tw

Hao-Yun Hsiao, MD

CONTACT

03-3196200; hyhsiao@cgmh.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: February 20, 2024
• Study Start: February 15, 2024
• Primary Completion: March 20, 2024
• Study Completion: December 31, 2025
• Last Updated: February 20, 2024

Record last verified: 2024-02