Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2025-12-26 @ 1:22 PM
Study NCT ID:
NCT06266559
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-20
First Post:
2024-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Evaluation of Chang Geng Healthy Drink on Patients With Non-alcoholic Fatty Liver Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-02-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-16', 'studyFirstSubmitDate': '2024-02-07', 'studyFirstSubmitQcDate': '2024-02-16', 'lastUpdatePostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fatigue Visual Analogue Scale - Current fatigue level', 'timeFrame': '18 weeks', 'description': 'Brief Fatigue Inventory - Taiwanese Form (BFI-T) with a scale from 0 (least fatigue) to 10 (most fatigue) assessing current fatigue level.'}, {'measure': 'Fatigue Visual Analogue Scale - Other daily specific task fatigue level', 'timeFrame': '18 weeks', 'description': '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.'}, {'measure': 'Laboratory Data (Linver Function Index)', 'timeFrame': '18 weeks', 'description': 'Aspartate Aminotransferase, Alanine transaminase'}, {'measure': 'Liver stiffness measurement (kPa)', 'timeFrame': '18 weeks', 'description': 'FibroScan - A Non-invasive Liver Fibrosis Assessment Device. Assess liver stiffness level (F1 - F4) with liver stiffness measurement (LSM) score.'}, {'measure': 'Controlled attenuation parameter (dB/m)', 'timeFrame': '18 weeks', 'description': 'FibroScan - A Non-invasive Liver Fibrosis Assessment Device. Assess Liver steatosis level (S0 - S3) according to controlled attenuation parameter (CAP) score'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Clinical Significant Adverse Avent (Safety Measures)', 'timeFrame': '18 weeks', 'description': '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'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Traditional Chinese Medicine', 'Brief Fatigue Inventory - Taiwanese Form', 'FibroScan'], 'conditions': ['Non-Alcoholic Fatty Liver Disease']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male and female participants aged between 20 and 75 years old.\n* Capable of understanding and signing the Informed Consent Form (ICF) document.\n* Diagnosed by a physician with non-alcoholic moderate fatty liver.\n* Liver function index, AST or ALT, elevated to 2 to 5 times the normal value for more than 1 month.\n\nExclusion Criteria:\n\n* Diagnosed with alcoholic fatty liver, viral hepatitis, autoimmune hepatitis, Wilson's Disease, drug-induced hepatitis, or hemochromatosis.\n* Currently suffering from major illnesses such as cancer, stroke, end-stage kidney disease, cirrhosis.\n* Men who consume more than 140g of alcohol per week, or women who consume more than 70g of alcohol per week.\n* Consuming other chinese herbal medicine.\n* Pregnant or lactating women.\n* Patients using lipid-lowering and diabetes medications.\n* Patients with Covid-19."}, 'identificationModule': {'nctId': 'NCT06266559', 'briefTitle': 'Efficacy Evaluation of Chang Geng Healthy Drink on Patients With Non-alcoholic Fatty Liver Disease', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Efficacy Evaluation of Chang Geng Healthy Drink on Patients With Non-alcoholic Fatty Liver Disease', 'orgStudyIdInfo': {'id': '202101896A3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Initial Drink Group', 'description': 'Consume one bottle of Chang Geng Healthy Drink per day for the first eight weeks of the trial.', 'interventionNames': ['Other: Chang Geng Healthy Drink']}, {'type': 'EXPERIMENTAL', 'label': 'Subsequent Drink Group', 'description': 'Consume one bottle of Chang Geng Healthy Drink per day for the last eight weeks of the trial.', 'interventionNames': ['Other: Chang Geng Healthy Drink']}], 'interventions': [{'name': 'Chang Geng Healthy Drink', 'type': 'OTHER', 'description': 'Chang Geng Healthy Drink consists of Zingiberis Rhizoma, Codonopsis pilosula, Atractylodis Macrocephalae Rhizoma, Poria cocos, Citri reticulatae Pericarpium', 'armGroupLabels': ['Initial Drink Group', 'Subsequent Drink Group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Tse-Hung Huang, MD,PhD', 'role': 'CONTACT', 'email': 'cgmhtcm@cgmh.org.tw', 'phone': '03-3196200', 'phoneExt': '2659'}, {'name': 'Hao-Yun Hsiao, MD', 'role': 'CONTACT', 'email': 'hyhsiao@cgmh.org.tw', 'phone': '03-3196200', 'phoneExt': '5167'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Clinical Professor', 'investigatorFullName': 'Tse-Hung Huang', 'investigatorAffiliation': 'Chang Gung Memorial Hospital'}}}}