Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT06167902
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-13
First Post:
2023-11-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Metabolic Effects of Ginseng Oligopeptide Preparation on Non- Alcoholic Fatty Liver Disease With Obesity: a Randomized Controlled Double-blind Trial
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000713447', 'term': 'Asian ginseng'}, {'id': 'C008315', 'term': 'maltodextrin'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-12-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2025-12-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-11', 'studyFirstSubmitDate': '2023-11-29', 'studyFirstSubmitQcDate': '2023-12-11', 'lastUpdatePostDateStruct': {'date': '2023-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Alanine aminotransferase (ALT)', 'timeFrame': 'The day of enrollment, day 60 and day 120 after enrollment.', 'description': 'Liver function'}, {'measure': 'aspartate aminotransferase (AST)', 'timeFrame': 'The day of enrollment, day 60 and day 120 after enrollment.', 'description': 'Liver function'}, {'measure': 'glutamyltransferase (GGT).', 'timeFrame': 'The day of enrollment, day 60 and day 120 after enrollment.', 'description': 'Liver function'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-alcoholic Fatty Liver Disease']}, 'descriptionModule': {'briefSummary': 'To investigate the effect of ginseng oligopeptide on nonalcoholic fatty liver disease with obesity and clarify its intervention mechanism in theory, which will contribute to the prevention and treatment of non-alcoholic fatty liver more scientifically and effectively.The patients were randomly divided into two groups. One group of patients took ginseng oligopeptide orally, and the other group took placebo. The liver function, blood lipid, blood glucose, liver B ultrasound and other indicators were observed to further determine the efficacy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meet the diagnostic criteria for non-alcoholic fatty liver disease ;\n* Aged 18-65 years old;\n* ALT, AST, GGT≤2×Upper Limit Of Normal（ULN）;\n* BMI≥28Kg/㎡;\n* Patients signed the relevant informed consent on a voluntary basis.\n\nExclusion Criteria:\n\n* Under 18 years old and over 65 years old;\n* Allergic to the ingredients of ginseng oligopeptide preparation;\n* Serum ALT, AST, GGT\\>2ULN;\n* Currently taking oral hepatoprotective drugs such as reduced glutathione, polyene phosphatidylcholine, and silibinin, etc.;\n* Subjects participating in other clinical trials;\n* Pregnant or lactating women;\n* Complicated with serious diseases of the digestive system or other systems, such as chronic gastrointestinal diseases and chronic diseases causing digestive malabsorption,Kidney disease, hematological system or autoimmune diseases;\n* Other populations that were deemed by the investigators to be ineligible for the trial may reduce or complicate enrollment patients with chemotherapy.'}, 'identificationModule': {'nctId': 'NCT06167902', 'briefTitle': 'The Metabolic Effects of Ginseng Oligopeptide Preparation on Non- Alcoholic Fatty Liver Disease With Obesity: a Randomized Controlled Double-blind Trial', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'The Metabolic Effects of Ginseng Oligopeptide Preparation on Non- Alcoholic Fatty Liver Disease With Obesity: a Randomized Controlled Double-blind Trial', 'orgStudyIdInfo': {'id': 'Ginseng oligopeptide 1.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ginseng oligopeptide group', 'interventionNames': ['Other: Ginseng oligopeptide (Ginseng extract）']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'The placebo group', 'interventionNames': ['Other: Maltodextrin']}], 'interventions': [{'name': 'Ginseng oligopeptide (Ginseng extract）', 'type': 'OTHER', 'description': 'The experimental group was given ginseng oligopeptide preparation 1.2g per day orally.', 'armGroupLabels': ['Ginseng oligopeptide group']}, {'name': 'Maltodextrin', 'type': 'OTHER', 'description': 'The control group was treated with placebo maltodextrin 1.2g/d', 'armGroupLabels': ['The placebo group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Wei Chen, Doctor', 'role': 'CONTACT', 'email': 'txchenwei@sina.com', 'phone': '13911006820'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}