Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-25 @ 9:47 PM
Study NCT ID:
NCT04718051
Status:
UNKNOWN
Last Update Posted:
2021-01-22
First Post:
2021-01-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
S.P.PRO LIVER POWDER is Used to Improve Liver and Metabolic Indexes in People With Non-alcoholic Fatty Liver Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008107', 'term': 'Liver Diseases'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-20', 'studyFirstSubmitDate': '2021-01-18', 'studyFirstSubmitQcDate': '2021-01-20', 'lastUpdatePostDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in AST index', 'timeFrame': '36 weeks', 'description': 'Measure the changes in the index which is AST relate to Liver inflammation'}, {'measure': 'Change in ACT index', 'timeFrame': '36 weeks', 'description': 'Measure the changes in the index which is ACT relate to Liver inflammation'}, {'measure': 'Change in HbA1c', 'timeFrame': '36 weeks', 'description': 'Measure the changes in the index which is HbA1c relate to Liver inflammation'}, {'measure': 'Fibroscan', 'timeFrame': '36 weeks', 'description': 'Measure the changes in the index which is Liver Fibrosis'}], 'secondaryOutcomes': [{'measure': 'Measuring Body Mass Index', 'timeFrame': '36 weeks', 'description': 'Measuring Body Mass Index (BMI). Measure the changes in index which is Metabolism'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Liver Diseases']}, 'referencesModule': {'references': [{'pmid': '22095555', 'type': 'BACKGROUND', 'citation': 'Yang MD, Chiang YM, Higashiyama R, Asahina K, Mann DA, Mann J, Wang CC, Tsukamoto H. Rosmarinic acid and baicalin epigenetically derepress peroxisomal proliferator-activated receptor gamma in hepatic stellate cells for their antifibrotic effect. Hepatology. 2012 Apr;55(4):1271-81. doi: 10.1002/hep.24792. Epub 2012 Mar 1.'}]}, 'descriptionModule': {'briefSummary': "With the Westernization of the diet and insufficient exercise, Taiwan's population of obesity, diabetes, and hyperlipidemia has increased in recent years, and the prevalence of the non-alcoholic fatty liver disease has gradually increased. Although weight loss, dietary adjustments, and certain drug treatments can delay the deterioration of the disease; however, weight loss and dietary adjustment are not easy.", 'detailedDescription': "With the Westernization of the diet and insufficient exercise, Taiwan's population of obesity, diabetes, and hyperlipidemia has increased in recent years, and the prevalence of the non-alcoholic fatty liver disease has gradually increased. Although weight loss, dietary adjustments, and certain drug treatments can delay the deterioration of the disease; however, weight loss and dietary adjustment are not easy. Moreover, drugs also have side effects, and there is currently no convenient and effective treatment for people who have non-alcoholic fatty liver disease. The purpose of this trial is that investigating and evaluating the effects on fatty liver, liver fiber, and metabolic indexes after subjects using Shen Pu Yang Gan Wan."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with fatty liver diagnosed by abdominal ultrasound or hepatic fibrometer within half a year's data\n* Subjects with the non-alcoholic fatty liver disease\n* The severity of fatty liver should be at least 3 points by taking an abdominal ultrasound\n\nExclusion Criteria:\n\n* Female patients are pregnant or breastfeeding.\n* Patients with viral hepatitis.\n* Long-term drinkers.\n* Those who use slimming products and vitamin E."}, 'identificationModule': {'nctId': 'NCT04718051', 'briefTitle': 'S.P.PRO LIVER POWDER is Used to Improve Liver and Metabolic Indexes in People With Non-alcoholic Fatty Liver Disease', 'organization': {'class': 'OTHER', 'fullName': 'Taipei Medical University WanFang Hospital'}, 'officialTitle': 'S.P.PRO LIVER POWDER is Used to Improve Liver and Metabolic Indexes in People With Non-alcoholic Fatty Liver Disease', 'orgStudyIdInfo': {'id': 'N202007032'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Shen Pu Yang Gan Wan', 'description': 'Traditional Chinese Medicine', 'interventionNames': ['Drug: Shen Pu Yang Gan Wan']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Comparator', 'description': 'Placebo Comparator', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Shen Pu Yang Gan Wan', 'type': 'DRUG', 'description': 'Shen Pu Yang Gan Wan is Traditional Chinese Medicine; in addition, it has a high dose.', 'armGroupLabels': ['Shen Pu Yang Gan Wan']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Shen Pu Yang Gan Wan is Traditional Chinese Medicine; however, it has a very low dose.', 'armGroupLabels': ['Placebo Comparator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '116', 'city': 'Taipei', 'state': 'Wenshan District', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Ming Shun Wu', 'role': 'CONTACT', 'email': 'mswu@tmu.edu.tw', 'phone': '0229307930', 'phoneExt': '1248'}], 'facility': 'Wanfang Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Ming Shun Wu, PHD', 'role': 'CONTACT', 'email': 'vw1017@gmail.com', 'phone': '+886229307930'}], 'overallOfficials': [{'name': 'Ming Shun Wu', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Taipei Municipal Wanfang Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Medical University WanFang Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sheng Pu Pharmaceutics Co., Ltd.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}