Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT05076058
Status:
UNKNOWN
Last Update Posted:
2021-10-13
First Post:
2021-09-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Tablets of Silybum Marianum, Pueraria Lobate and Salvia Miltiorrhiza on Fatty Liver
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}, {'id': 'D005234', 'term': 'Fatty Liver'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C028972', 'term': 'dan-shen root extract'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Placebo with the same appearance, taste, smell, and packing box to the experimental supplement was used. 118 serial numbers matched to each one participant, and corresponding to study arms (named as 1 or 2 on the tablet box), were used to replace the original label of supplement or placebo after randomization. The code of serial number corresponding to the group code (1 or 2) of tablets was kept by the PI, and will not be disclosed until the completion of all data collection. The group code corresponding to the two types of tablets was/will be kept by the producer till the completion of data analysis.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 118}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-29', 'studyFirstSubmitDate': '2021-09-10', 'studyFirstSubmitQcDate': '2021-09-29', 'lastUpdatePostDateStruct': {'date': '2021-10-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change from baseline body weight at 6 months', 'timeFrame': '0 and 6 months', 'description': 'Body measurement 1: Body weight (in kg)'}, {'measure': 'Change from baseline body height at 6 months', 'timeFrame': '0 and 6 months', 'description': 'Body measurement 2: Body height (in cm)'}, {'measure': 'Change from baseline waist circumference at 6 months', 'timeFrame': '0 and 6 months', 'description': 'Body measurement 3: Waist circumference (in cm)'}, {'measure': 'Change from baseline hip circumference at 6 months', 'timeFrame': '0 and 6 months', 'description': 'Body measurement 4: hip circumference (in cm)'}, {'measure': 'Change from baseline anxiety score at 6 months', 'timeFrame': '0 and 6 months', 'description': 'Anxiety Score: assessed by a Self Rating Anxiety Scale (SAS).the minimum and maximum values: 25-100 points. Higher scores mean worse outcome.'}, {'measure': 'Number of treated events related to supplements between baseline to 6 months', 'timeFrame': '0 and 6 months', 'description': 'Adverse/side effects: Assessed by using questionnaire of medical history, medication use, symptoms.'}, {'measure': 'Percentage of the interventional supplements consumed between baseline to 6 months', 'timeFrame': 'at 6 months', 'description': 'Compliance assessment: Assessed by counting the number of remaining supplemental tablets at 6 months'}], 'primaryOutcomes': [{'measure': 'Change from baseline proton density fat fraction of liver at 6 months', 'timeFrame': '0 and 6 months', 'description': 'Proton density fat fraction of liver: measured using magnetic resonance (MR)'}, {'measure': 'Change from baseline liver fibrosis biomarker (Type pro-collagen III N terminal peptide) at 6 months', 'timeFrame': '0 and 6 months', 'description': 'Liver fibrosis biomarker 1: Type pro-collagen III N terminal peptide'}, {'measure': 'Change from baseline liver fibrosis biomarker (hyaluronic acid) at 6 months', 'timeFrame': '0 and 6 months', 'description': 'Liver fibrosis biomarker 2: hyaluronic acid'}, {'measure': 'Change from baseline liver fibrosis biomarker (laminin) at 6 months', 'timeFrame': '0 and 6 months', 'description': 'Liver fibrosis biomarker 3: laminin'}, {'measure': 'Change from baseline liver fibrosis biomarker (collagen type IV) at 6 months', 'timeFrame': '0 and 6 months', 'description': 'Liver fibrosis biomarker 4: Collagen type IV'}, {'measure': 'Change from baseline liver fibrosis biomarker (glycocholic acid) at 6 months', 'timeFrame': '0 and 6 months', 'description': 'Liver fibrosis biomarker 5: Glycocholic acid'}, {'measure': 'Change from baseline NAFLD fibrosis score at 6 months', 'timeFrame': '0 and 6 months', 'description': 'NAFLD fibrosis score: = -1.675 + 0.037 Age (yrs) + 0.094 BMI (kg/m2) + 1.13 impaired fasting glucose (IFG)/diabetes (yes = 1, no = 0) + 0.99 AST/ALT ratio - 0.013Platelet (\\*10E9/L) - 0.66 Albumin (g/dl)'}], 'secondaryOutcomes': [{'measure': 'Change from baseline liver function biomarker (AST) at 6 months', 'timeFrame': '0 and 6 months', 'description': 'Liver function biomarkers 1: AST'}, {'measure': 'Change from baseline liver function biomarker (ALT) at 6 months', 'timeFrame': '0 and 6 months', 'description': 'Liver function biomarkers 2: serum ALT'}, {'measure': 'Change from baseline liver function biomarker (GGT) at 6 months', 'timeFrame': '0 and 6 months', 'description': 'Liver function biomarkers 3: serum gamma-glutamyl transpeptidase (GGT)'}, {'measure': 'Change from baseline liver function biomarker (total protein) at 6 months', 'timeFrame': '0 and 6 months', 'description': 'Liver function biomarkers 4: serum total protein'}, {'measure': 'Change from baseline liver function biomarker (ALP) at 6 months', 'timeFrame': '0 and 6 months', 'description': 'Liver function biomarkers 5: serum alkaline phosphatase (ALP)'}, {'measure': 'Change from baseline liver function biomarker (bile acids) at 6 months', 'timeFrame': '0 and 6 months', 'description': 'Liver function biomarkers 6: serum bile acids'}, {'measure': 'Change from baseline fasting blood lipid (TG) at 6 months', 'timeFrame': '0 and 6 months', 'description': 'Fasting blood lipid 1: serum triglycerides'}, {'measure': 'Change from baseline fasting blood lipid (TC) at 6 months', 'timeFrame': '0 and 6 months', 'description': 'Fasting blood lipid 2: serum total cholesterol'}, {'measure': 'Change from baseline fasting blood lipid (HDL-C) at 6 months', 'timeFrame': '0 and 6 months', 'description': 'Fasting blood lipid 3: serum high-density lipoprotein cholesterol (HDL-C)'}, {'measure': 'Change from baseline fasting blood lipid (LDL-C) at 6 months', 'timeFrame': '0 and 6 months', 'description': 'Fasting blood lipid 4: serum low-density lipoprotein cholesterol (LDL-C)'}, {'measure': 'Change from baseline fasting blood glucose at 6 months', 'timeFrame': '0 and 6 months', 'description': 'Fasting blood glucose: serum glucose'}, {'measure': 'Change from baseline fasting blood insulin at 6 months', 'timeFrame': '0 and 6 months', 'description': 'Fasting blood insulin: serum insulin'}, {'measure': 'Change from baseline systolic blood pressure at 6 months', 'timeFrame': '0 and 6 months', 'description': 'Blood pressure: systolic blood pressure'}, {'measure': 'Change from baseline diastolic blood pressure at 6 months', 'timeFrame': '0 and 6 months', 'description': 'Blood pressure: diastolic blood pressure'}, {'measure': 'Change from baseline Inflammatory factor (hsCRP ) at 6 months', 'timeFrame': '0 and 6 months', 'description': 'Inflammatory factor 1: serum high sensitivity C reactive protein (hsCRP)'}, {'measure': 'Change from baseline Inflammatory factor (IL-6) at 6 months', 'timeFrame': '0 and 6 months', 'description': 'Inflammatory factor 2: serum IL-6'}, {'measure': 'Change from baseline oxidative stress (SOD) at 6 months', 'timeFrame': '0 and 6 months', 'description': 'Oxidative stress biomarker 1: serum SOD'}, {'measure': 'Change from baseline oxidative stress (MDA) at 6 months', 'timeFrame': '0 and 6 months', 'description': 'Oxidative stress biomarker 2: serum malondialdehyde (MDA)'}, {'measure': 'Change from baseline fat mass at 6 months', 'timeFrame': '0 and 6 months', 'description': 'Fat mass (FM): FM (kg) at total body and sub-regions determined by a dual energy x-ray absorptiometry (DXA)'}, {'measure': 'Change from baseline percentage fat mass at 6 months', 'timeFrame': '0 and 6 months', 'description': 'Percentage Fat mass (%FM): %FM (%) at total body and sub-regions determined by DXA'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fatty liver', 'silybum marianum', 'Pueraria lobate', 'salvia miltiorrhiza'], 'conditions': ['Fatty Liver Disease']}, 'referencesModule': {'references': [{'pmid': '38879879', 'type': 'DERIVED', 'citation': 'Li BY, Xi Y, Liu YP, Wang D, Wang C, Chen CG, Fang XH, Li ZX, Chen YM. Effects of Silybum marianum, Pueraria lobate, combined with Salvia miltiorrhiza tablets on non-alcoholic fatty liver disease in adults: A triple-blind, randomized, placebo-controlled clinical trial. Clin Nutr ESPEN. 2024 Oct;63:2-12. doi: 10.1016/j.clnesp.2024.06.003. Epub 2024 Jun 10.'}]}, 'descriptionModule': {'briefSummary': 'Objectives: To examine the effects of tablets of silybum marianum, Pueraria lobate and salvia miltiorrhiza on the progression of fatty liver in patients with fatty liver.\n\nDesign: a double-blinded randomized placebo-controlled clinical trial.\n\nSetting: community residents, Guangzhou city, South China.\n\nParticipants: a total 118 men and women (18-65 years), with BMI range of 24-30 kg/m2, and with fatty liver screened by ultrasound or MR at baseline.\n\nArms and Interventions: 118 participants were randomly allocated into two arms using a block randomization method. Experimental Arm: tablet of silybum marianum, Pueraria lobate and salvia miltiorrhiza, 3 tablets (1g each) twice a day for 6 months; Placebo Arm: placebo tablets, 3 tablets (1g each) twice a day for 6 months.\n\nOutcome Measures: determined at baseline and at 6 months post treatment\n\n1. Primary Outcome Measures: 1) proton density fat fraction of liver assessed by MR; 2) serum liver fibrosis biomarkers: type procollagen III N terminal peptide, hyaluronic acid, laminin, collagen type IV, and glycocholic acid; 3) NAFLD fibrosis score.\n2. Secondary Outcome Measures: 1) serum liver function biomarkers: AST, ALT, GGT, ALP, total protein, and bile acids; 2) fasting blood lipids: total triglycerides, total cholesterol, HDL cholesterol and LDL cholesterol; 3) fasting serum glucose and insulin; 4) serum inflammatory factors (hsCRP and IL-6); 5) oxidative stress: SOD and MDA; and 6) body measurements and body fat mass.\n\nData Analyses: Mean changes in the above outcome measures from baseline to 6 months will be compared between the two arms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 18-65 years\n* BMI: 24-30 kg/m2\n* Fatty liver, assessed by ultrasound or MR\n* Had normal diet and normal daily life.\n\nExclusion Criteria:\n\n* Hospital confirmed diseases of heart, liver (viral hepatitis, drug-induced liver injury, cirrhosis), kidney, brain, hematopoietic system，diabetes, immune system, and cancer；\n* Taking medicine or supplements known to affect fatty liver, body fat;\n* Body weight had changed more than 10% within the past 3 months;\n* Physical or mental disabled to participate the trial;\n* Compliance of tablet consumption is/was less than 80% in run-in period;\n* Pregnant or lactating women, or intended pregnancy during the trial period;\n* Be allergic to the proposed supplements；\n* Attended or plan to attend other trial(s);\n* Be unwell to sign the informed consent form, or have other conditions that be not suitable to attend the trial considered by the investigators.'}, 'identificationModule': {'nctId': 'NCT05076058', 'briefTitle': 'Effects of Tablets of Silybum Marianum, Pueraria Lobate and Salvia Miltiorrhiza on Fatty Liver', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Effects of Tablets of Silybum Marianum, Pueraria Lobate and Salvia Miltiorrhiza on the Progression of Fatty Liver in Adults: a Double-blinded Randomized Placebo-controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'K19-51000-043'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group', 'description': 'Tablet name: tablet of silybum marianum, Pueraria lobate and salvia miltiorrhiza;\n\nDosage: 1g/tablet, 3 tablets/time；\n\nFrequency: 2 times/day;\n\nDuration: 6 months', 'interventionNames': ['Dietary Supplement: Tablet of silybum marianum, Pueraria lobate and salvia miltiorrhiza']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Tablet name: Placebo;\n\nDosage: 1g/tablet, 3 tablets/time；\n\nFrequency: 2 times/day;\n\nDuration: 6 months', 'interventionNames': ['Other: Placebo tablet']}], 'interventions': [{'name': 'Tablet of silybum marianum, Pueraria lobate and salvia miltiorrhiza', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Brand names: BY-HEALTH；\n\nMain contents (per 100g): silibinin 2g, salvianolic acid B 0.72g，Puerarin 0.68g', 'armGroupLabels': ['Treatment group']}, {'name': 'Placebo tablet', 'type': 'OTHER', 'description': 'Brand names: BY-HEALTH；\n\nMain contents : starch', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yu-ming Chen', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}