[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653721":3},{"organization":4,"outcomesModule":7,"designInfo":97,"detailedDescription":103,"studyPopulation":96,"armGroups":104,"interventions":121,"overallOfficials":96,"centralContacts":131,"locations":137,"responsibleParty":196,"collaborators":200,"id":203,"slug":204,"hasResults":205,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":96,"eligibilityCriteria":209,"healthyVolunteers":205,"sex":210,"minAge":211,"maxAge":212,"enrollmentInfo":213,"targetDuration":96,"studyType":216,"phases":217,"briefSummary":219,"conditions":220,"keywords":96,"overallStatus":222,"whyStopped":96,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":232},{"fullName":5,"class":6},"Liaquat University of Medical & Health Sciences","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":96},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline","Change in serum LDL-C concentration from baseline to the end of treatment. The primary analysis will assess the non-inferiority of Berberol® P compared with Berberol® K in reducing LDL-C.","Baseline to Week 12",[14,17,20,23,26,29,32,35,38,41,44,47,50,53,56,59,62,65,68,71,74,77,80,83,86,90,93],{"measure":15,"description":16,"timeFrame":12},"Change in Total Cholesterol From Baseline","Change in serum total cholesterol concentration from baseline to the end of the 12-week treatment period.",{"measure":18,"description":19,"timeFrame":12},"Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline","Change in serum HDL-C concentration from baseline to the end of the 12-week treatment period.",{"measure":21,"description":22,"timeFrame":12},"Change in Triglycerides From Baseline","Change in serum triglyceride concentration from baseline to the end of the 12-week treatment period.",{"measure":24,"description":25,"timeFrame":12},"Change in Fasting Blood Glucose From Baseline","Change in fasting blood glucose concentration (mg\u002FdL) from baseline to the end of treatment.",{"measure":27,"description":28,"timeFrame":12},"Change in Glycated Hemoglobin (HbA1c) From Baseline","Change in HbA1c (%) from baseline to the end of the 12-week treatment period.",{"measure":30,"description":31,"timeFrame":12},"Change in Fasting Insulin From Baseline","Change in fasting serum insulin concentration from baseline to the end of the 12-week treatment period.",{"measure":33,"description":34,"timeFrame":12},"Change in Systolic Blood Pressure From Baseline","Change in systolic blood pressure (mmHg) from baseline to the end of the 12-week treatment period.",{"measure":36,"description":37,"timeFrame":12},"Change in Diastolic Blood Pressure From Baseline","Change in diastolic blood pressure (mmHg) from baseline to the end of the 12-week treatment period.",{"measure":39,"description":40,"timeFrame":12},"Change in Heart Rate From Baseline","Change in heart rate (beats per minute) from baseline to the end of the 12-week treatment period.",{"measure":42,"description":43,"timeFrame":12},"Incidence of Adverse Events","Number and proportion of participants experiencing adverse events during the 12-week treatment period.",{"measure":45,"description":46,"timeFrame":12},"Change in Safety Laboratory Parameters From Baseline","Change from baseline to Week 12 in safety laboratory parameters, including aspartate aminotransferase (AST), alanine aminotransferase (ALT), creatine phosphokinase (CPK), C-reactive protein (CRP), and creatinine.",{"measure":48,"description":49,"timeFrame":12},"Change in Body Weight From Baseline","Change in body weight (kg) from baseline to the end of the 12-week treatment period.",{"measure":51,"description":52,"timeFrame":12},"Change in Waist Circumference From Baseline","Change in waist circumference (cm) from baseline to the end of the 12-week treatment period.",{"measure":54,"description":55,"timeFrame":12},"Change in Non-HDL Cholesterol From Baseline","Change in calculated non-HDL cholesterol concentration from baseline to the end of the 12-week treatment period.",{"measure":57,"description":58,"timeFrame":12},"Change in Very-Low-Density Lipoprotein (VLDL) Cholesterol From Baseline","Change in calculated VLDL cholesterol concentration (mg\u002FdL) from baseline to the end of the 12-week treatment period.",{"measure":60,"description":61,"timeFrame":12},"Change in Total Cholesterol to HDL Cholesterol Ratio (TC\u002FHDL) From Baseline","Change in calculated total cholesterol to HDL cholesterol ratio (TC\u002FHDL) from baseline to the end of the 12-week treatment period.",{"measure":63,"description":64,"timeFrame":12},"Change in LDL Cholesterol to HDL Cholesterol Ratio (LDL\u002FHDL) From Baseline","Change in calculated LDL cholesterol to HDL cholesterol ratio (LDL\u002FHDL) from baseline to the end of the 12-week treatment period.",{"measure":66,"description":67,"timeFrame":12},"Change in Triglyceride to HDL Cholesterol Ratio (TG\u002FHDL) From Baseline","Change in calculated triglyceride to HDL cholesterol ratio (TG\u002FHDL) from baseline to the end of the 12-week treatment period.",{"measure":69,"description":70,"timeFrame":12},"Change in Remnant Cholesterol From Baseline","Change in calculated remnant cholesterol concentration from baseline to the end of the 12-week treatment period.",{"measure":72,"description":73,"timeFrame":12},"Change in Apolipoprotein A1 (Apo A1) From Baseline","Change in Apo A1 concentration from baseline to the end of the 12-week treatment period.",{"measure":75,"description":76,"timeFrame":12},"Change in Apolipoprotein B (ApoB) From Baseline","Change in ApoB concentration (mg\u002FdL) from baseline to the end of the 12-week treatment period.",{"measure":78,"description":79,"timeFrame":12},"Change in Apolipoprotein B to Apolipoprotein A1 Ratio (ApoB\u002FApo A1) From Baseline","Change in the calculated ApoB\u002FApo A1 ratio from baseline to the end of the 12-week treatment period.",{"measure":81,"description":82,"timeFrame":12},"Severity of Undesirable Symptoms","Severity of undesirable symptoms during treatment, including myalgias, cramps, nausea, diarrhea, constipation, abdominal pain, asthenia, and headache, assessed by participants on a 0 to 10 scale, where 0 indicates \"no problem\" and 10 indicates \"very severe problem,\" based on symptoms experienced during the previous 7 days.",{"measure":84,"description":85,"timeFrame":12},"Frequency of Undesirable Symptoms","Frequency of undesirable symptoms, including myalgias, cramps, nausea, diarrhea, constipation, abdominal pain, asthenia, and headache. For each symptom present, participants will report its frequency as occasional, intermittent, or daily.",{"measure":87,"description":88,"timeFrame":89},"Participant-Reported Treatment Tolerability Score on a 0-10 Scale","Treatment tolerability will be assessed by participants at Week 12 using the protocol-defined 0-10 numerical rating scale and recorded in the case report form (CRF).","Week 12",{"measure":91,"description":92,"timeFrame":89},"Participant-Reported Treatment Adherence Percentage","Treatment adherence will be assessed at Week 12 using the protocol-defined 0-100% adherence scale recorded in the CRF.",{"measure":94,"description":95,"timeFrame":89},"Treatment Adherence Based on Returned Unused Tablets","Treatment adherence will be assessed at Week 12 based on the number of unused study tablets returned by participants at the end of the treatment period.",null,{"allocation":98,"interventionModel":99,"interventionModelDescription":96,"primaryPurpose":100,"observationalModel":96,"timePerspective":96,"maskingInfo":101},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":102,"maskingDescription":96,"whoMasked":96},"NONE","Hypercholesterolaemia is an important modifiable cardiovascular risk factor. Nutraceutical approaches may provide an option for individuals with mild-to-moderate hypercholesterolaemia, particularly when lifestyle measures alone are insufficient.\n\nThis is a randomized, controlled, multicentre, three-arm clinical trial evaluating two daily doses of Berberol® P compared with Berberol® K. Eligible participants will be randomized in a 1:1:1 ratio to one of three treatment groups: Berberol® P 1 tablet daily, Berberol® P 2 tablets daily, or Berberol® K 1 tablet daily. Treatment will continue for 12 weeks.\n\nThe primary objective is to evaluate the non-inferiority of Berberol® P compared with Berberol® K with respect to the change in LDL-C after 12 weeks of treatment. The study will also evaluate effects on the lipid profile, glucose metabolism, anthropometric parameters and blood pressure, as well as the safety and tolerability of the interventions.\n\nA total of 255 participants are planned to be enrolled across multiple study centres.",[105,111,115],{"label":106,"type":107,"description":108,"interventionNames":109},"Berberol® P - 1 Tablet Daily","EXPERIMENTAL","Participants will receive Berberol® P 1 tablet once daily after dinner for 12 weeks.",[110],"Dietary Supplement: Berberol® P (manufacturer: PharmExtracta S.p.A.)",{"label":112,"type":107,"description":113,"interventionNames":114},"Berberol P® - 2 Tablets Daily","Participants will receive Berberol® P 2 tablets daily, with 1 tablet after breakfast and 1 tablet after dinner, for 12 weeks.",[110],{"label":116,"type":117,"description":118,"interventionNames":119},"Berberol K® - 1 Tablet Daily","ACTIVE_COMPARATOR","Participants will receive Berberol® K 1 tablet once daily after dinner for 12 weeks.",[120],"Dietary Supplement: Berberol® K (manufacturer: PharmExtracta S.p.A.)",[122,127],{"type":123,"name":124,"description":125,"armGroupLabels":126,"otherNames":96},"DIETARY_SUPPLEMENT","Berberol® P (manufacturer: PharmExtracta S.p.A.)","Dietary supplement containing Berberine Phytosome® and Pycrinil®. Participants receive either 1 tablet daily after dinner or 2 tablets daily (1 after breakfast and 1 after dinner) for 12 weeks, according to the assigned treatment arm.",[112,106],{"type":123,"name":128,"description":129,"armGroupLabels":130,"otherNames":96},"Berberol® K (manufacturer: PharmExtracta S.p.A.)","Dietary supplement containing Berberine Phytosome® and monacolins from fermented red yeast rice. Participants receive 1 tablet daily after dinner for 12 weeks.",[116],[132],{"name":133,"role":134,"phone":135,"phoneExt":96,"email":136},"Prof. Davide Sisti, PhD","CONTACT","+39 0722 303301","davide.sisti@uniurb.it",[138,155,169,182],{"facility":139,"status":96,"city":140,"state":141,"zip":142,"country":143,"countryCode":144,"cosmosGeoPoint":145,"geoPoint":150,"contacts":151},"Poliambulatorio Health","Piacenza","Emilia-Romagna","29122","Italy","IT",{"type":146,"coordinates":147},"Point",[148,149],9.69342,45.05242,{"lat":149,"lon":148},[152],{"name":153,"role":134,"phone":96,"phoneExt":96,"email":154},"Giuliana Rapacioli, MD","giuly.rapacioli@gmail.com",{"facility":156,"status":96,"city":157,"state":158,"zip":159,"country":143,"countryCode":144,"cosmosGeoPoint":160,"geoPoint":164,"contacts":165},"Euromed","Guidonia Montecelio","Lazio","00012",{"type":146,"coordinates":161},[162,163],12.72238,41.99362,{"lat":163,"lon":162},[166],{"name":167,"role":134,"phone":96,"phoneExt":96,"email":168},"Luciano Arcari, MD","lulalug4@gmail.com",{"facility":170,"status":96,"city":171,"state":158,"zip":172,"country":143,"countryCode":144,"cosmosGeoPoint":173,"geoPoint":177,"contacts":178},"Endomed","Rome","00152",{"type":146,"coordinates":174},[175,176],12.51133,41.89193,{"lat":176,"lon":175},[179],{"name":180,"role":134,"phone":96,"phoneExt":96,"email":181},"Paolo Falasca, MD","p.falasca@yahoo.it",{"facility":183,"status":96,"city":184,"state":185,"zip":186,"country":143,"countryCode":144,"cosmosGeoPoint":187,"geoPoint":191,"contacts":192},"University of Urbino Carlo Bo","Urbino","The Marches","61029",{"type":146,"coordinates":188},[189,190],12.63633,43.72621,{"lat":190,"lon":189},[193],{"name":194,"role":134,"phone":96,"phoneExt":96,"email":195},"Giordano Zonzini, MD","giordanozonzini@gmail.com",{"type":197,"investigatorFullName":198,"investigatorTitle":199,"investigatorAffiliation":5,"oldNameTitle":96,"oldOrganization":96},"PRINCIPAL_INVESTIGATOR","Dr. Amjad Khan","Professor of Clinical Biochemistry and Experimental Medicine",[201],{"name":202,"class":6},"University of Urbino \"Carlo Bo\"","100653721","berberol-p-for-mild-to-moderate-hypercholesterolaemia-100653721",false,"NCT07789366","Berberol P for Mild-to-Moderate Hypercholesterolaemia","A Randomized, Controlled, Multicentre, Three-Arm Clinical Trial to Evaluate the Efficacy and Safety of Berberol® P Compared With Berberol® K in Adults With Mild-to-Moderate Hypercholesterolaemia","Inclusion Criteria:\n\n* Age 18-70 years\n* Male or female\n* LDL-C 115-190 mg\u002FdL and\u002For total cholesterol 200-260 mg\u002FdL\n* Triglycerides \\\u003C400 mg\u002FdL\n* Willingness to maintain stable diet and physical activity\n* Written informed consent for study participation obtained prior to the start of the study\n\nExclusion Criteria:\n\n* Use of statins, ezetimibe, fibrates, PCSK9 inhibitors, or lipid-lowering nutraceuticals within 30 days prior to enrollment\n* Uncontrolled diabetes\n* Significant liver or kidney disease\n* Pregnancy or breastfeeding\n* Known intolerance to any component of the study products\n* Recent cardiovascular events\n* Alcohol or drug abuse\n* Participation in another clinical trial within 30 days prior to enrollment\n* Lack of written informed consent","ALL","18 Years","70 Years",{"count":214,"type":215},255,"ESTIMATED","INTERVENTIONAL",[218],"NA","This randomized, controlled, multicentre clinical trial will evaluate the efficacy and safety of Berberol® P compared with Berberol® K in adults with mild-to-moderate hypercholesterolaemia.\n\nA total of 255 participants will be randomized in a 1:1:1 ratio to receive Berberol® P 1 tablet daily, Berberol® P 2 tablets daily, or Berberol® K 1 tablet daily for 12 weeks. The study will primarily assess whether Berberol® P is non-inferior to Berberol® K in reducing low-density lipoprotein cholesterol (LDL-C). Changes in other lipid parameters, glucose metabolism, anthropometric measures, blood pressure, and safety will also be evaluated.",[221],"Hypercholesterolemia","NOT_YET_RECRUITING","2026-08-25",{"date":225,"type":226},"2026-08-27","ACTUAL",{"date":228,"type":215},"2026-09-07",{"date":230,"type":215},"2027-07-30",{"name":5,"class":6},4]