[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100400168":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":36,"studyPopulation":26,"armGroups":37,"interventions":49,"overallOfficials":55,"centralContacts":60,"locations":66,"responsibleParty":83,"collaborators":26,"id":85,"slug":26,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":88,"acronym":26,"eligibilityCriteria":89,"healthyVolunteers":90,"sex":91,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":26,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":26,"overallStatus":68,"whyStopped":26,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"TCI Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"Change from baseline in blood pressure (systolic blood pressure, diastolic blood pressure)","Blood pressure will be measured at the beginning, 4-week, and 8-week time points.","Days 1, 28, and 56",[14,17,20,23],{"measure":15,"description":16,"timeFrame":12},"Change from baseline in Body Mass Index (BMI)","Body Mass Index (kg\u002Fm\\^2) will be measured at the beginning, 4-week, and 8-week time points.\n\nP.S. weight in kilograms, height in meters",{"measure":18,"description":19,"timeFrame":12},"Change from baseline in waist-hip ratio","Waist-hip ratio will be measured at the beginning, 4-week, and 8-week time points.",{"measure":21,"description":22,"timeFrame":12},"Change from baseline in blood lipid (total-Cholesterol, triglyceride, HDL-C, LDL-C)","Blood lipid will be measured at the beginning, 4-week, and 8-week time points.",{"measure":24,"description":25,"timeFrame":12},"Change from baseline in blood cardiovascular disease risk biomarker (hs-CRP, NO, Trimethylamine-N-oxide)","Blood cardiovascular disease risk biomarker will be measured at the beginning, 4-week, and 8-week time points.",null,{"allocation":28,"interventionModel":29,"interventionModelDescription":26,"primaryPurpose":30,"observationalModel":26,"timePerspective":26,"maskingInfo":31},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":32,"maskingDescription":26,"whoMasked":33},"DOUBLE",[34,35],"PARTICIPANT","INVESTIGATOR","This is a double-blind and randomized study. Subjects are informed to consume the samples every day for 2 months. The clinical diagnosis item of cardiovascular disease is evaluated by the doctor.",[38,44],{"label":39,"type":40,"description":41,"interventionNames":42},"Placebo","PLACEBO_COMPARATOR","consume 1 sachet per day for 2 months",[43],"Dietary Supplement: Placebo",{"label":45,"type":46,"description":41,"interventionNames":47},"Buckwheat husk extract","EXPERIMENTAL",[48],"Dietary Supplement: Buckwheat husk extract",[50,53],{"type":51,"name":39,"description":41,"armGroupLabels":52,"otherNames":26},"DIETARY_SUPPLEMENT",[39],{"type":51,"name":45,"description":41,"armGroupLabels":54,"otherNames":26},[45],[56],{"name":57,"affiliation":58,"role":59},"Mao-Hsin Lin, Doctor","National Taiwan University Hospital","PRINCIPAL_INVESTIGATOR",[61],{"name":62,"role":63,"phone":64,"phoneExt":26,"email":65},"Shyr-Chyr Chen","CONTACT","(02) 23123456","scchen@ntu.edu.tw",[67],{"facility":58,"status":68,"city":69,"state":26,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"RECRUITING","Taipei","114","Taiwan","TW",{"type":74,"coordinates":75},"Point",[76,77],121.52639,25.05306,{"lat":77,"lon":76},[80],{"name":81,"role":63,"phone":26,"phoneExt":26,"email":82},"chi fu chiang, Ph.D","Jimmy.Chiang@tci-bio.com",{"type":84,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100400168",false,"NCT04490720","The Efficacy Evaluation of Buckwheat Husk Extract on Cardiovascular Disease Risk Factors","Inclusion Criteria:\n\n1. 20 to 65-year-old males or non-pregnant females who are willing to sign the subject's consent.\n2. The systolic blood pressure is 121-139 mmHg and the diastolic blood pressure is between 81-89 mmHg.\n3. Those who are not pregnant and are willing to cooperate with contraception during the trial period.\n4. No history of organ transplantation, epilepsy or convulsions, liver or kidney disease, malignant tumor, endocrine disease, mental disease, alcohol or drug abuse, or other major organic diseases (according to medical history).\n\nExclusion Criteria:\n\n1. Pregnant women.\n2. People with a history of organ transplantation, epilepsy or convulsions, liver and kidney disease, malignant tumors, endocrine diseases, mental illness, alcohol or drug abuse, and other major organic diseases (according to medical history).\n3. No person has undergone major surgery.",true,"ALL","20 Years","65 Years",{"count":95,"type":96},60,"ESTIMATED","INTERVENTIONAL",[99],"NA","To assess the efficacy evaluation of buckwheat husk extract on cardiovascular disease risk factors",[102],"Cardiovascular Diseases","2025-01-08",{"date":105,"type":106},"2025-01-09","ACTUAL",{"date":108,"type":106},"2021-11-24",{"date":110,"type":96},"2026-02-28",{"name":5,"class":6},1]