[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100552450":3},{"organization":4,"armGroups":7,"interventions":31,"overallOfficials":35,"centralContacts":44,"locations":54,"responsibleParty":135,"collaborators":35,"id":137,"slug":138,"hasResults":139,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":35,"eligibilityCriteria":143,"healthyVolunteers":144,"sex":145,"minAge":146,"maxAge":147,"enrollmentInfo":148,"targetDuration":35,"studyType":151,"phases":152,"briefSummary":154,"conditions":155,"keywords":35,"overallStatus":57,"whyStopped":35,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":166},{"fullName":5,"class":6},"Vedic Lifesciences Pvt. Ltd.","INDUSTRY",[8,14,18,22,26],{"label":9,"type":10,"description":11,"interventionNames":12},"CBD Isolate (25 mg\u002F0.5 ml)","ACTIVE_COMPARATOR","0.5 ml sublingually to be consumed after dinner, 30 min ± 5 mins before going to bed.",[13],"Dietary Supplement: CBD Isolate (25 mg\u002F0.5 ml)",{"label":15,"type":10,"description":11,"interventionNames":16},"CBD Isolate (40 mg\u002F0.5 ml)",[17],"Dietary Supplement: CBD Isolate (40 mg\u002F0.5 ml)",{"label":19,"type":10,"description":11,"interventionNames":20},"CBD Isolate (50 mg\u002F0.5 ml)",[21],"Dietary Supplement: CBD Isolate (50 mg\u002F0.5 ml)",{"label":23,"type":10,"description":11,"interventionNames":24},"CBD Broad Extract (50 mg\u002F0.5 ml)",[25],"Dietary Supplement: CBD Broad Extract (50 mg\u002F0.5 ml)",{"label":27,"type":28,"description":11,"interventionNames":29},"Placebo","PLACEBO_COMPARATOR",[30],"Dietary Supplement: Placebo",[32,36,38,40,42],{"type":33,"name":9,"description":11,"armGroupLabels":34,"otherNames":35},"DIETARY_SUPPLEMENT",[9],null,{"type":33,"name":15,"description":11,"armGroupLabels":37,"otherNames":35},[15],{"type":33,"name":19,"description":11,"armGroupLabels":39,"otherNames":35},[19],{"type":33,"name":23,"description":11,"armGroupLabels":41,"otherNames":35},[23],{"type":33,"name":27,"description":11,"armGroupLabels":43,"otherNames":35},[27],[45,50],{"name":46,"role":47,"phone":48,"phoneExt":35,"email":49},"Dr Sanjay Vaze, MBBS","CONTACT","8655670964","sanjay.v@vediclifesciences.com",{"name":51,"role":47,"phone":52,"phoneExt":35,"email":53},"Dr. Lalit Pawaskar, M.Pharm, PhD","7738418890","lalit.p@vediclifesciences.com",[55,74,88,99,110,121],{"facility":56,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Shivam Hospital","RECRUITING","Dombivali","Maharashtra","421203","India","IN",{"type":64,"coordinates":65},"Point",[66,67],73.08333,19.21667,{"lat":67,"lon":66},[70],{"name":71,"role":47,"phone":72,"phoneExt":35,"email":73},"Dr. Kushal Bangar, MBBS, MD (Medicine)","9545664884","drkushal.bangar83@gmail.com",{"facility":75,"status":57,"city":76,"state":59,"zip":77,"country":61,"countryCode":62,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Dhanwantri Hospital","Pune","411011",{"type":64,"coordinates":79},[80,81],73.85535,18.51957,{"lat":81,"lon":80},[84],{"name":85,"role":47,"phone":86,"phoneExt":35,"email":87},"Dr. Bharat Jain, MBBS, DNB","9860383386","dr_bharatjain@rediffmail.com",{"facility":89,"status":57,"city":76,"state":59,"zip":90,"country":61,"countryCode":62,"cosmosGeoPoint":91,"geoPoint":93,"contacts":94},"Vedant Multispeciality Hospital","411019",{"type":64,"coordinates":92},[80,81],{"lat":81,"lon":80},[95],{"name":96,"role":47,"phone":97,"phoneExt":35,"email":98},"Dr. Abhishek Karmalkar, MBBS, MD (Medicine)","9970004295","drkarmalkar.vedant@gmail.com",{"facility":100,"status":57,"city":76,"state":59,"zip":101,"country":61,"countryCode":62,"cosmosGeoPoint":102,"geoPoint":104,"contacts":105},"Punawale Hospital","411033",{"type":64,"coordinates":103},[80,81],{"lat":81,"lon":80},[106],{"name":107,"role":47,"phone":108,"phoneExt":35,"email":109},"Dr. Rajkumar Nikalje, MBBS, MD (Medicine)","9028560535","rajkumar.nikalje23@gmail.com",{"facility":111,"status":57,"city":76,"state":59,"zip":112,"country":61,"countryCode":62,"cosmosGeoPoint":113,"geoPoint":115,"contacts":116},"Vishwaraj Hospital","412201",{"type":64,"coordinates":114},[80,81],{"lat":81,"lon":80},[117],{"name":118,"role":47,"phone":119,"phoneExt":35,"email":120},"Dr Namdev Jagtap, MBBS, MD","9823914414","drjagtapdev@gmail.com",{"facility":122,"status":57,"city":123,"state":59,"zip":124,"country":61,"countryCode":62,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"Shree Ashirwad Hospital","Thane","421201",{"type":64,"coordinates":126},[127,128],72.96355,19.19704,{"lat":128,"lon":127},[131],{"name":132,"role":47,"phone":133,"phoneExt":35,"email":134},"Dr. Deepak Varade, MBBS, DNB","9870409142","deepak.varade@gmail.com",{"type":136,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100552450","a-study-to-determine-safety-pharmakokinetics-and-efficacy-of-the-different-doses-of-vl-se-01-in-healthy-participants-100552450",false,"NCT06473246","A Study to Determine Safety, Pharmakokinetics and Efficacy of the Different Doses of VL-SE-01 in Healthy Participants.","A Randomized, Double-blind, Placebo Controlled, Parallel Study to Determine Safety, Pharmakokinetics and Efficacy of the Different Doses of VL-SE-01 in Healthy Participants.","Inclusion Criteria:\n\n* Male \\& female individuals must be 18 to 55 years of age inclusive, at the time of signing the informed consent.\n* Individuals who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.\n* Individual has a body weight of at least 50 kg (males) or 45 kg (females) and body mass index (BMI) within the range 18.5 to 29.9 kg\u002Fm2 (inclusive)\n* Individuals with a stressed lifestyle as assessed by PSS scores within 27- 40.\n* A male must agree to use contraception during the intervention period and for at least 7 days after the last dose of study intervention and refrain from donating sperm during this period.\n* A female is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:\n\n  1. Not a woman of childbearing potential (WOCBP)\n  2. OR agrees to use the contraceptive during the intervention period and for at least 90 days after the last dose of study intervention\n\nExclusion Criteria:\n\n* Individual has a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinology related, haematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention, or interfering with the interpretation of data.\n* Males who has a history of oligospermia, vasectomy and other sperm abnormalities.\n* Females who have irregularity or problems in menstrual cycles or diagnosed with polycystic ovarian syndrome.\n* Individuals with Type 1 and Type 2 Diabetes mellitus and on medication.\n* Individuals with SBP ≥ 160 mmHg and DBP ≥ 100 mmHg.\n* Individuals on anti-hypertensives.\n* History and\u002For current cases of chronic alcohol consumption or heavy drinkers as defined by:\n\n  1. For men, consuming more than 4 drinks on any day or more than 14 drinks\u002Fweek\n  2. For women, consuming more than 3 drinks on any day or more than 7 drinks\u002Fweek\n* Peri and post-menopausal women with no menstrual cycle in the last 6 months\n* Individuals with a history or actively under the influence of Hemp or CBD products by any means of administration\n* Individual has a known hypersensitivity to any components of the study medication or comparative drugs (and\u002For an investigational device) as stated in this protocol\n* Individual has a history of unexplained syncope or a family history of sudden death due to long QT syndrome\n* Individual with a history and\u002For currently diagnosed of cancer like lymphoma, leukaemia, or any malignancy.\n* Individual has past or intended use of prohibited medication or prescription medication including herbal medications within 2 weeks or 5 half-lives prior to dosing\n* Individuals have taken sleep medication within 2 weeks prior to screening\n* Individual has used hepatic enzyme-inducing drugs within 2 months prior to dosing\n* Individuals has alanine transaminase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) \\>1.5 times upper limit of normal (ULN)\n* Individual has current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)\n* Individual has any clinically relevant electrocardiogram (ECG) finding at the Screening Visit or at Baseline\n* Individual has a history of human immunodeficiency virus (HIV), hepatitis B, and hepatitis C.",true,"ALL","18 Years","55 Years",{"count":149,"type":150},200,"ESTIMATED","INTERVENTIONAL",[153],"NA","The present study is a randomized, placebo-controlled, parallel study. 250 participants will be screened, and considering a screening failure rate of 20%, approximately 200 participants will be randomized in a ratio of 1:1:1:1:1 to receive either different doses of VL-SE-01 or placebo and will be assigned a unique randomization code. Each group will have at least 30 participants (total 150 completers) after accounting for a dropout\u002Fwithdrawal rate of 25%. The intervention duration for all the study participants is 180 days.",[156],"Healthy Population","2025-12-22",{"date":159,"type":160},"2025-12-30","ACTUAL",{"date":162,"type":160},"2025-02-20",{"date":164,"type":150},"2026-02-05",{"name":5,"class":6},6]