[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649007":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":54,"collaborators":18,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":22,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":18,"enrollmentInfo":65,"targetDuration":18,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":39,"whyStopped":18,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"LifeBiotic Medical Research Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"LCS103 + Standard of Care","EXPERIMENTAL","Patients in the investigational arm will receive 1-year bidaily 3 oral tablets of LCS103 herbal formula, in addition to the SOC recommended per risk group",[13],"Dietary Supplement: LCS103",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of Care Alone","NO_INTERVENTION","Participants in the control arm will receive SOC-recommended treatment according to risk group",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DIETARY_SUPPLEMENT","LCS103","LCS103 is an oral botanical dietary supplement composed of multiple herbal extracts. Participants in the investigational arm will receive 3 tablets twice daily for 12 months in addition to the standard of care according to the EAU risk group.",[9],[26],{"name":27,"affiliation":28,"role":29},"Etan Eigner, MD","Rambam Health Care Campus","PRINCIPAL_INVESTIGATOR",[31],{"name":32,"role":33,"phone":34,"phoneExt":18,"email":35},"Yair Maimon, Dr.","CONTACT","+972-3-5043030","yair@tcm.org.il",[37],{"facility":38,"status":39,"city":40,"state":18,"zip":18,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Rambam Health Care Campus, Urology Department","RECRUITING","Haifa","Israel","IL",{"type":44,"coordinates":45},"Point",[46,47],34.99928,32.81303,{"lat":47,"lon":46},[50],{"name":51,"role":33,"phone":52,"phoneExt":18,"email":53},"Etan Eigner, Dr.","+972-4-7771799","E_EIGNER@rambam.health.gov.il",{"type":55,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100649007","lcs103-herbal-formula-for-secondary-prevention-of-non-muscle-invasive-urothelial-carcinoma-of-the-bladder-100649007",false,"NCT07728474","LCS103 Herbal Formula for Secondary Prevention of Non-Muscle Invasive Urothelial Carcinoma of the Bladder","LCS103 Herbal Formula for Secondary Prevention of Non-Muscle Invasive Urothelial Carcinoma of the Bladder - Phase IIA Randomized Controlled Trial","Inclusion Criteria:\n\n* Men and women aged ≥ 18 years.\n* Non-muscle invasive urothelial carcinoma, histologically confirmed by TURBT procedure within 3 months before enrollment.\n* Complete resection of bladder tumor in recent TURBT.\n\nExclusion Criteria:\n\n* Inability to provide informed consent.\n* Inability to swallow tablets (esophageal stricture, feeding through gastrostomy).\n* Ineligibility for SOC therapy such as BCG instillations (where appropriate).\n* Upper tract urothelial carcinoma within the past 2 years.\n* Any malignancy other than NMIBC, active or systemically treated within the past 2 years (not including localized cutaneous basal cell or squamous cell carcinoma).\n* Estimated life expectancy \\\u003C 5 years.\n* Pregnant women, and women planning future pregnancy or wishing to preserve fertility.\n* Investigator evaluation of a physical or mental condition limiting a patient's ability to participate in the study.","ALL","18 Years",{"count":66,"type":67},60,"ESTIMATED","INTERVENTIONAL",[70],"NA","This study is a phase IIA, single-site, randomized, controlled, open-label clinical trial evaluating the safety and efficacy of the LCS103 oral herbal formula for the secondary prevention of NMIBC. The study will include 60 participants randomized 1:1 to either the investigational or control arm.\n\nPatients in the investigational arm will receive three oral tablets of LCS103 herbal formula twice daily for 1 year, in addition to the SOC recommended per risk group:\n\n* Low Risk: Cystoscopic follow-up at 3 \\& 9 months and yearly thereafter.\n* Intermediate Risk: 1-year intravesical instillations of BCG. Cystoscopic follow-up at 3 \\& 9 months, then biannually for 2 years and yearly thereafter.\n* High Risk: 3-year intravesical instillations of BCG. Cystoscopy and urine cytology every 3 months for 2 years, then biannually thereafter.\n\nParticipants in the control arm will receive SOC treatment as mentioned above. After 1 year, the investigational treatment will be stopped, and all participants will continue SOC treatment and surveillance.\n\nThe enrollment period is expected to be 1 year. The study will be terminated after the final visit of the last patient. The total study duration is expected to be 2 years.",[73],"Non-muscle Invasive Bladder Cancer (NMIBC)",[75,76,77],"NMIBC","Bladder Cancer","Non-Muscle Invasive Bladder Cancer","2026-07-28",{"date":80,"type":81},"2026-07-29","ACTUAL",{"date":83,"type":67},"2026-07",{"date":85,"type":67},"2028-12",{"name":5,"class":6},1]