[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643992":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":50,"collaborators":26,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":54,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":26,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":73,"overallStatus":79,"whyStopped":26,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Nimsai Academia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Nimsai Herbal Group","EXPERIMENTAL","Participants in this arm will receive Nimsai Herbal capsules (600 mg) orally once daily for 10 consecutive days. Nimsai Herbal is a proprietary oral phytotherapeutic formulation. The product is approved as a food supplement by the Turkish Ministry of Agriculture and Forestry (TEG Approval No: 015473-13.12.2022).",[13],"Dietary Supplement: Nimsai Herbal",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo Group","PLACEBO_COMPARATOR","Participants in this arm will receive placebo capsules identical in appearance, taste, and packaging to Nimsai Herbal, administered orally once daily for 10 consecutive days.",[19],"Other: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Nimsai Herbal","600 mg oral capsule taken once daily. Contains a proprietary blend of Centella asiatica extract, Curcuma longa extract, and Piper nigrum extract.",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo","Identical-appearing oral capsule containing inert ingredients, matched for taste and packaging.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Cem Atabiner","CONTACT","05324593292","info@nimsai.com",[38],{"facility":39,"status":26,"city":40,"state":26,"zip":26,"country":41,"countryCode":26,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Nimsai Academia Clinical Research Center","Bursa","Turkey (Türkiye)",{"type":43,"coordinates":44},"Point",[45,46],29.06013,40.19559,{"lat":46,"lon":45},[49],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},{"type":51,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100643992","phase-3-nimsai-herbal-for-grade-2-3-hemorrhoids-a-quadruple-blind-placebo-controlled-mechanistic-trial-100643992",false,"NCT07669662","Nimsai Herbal for Grade 2-3 Hemorrhoids: A Quadruple-Blind Placebo-Controlled Mechanistic Trial","Quadruple-Blind, Placebo-Controlled, Parallel-Group Randomized Controlled Trial to Evaluate the Efficacy and Safety of Nimsai Herbal in Patients With Grade 2-3 Hemorrhoids","NAJ2","Inclusion Criteria:\n\n* Endoscopically confirmed Grade 2 or 3 internal hemorrhoids\n\nHistory of hemorrhoidal symptoms persisting for more than 6 weeks prior to screening\n\nAge 18 to 70 years inclusive at time of informed consent\n\nWillingness and ability to provide written informed consent\n\nWillingness and ability to comply with all study procedures, schedules, and follow-up requirements\n\nExclusion Criteria:\n\n* Diagnosis of Grade 1 or Grade 4 hemorrhoids\n\nAny known anorectal malignancy or suspicion of malignancy\n\nActive bleeding from sources other than hemorrhoids\n\nCurrently pregnant or lactating women, or women of childbearing potential not using effective contraception\n\nKnown hypersensitivity or allergy to any component of Nimsai Herbal or placebo\n\nSignificant systemic diseases including severe cardiovascular disease, severe renal impairment, severe hepatic dysfunction, or uncontrolled diabetes mellitus (HbA1c \\> 9%)\n\nAny medical or psychiatric condition that might compromise participant safety or data integrity\n\nParticipation in another interventional clinical trial within 30 days prior to screening\n\nUse of concurrent treatments for hemorrhoids within 7 days prior to screening\n\nHistory of hemorrhoidectomy or other invasive hemorrhoid procedures within the last 6 months","ALL","18 Years","70 Years",{"count":64,"type":65},50,"ESTIMATED","INTERVENTIONAL",[68],"PHASE3","This randomized, quadruple-blind, placebo-controlled clinical trial evaluates the efficacy and safety of Nimsai Herbal, a proprietary oral phytotherapeutic formulation, in 50 participants aged 18-70 years with endoscopically confirmed Grade 2-3 internal hemorrhoids. Participants will be randomly assigned in a 1:1 ratio to receive either Nimsai Herbal (600 mg) or identical placebo once daily for 10 consecutive days. The primary endpoint is hemorrhoid regression at Day 10, defined as either a reduction in Goligher grade or a ≥75% reduction in composite hemorrhoid severity score. Secondary endpoints include change in symptom severity measured by Visual Analog Scale and complete symptom resolution rate. The study is designed as a mechanistic signal-detection investigation based on the War-Drill Model, which posits venous congestion as the primary initiating event in hemorrhoid pathogenesis.",[71,72],"Hemorrhoid","Hemorrhoidal Disease",[74,75,76,77,23,78],"venous stasis","War-Drill Model","Parola Phenomenon","phytotherapy","quadruple-blind","NOT_YET_RECRUITING","2026-06-20",{"date":82,"type":83},"2026-06-25","ACTUAL",{"date":85,"type":65},"2026-06-22",{"date":87,"type":65},"2026-07-02",{"name":5,"class":6},1]