[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604606":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":42,"locations":49,"responsibleParty":66,"collaborators":27,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":72,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":27,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":92,"overallStatus":96,"whyStopped":27,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Taipei Veterans General Hospital, Taiwan","OTHER_GOV",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Intranasal PRP injection","EXPERIMENTAL","Participants in this arm will receive an intranasal injection of autologous platelet-rich plasma (PRP) into the olfactory cleft. The procedure will be conducted under local anesthesia using endoscopic guidance. All participants will also perform standardized daily olfactory training for three months following the intervention.",[13,14,15],"Procedure: Intranasal Injection of Autologous PRP","Combination Product: platelet-rich plasma","Device: olfactory training",{"label":17,"type":10,"description":18,"interventionNames":19},"Topical PRP application arm","Participants in this arm will receive a topical application of autologous PRP delivered via PRP-soaked absorbable material (Gelfoam) placed into the olfactory cleft. No needle will be used. The placement will be guided by nasal endoscopy under local anesthesia. Daily olfactory training will be continued for three months post-application.",[20,14,15],"Procedure: Carrier-Assisted Topical Application of Autologous PRP",[22,28,32,37],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"PROCEDURE","Intranasal Injection of Autologous PRP","Under topical anesthesia and decongestion, approximately 1 mL of freshly prepared autologous platelet-rich plasma will be injected into multiple sites of the olfactory cleft mucosa bilaterally using a 25-gauge needle under endoscopic guidance. Single treatment session.",[9],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Carrier-Assisted Topical Application of Autologous PRP","Four pieces of sterile, bioabsorbable carrier (Gelfoam sponge) will be soaked with approximately 5 mL of freshly prepared autologous platelet-rich plasma. Under endoscopic guidance, two pieces will be placed gently into each olfactory cleft, ensuring contact with the olfactory mucosa. Carriers will remain briefly to allow PRP diffusion before dissolving naturally or being removed. Single treatment session.",[17],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":27},"COMBINATION_PRODUCT","platelet-rich plasma","This study adopts a fully automated, closed-system PRP preparation technique to ensure the stability of the blood product. A total of 60 mL of whole blood is drawn and processed using the Phoenix Q1 centrifuge (TFDA Medical Device Manufacturing License No. 004461) for blood component separation in a closed, sterile environment. An optical sensor identifies and automatically collects the buffy coat layer (rich in platelets and monocytes), yielding approximately 6 mL of autologous platelet-rich plasma (PRP). The centrifugation and PRP collection process takes about 5 minutes. Compared with traditional methods requiring manual identification and collection, this approach enhances the precision and safety of centrifugation-based preparation.",[9,17],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":27},"DEVICE","olfactory training","Participants will perform olfactory training for 12 weeks following the PRP intervention. Training is conducted twice daily using four odor bottles containing standardized odorants from Sigma-Aldrich (Germany): lemon (citronellal, #27470), rose (phenylethanol, #77861), clove (eugenol, #W246700), and eucalyptus (eucalyptol, #C80601). Each odor is sniffed gently for about 20 seconds, with a 20-second pause between bottles. Participants will record the perceived intensity of each odor in a training diary after every session.",[9,17],[43],{"name":44,"role":45,"phone":46,"phoneExt":47,"email":48},"Dr. Yun-Ting Chao Principal Investigator (Attending Physician and Head of Dep.), PhD","CONTACT","886-2-2875-7337","122","yunting001@gmail.com",[50],{"facility":51,"status":27,"city":52,"state":27,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Taipei Veterans General Hospital","Taipei","112201","Taiwan","TW",{"type":57,"coordinates":58},"Point",[59,60],121.52639,25.05306,{"lat":60,"lon":59},[63],{"name":64,"role":45,"phone":65,"phoneExt":27,"email":48},"Yun-Ting Chao, MD, PhD","+886228757808",{"type":67,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"PRINCIPAL_INVESTIGATOR","Yun-Ting Chao","Dr.","100604606","phase-3-topical-versus-injection-prp-for-olfactory-dysfunction-100604606",false,"NCT07151703","Topical Versus Injection PRP for Olfactory Dysfunction","Carrier-Assisted Topical Application Versus Intranasal Injection of Autologous Platelet-Rich Plasma for Olfactory Dysfunction: A Randomized Controlled Trial","TOP-IN","Inclusion Criteria:\n\n* Aged between 18 and 80 years, regardless of sex\n* Subjective complaint of olfactory dysfunction with confirmed hyposmia or anosmia based on standardized olfactory testing\n* History of at least 3 months of prior olfactory training but with persistent olfactory complaints\n\nExclusion Criteria:\n\n* Congenital anosmia\n* Diagnosed neurological or structural brain abnormalities (e.g., brain tumor, major head trauma, stroke) with low likelihood of olfactory recovery\n* Inability or unwillingness to comply with study procedures or follow-up assessments","ALL","18 Years","80 Years",{"count":82,"type":83},60,"ESTIMATED","INTERVENTIONAL",[86],"PHASE3","The goal of this clinical trial is to determine whether two different delivery methods of autologous platelet-rich plasma (PRP) can improve olfactory function in adults with persistent olfactory dysfunction lasting more than three months. The main questions it aims to answer are:\n\n1. Does carrier-assisted topical application of PRP lead to comparable or better improvement in smell function than intranasal injection of PRP?\n2. Which method provides greater patient comfort and fewer adverse effects?\n\nResearchers will compare carrier-assisted topical PRP application to intranasal PRP injection to see if one approach is more effective in restoring olfactory function.\n\nParticipants will:\n\n1. Receive a single PRP treatment delivered either by injection or via a PRP-soaked carrier placed into the olfactory cleft.\n2. Continue daily olfactory training for three months following the intervention.\n3. Undergo smell testing (Sniffin' Sticks) before and after treatment and complete quality-of-life questionnaires.",[89,90,91],"Olfactory Dysfunction","Anosmia","Hyposmia",[90,91,93,94,95],"Platelet-Rich Plasma (PRP)","Intranasal Injection","Randomized Controlled Trial","NOT_YET_RECRUITING","2025-08-25",{"date":99,"type":100},"2025-09-03","ACTUAL",{"date":102,"type":83},"2025-10-01",{"date":104,"type":83},"2028-12-31",{"name":5,"class":6},1]