[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100531577":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":29,"centralContacts":29,"locations":34,"responsibleParty":89,"collaborators":29,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":93,"sex":99,"minAge":29,"maxAge":100,"enrollmentInfo":101,"targetDuration":29,"studyType":104,"phases":105,"briefSummary":108,"conditions":109,"keywords":29,"overallStatus":37,"whyStopped":29,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"St. John's Research Institute","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Nebivolol+ Standard care arm","EXPERIMENTAL","This arm will receive tablet Nebivolol 2.5 mg OD uptitrated at 2 weeks to 5 mg and at 4 weeks if well tolerated to 10 mg\u002Fday which the participant will continue upto week 24",[13],"Drug: Nebivolol+ Standard care arm",{"label":15,"type":16,"description":17,"interventionNames":18},"Epalrestat + Alpha Lipoic Acid +Standard care","ACTIVE_COMPARATOR","This arm will receive tablet Epalrestat -150mg OD+ cap Alpha Lipoic Acid 600mg OD for 24 weeks.",[19],"Drug: Epalrestat + Alpha Lipoic Acid +Standard care",{"label":21,"type":16,"description":22,"interventionNames":23},"Standard care alone","Patients in this arm will receive standard care as judged by their treating physicians which is generally pain modifying treatment.",[24],"Drug: Standard care alone",[26,30,32],{"type":27,"name":9,"description":11,"armGroupLabels":28,"otherNames":29},"DRUG",[9],null,{"type":27,"name":15,"description":17,"armGroupLabels":31,"otherNames":29},[15],{"type":27,"name":21,"description":22,"armGroupLabels":33,"otherNames":29},[21],[35,58],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"St John's Medical College Hospital","RECRUITING","Bangalore","Karnataka","560034","India","IN",{"type":44,"coordinates":45},"Point",[46,47],77.59369,12.97194,{"lat":47,"lon":46},[50,55],{"name":51,"role":52,"phone":53,"phoneExt":29,"email":54},"Deepak Kamath, MBBS, MD","CONTACT","9945519522","kamath.deepak@sjri.res.in",{"name":56,"role":57,"phone":29,"phoneExt":29,"email":29},"Belinda George, MD,DM","PRINCIPAL_INVESTIGATOR",{"facility":59,"status":60,"city":38,"state":61,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":62,"geoPoint":64,"contacts":65},"St John's Research Institute","NOT_YET_RECRUITING","Karntakaka",{"type":44,"coordinates":63},[46,47],{"lat":47,"lon":46},[66,68,72,74,77,79,81,83,85,87],{"name":67,"role":52,"phone":53,"phoneExt":29,"email":54},"Dr Deepak Y Kamath",{"name":69,"role":52,"phone":70,"phoneExt":29,"email":71},"Dr.Belinda George","9845123443","georgebelinda@gmail.com",{"name":73,"role":57,"phone":29,"phoneExt":29,"email":29},"Dr.Belinda George, MD DM",{"name":75,"role":76,"phone":29,"phoneExt":29,"email":29},"Dr Deepak Y Kamath, MD","SUB_INVESTIGATOR",{"name":78,"role":76,"phone":29,"phoneExt":29,"email":29},"Dr.GRK Sarma, MD DM",{"name":80,"role":76,"phone":29,"phoneExt":29,"email":29},"Dr Shifra S, MD",{"name":82,"role":76,"phone":29,"phoneExt":29,"email":29},"Dr Yamini VR Priya, MD",{"name":84,"role":76,"phone":29,"phoneExt":29,"email":29},"Dr Shruthi Kulkarni, MBBS DNB",{"name":86,"role":76,"phone":29,"phoneExt":29,"email":29},"Dr Maria F Bukelo, MD",{"name":88,"role":76,"phone":29,"phoneExt":29,"email":29},"Dr Madhukara J, MD",{"type":90,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100531577","phase-2-evaluating-a-nitric-oxide-generator-nebivolol-as-a-disease-modifier-in-patients-with-diabetic-neuropathy-100531577",false,"NCT06201611","Evaluating a Nitric Oxide Generator, Nebivolol as a Disease Modifier in Patients With Diabetic Neuropathy.","A 3-arm, Open-label, Stratified Randomized Controlled Trial With Blinded End-point Assessment to EValuate A Nitric oxidE Generator (Nebivolol) as a diSease Modifying mediCatioN in Diabetic Peripheral Neuropathy","EVANESCENT-DPN","Inclusion Criteria:\n\n1. Patients aged \\>= 18 years diagnosed with diabetes mellitus, of a duration of \\\u003C= 5 years since their diagnosis\n2. HbA1c \\\u003C 9 at enrolment with stable glycemic control for the last three months\n3. Neuropathy meeting the following 'Toronto criteria' (8) - (a) abnormal nerve conduction study\\* based on age-matched controls at the site and - (b) a symptom or sign of neuropathy defined as one of either a diabetic neuropathy symptom score of \\>= 1\u002F4 Or neuropathy disability score of \\>= 3\u002F10 (9).\n\n   * Abnormal NCS defined as one or more abnormal Z score in two or more nerves, based on sural nerve amplitude (antidromic stimulation), tibial and peroneal NCV, tibial amplitude, increased F-wave minimum latency (F-min), and absent F-waves (only considered abnormal in tibial nerve)\n\nExclusion Criteria:\n\n1. Absolute contra-indications for nebivolol - sick-sinus syndrome, sinus bradycardia with a resting heart rate \\\u003C 50\u002F minute, second or third degree AV-nodal blocks fascicular blocks, severe asthma or COPD and acute heart failure\n2. Patients with a compelling indication for a non-dihydropyridine calcium channel blocker (CCB)\n3. Patients with compelling need for another beta-blocker in the judgement of the treating team\n\nPatients who have undergone major amputations of the lower limbs or are posted for the same.","ALL","18 Years",{"count":102,"type":103},120,"ESTIMATED","INTERVENTIONAL",[106,107],"PHASE2","PHASE3","The goal of this clinical trial is to test in patients with diabetic neuropathy,\n\n* Can Nevibolol at a dose of 2.5 mg- 10 mg compared with standard pain modulating treatment conserve the mean nerve action potential amplitude (sural and tibial nerves) at 24 weeks follow- up.\n* Can Nevibolol at a dose of 2.5 mg- 10 mg compared with a combination of Alpha Lipoic Acid (600 mg\u002Fday)+EPALRESTAT (150 mg\u002Fday) conserve the mean nerve action potential amplitude (sural and tibial nerves) at 24 weeks follow- up\n\n  * All potential participants will undergo screening- about 10 ml of blood will be drawn to perform the following assesments at screening- HbA1c, FBS,Vit B12, TSH, fT4.\n  * Baseline assessments conducting a nerve conduction study, quality of life assesment using Eq-5D-5L and NRS pain score.\n  * 20% of patients (24 patients) will undergo Sudoscan, Corneal confocal microscopy and a skin biopsy for assessing IENFD (Intra Epidermal Nerve Fibre Density).\n  * 15th day, 1 month and 3rd month followup for evaluating patients status and medication adherance.\n  * 6th month followup for evaluating patients status and medication adherance.\n\nResearchers will compare Nebivolol against combination of Epalrestat+Alpha Lipoic Acid against standard pain modulating treatment to evaluate their diseaes modifying effect as reflected by nerve conduction study parameters.",[110],"Diabetic Neuropathy Peripheral","2025-02-01",{"date":113,"type":114},"2025-02-04","ACTUAL",{"date":116,"type":114},"2024-11-15",{"date":118,"type":103},"2026-03-30",{"name":5,"class":6},2]