[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559749":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":42,"locations":50,"responsibleParty":74,"collaborators":77,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":18,"eligibilityCriteria":87,"healthyVolunteers":83,"sex":88,"minAge":89,"maxAge":18,"enrollmentInfo":90,"targetDuration":18,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":18,"overallStatus":53,"whyStopped":18,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Universiti Sains Malaysia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Bionerve","EXPERIMENTAL","The participants will receive a fixed dose combination of alpha lipoic acid and vitamin B preparations.",[13],"Drug: Alpha-Lipoic Acid\u002FVitamin\u002FMineral Supplement PolyMVA",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","NO_INTERVENTION","The participants will receive a placebo (look-alike substance that contains no drug)l",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Alpha-Lipoic Acid\u002FVitamin\u002FMineral Supplement PolyMVA","BIONERV® s the first combination of alpha lipoic acid 300mg and vitamin B complex. Bionerv® is in oral film-coated, orange colour, oblong shape and no marking and embossing on the tablet. Each tablet contains 4 active ingredients as follows: Alpha lipoic acid 300mg, Vitamin B12 (methylcobalamin) 500mcg, Vitamin B6 (pyridoxine) 8mg, Vitamin B1 (thiamine) 39mg. To be taken after meal 1 tablet once daily.",[9],[26],"BIONERV",[28,32,35,38,40],{"name":29,"affiliation":30,"role":31},"Che Nur Ain Che Abdullah, Dr.","Department of Family Medicine, School of Medical Sciences University Sains Malaysia, Health Campus","PRINCIPAL_INVESTIGATOR",{"name":33,"affiliation":30,"role":34},"Noraini Mohamad, Dr.","STUDY_DIRECTOR",{"name":36,"affiliation":30,"role":37},"Nani Draman, Prof. Dr.","STUDY_CHAIR",{"name":39,"affiliation":30,"role":37},"Ritzzaleena Rosli Mohd Rosli, Dr.",{"name":41,"affiliation":30,"role":37},"Zainab Mat Yudin@Badrin, Dr.",[43,47],{"name":29,"role":44,"phone":45,"phoneExt":18,"email":46},"CONTACT","+60199216023","chenurain@student.usm.my",{"name":33,"role":44,"phone":48,"phoneExt":18,"email":49},"+60139855968","mnoraini@usm.my",[51],{"facility":52,"status":53,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Hospital Universiti Sains Malaysia","RECRUITING","Kubang Kerian","Kelantan","16150","Malaysia","MY",{"type":60,"coordinates":61},"Point",[62,63],102.27938,6.09123,{"lat":63,"lon":62},[66,67,68,69,70,72,73],{"name":29,"role":44,"phone":45,"phoneExt":18,"email":46},{"name":33,"role":44,"phone":48,"phoneExt":18,"email":49},{"name":29,"role":31,"phone":18,"phoneExt":18,"email":18},{"name":33,"role":31,"phone":18,"phoneExt":18,"email":18},{"name":36,"role":71,"phone":18,"phoneExt":18,"email":18},"SUB_INVESTIGATOR",{"name":41,"role":71,"phone":18,"phoneExt":18,"email":18},{"name":39,"role":71,"phone":18,"phoneExt":18,"email":18},{"type":31,"investigatorFullName":75,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Che Nur Ain binti Che Abdullah","Principal Investigator",[78],{"name":79,"class":80},"BREGO Life Sciences Sdn Bhd","INDUSTRY","100559749","phase-2-the-effect-of-alpha-lipoid-acid-and-vitamin-b-preparation-on-diabetic-polyneuropathy-in-type-2-diabetes-mellitus-patient-100559749",false,"NCT06568185","The Effect of Alpha Lipoid Acid and Vitamin B Preparation on Diabetic Polyneuropathy in Type 2 Diabetes Mellitus Patient","The Effectiveness of Fixed Dose Combination of Alpha Lipoic Acid and Vitamin B Preparations for Treatment of Diabetic Polyneuropathy in Type 2 Diabetes Mellitus Patients: A Randomized Placebo-controlled Trial","Inclusion Criteria:\n\n1. Aged 18 years and over\n2. Diagnosed with type 2 diabetes mellitus based on WHO diagnostic criteria for diabetes (Organization, 2020).\n3. Diagnose with diabetic polyneuropathy by Neurological Symptom Score (NSS) and Neuropathy Disability Score (NDS).\n\nExclusion Criteria:\n\n1. Those with a documented mental impairment which impacted on their ability to answer questions independently.\n2. People with peripheral vascular disease (non-palpable foot pulses, intermittent claudication)\n3. People with an amputated foot or leg\n4. Abnormal liver enzyme.\n5. People with renal impairment.\n6. People using drugs with possible influence on the study results (antidepressants, anticonvulsants, opiates, neuroleptics, antioxidants, and particularly methylcobalamin, pyridoxine and other B complex preparations)\n7. Pregnancy, lactation, or childbearing age without safe contraception\n8. History of allergy with vitamin B complex preparations (i.e. Vitamin B12, B6 and B1) and alpha lipoic acid.","ALL","18 Years",{"count":91,"type":92},76,"ESTIMATED","INTERVENTIONAL",[95],"PHASE2","To evaluate the efficacy of combination of vitamin B and alpha lipoic acid formulations for the treatment of diabetic polyneuropathy in individuals with type 2 diabetes mellitus.\n\nMethodology :\n\nThis is a single-center, randomized, double-blind, placebo-controlled trial study.\n\nStudy duration May 2024 - September 2025\n\nStudy location :\n\nThis study will be conducted at the Klinik Rawatan Keluarga and diabetes clinic Hospital Universiti Sains Malaysia.\n\nSource Reference :\n\nPeople with type 2 diabetes mellitus attending the Hospital Universiti Sains Malaysia.\n\nStudy source population :\n\nPeople with type 2 diabetes mellitus attended Klinik Rawatan Keluarga and diabetes clinic Hospital Universiti Sains Malaysia during the study period.",[98],"Diabetic Polyneuropathy","2024-08-20",{"date":101,"type":102},"2024-08-23","ACTUAL",{"date":104,"type":102},"2024-05-27",{"date":106,"type":92},"2025-09-01",{"name":5,"class":6},1]