[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655098":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":34,"studyPopulation":34,"armGroups":43,"interventions":54,"overallOfficials":34,"centralContacts":60,"locations":34,"responsibleParty":70,"collaborators":34,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":74,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":34,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":97,"whyStopped":34,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":34},{"fullName":5,"class":6},"Jinnah Medical & Dental College","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":20,"otherOutcomes":34},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"MDS-UPDRS","Change in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score from baseline to 12 weeks to assess changes in Parkinson disease symptoms.\n\nThe MDS-UPDRS (Movement Disorder Society-Unified Parkinson's Disease Rating Scale) is the standard scale used to assess the severity and progression of Parkinson's disease (PD) and response to treatment.\n\nIt has 4 parts. Part I Non-motor experiences of daily living 52 Part II Motor experiences of daily living 52 Part III Motor examination performed by clinician 132 Part IV Motor complications of treatment, e.g., dyskinesia and fluctuations 24 Total score: 260\n\nEach item is generally scored:\n\n0 = Normal \u002F no problem\n\n1. = Slight\n2. = Mild\n3. = Moderate\n4. = Severe Higher scores represents greater severity of Parkinson's disease.","12weeks",{"measure":14,"description":15,"timeFrame":16},"MDA levels","Change in malondialdehyde (MDA) levels from baseline to 12 weeks to asses changes in oxidative stress","12 weeks",{"measure":18,"description":19,"timeFrame":16},"Alpha Synuclein levels","Change in serum alpha-synuclein concentration from baseline to 12 weeks",[21,25,29,32],{"measure":22,"description":23,"timeFrame":24},"Safety profile of metformin","Safety profile of the interventional drug (metformin) will be assed in Group B (intervention group) 30 patients.\n\nblood samples will be taken for blood (CBC) to check hemoglobin levels","From baseline to Week 12",{"measure":26,"description":27,"timeFrame":28},"Safety Profile of Metformin","Safety profile of the interventional drug (metformin) will be assed in Group B (intervention group) 30 patients. blood samples will be taken to assess the Renal side effects of drug by measuring Urea, creatinine, GFR","From baseline to week 12",{"measure":26,"description":30,"timeFrame":31},"Safety profile of the interventional drug (metformin) will be assed in Group B (intervention group) 30 patients. blood samples will be taken to assess the hepatic side effects of drug by measuring ALT,AST","Baseline to weeks 12",{"measure":26,"description":33,"timeFrame":28},"Safety profile of the interventional drug (metformin) will be assed in Group B (intervention group) 30 patients. blood samples will be taken to assess the Cardiac side effects of drug by measuring TGs, HDL",null,{"allocation":36,"interventionModel":37,"interventionModelDescription":38,"primaryPurpose":39,"observationalModel":34,"timePerspective":34,"maskingInfo":40},"RANDOMIZED","PARALLEL","Model Description","SUPPORTIVE_CARE",{"masking":41,"maskingDescription":42,"whoMasked":34},"NONE","Masking Description",[44,48],{"label":45,"type":46,"description":47,"interventionNames":34},"Group A (satndard treatment group) control group","NO_INTERVENTION","patients will continue standard therapy with carbidopa levodopa 250\u002F25 mg TDS",{"label":49,"type":50,"description":51,"interventionNames":52},"Group B (Metformin group)","ACTIVE_COMPARATOR","patients will receive 500mg Metformin BD for 12 weeks along with standard treatment with carbidopa levodopa 250\u002F25mg TDS",[53],"Drug: Metformin 500mg",[55],{"type":56,"name":57,"description":58,"armGroupLabels":59,"otherNames":34},"DRUG","Metformin 500mg","Metformin will be given to the group B along with the standard treatment",[49],[61,66],{"name":62,"role":63,"phone":64,"phoneExt":34,"email":65},"Syeda Midhat Zaidi, MBBS","CONTACT","+923342434378","drmidhatzehra@gmail.com",{"name":67,"role":63,"phone":68,"phoneExt":34,"email":69},"Nasim Karim, MBBS, MPhil, PhD, Post-doc","+923323151774","nsm_karim@yahoo.com",{"type":71,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100655098","phase-4-metformin-in-parkinsons-disease-safety-and-efficacy-100655098",false,"NCT07806019","Metformin in Parkinson's Disease: Safety and Efficacy","Clinical Efficacy and Safety Profile of Metformin in Parkinson's Disease","MET-PD","Inclusion Criteria: :\n\nMale and female patients diagnosed with primary PD age 50-70 years receiving levodopa + carbidopa. Diagnosis will be made in accordance with movement disorder society clinical diagnostic criteria for Parkinson's disease\n\nExclusion Criteria:\n\nSecondary Parkinsonism co-morbid (such as Diabetes mellitus, Cardio-vascular diseases, Senile tremors, Wilson's disease, Cancers etc.) Pregnant and lactating mothers Sensitivity to metformin Lactic acidosis History of alcohol use","ALL","50 Years","70 Years",{"count":84,"type":85},70,"ESTIMATED","INTERVENTIONAL",[88],"PHASE4","This study will evaluate whether metformin when it will be given to patients with Parkinson's disease along with standard therapy (levodopa carbidopa) will improve motor symptoms and decreases levels of alpha synuclein and MDA in patients with PD as compare to PD patients receiving only standard therapy (levodopa carbidopa)",[91],"Parkinsons Disease (PD)",[93,94,95,96,14,10],"Parkinson's disease","Neuroinflamation","Metformin","Alpha synuclein","NOT_YET_RECRUITING","2026-09-07",{"date":100,"type":101},"2026-09-09","ACTUAL",{"date":103,"type":85},"2026-08-28",{"date":105,"type":85},"2027-02-01",{"name":5,"class":6}]