[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100552941":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":33,"locations":32,"responsibleParty":42,"collaborators":47,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":51,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":32,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":72,"whyStopped":32,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":32},{"fullName":5,"class":6},"Ain Shams University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Piracetam Group","ACTIVE_COMPARATOR","receiving standard care according to the institution's protocol, along with 800mg oral tablet of Piracetam three times every day for the whole duration of the study ( 3 Months) Standard care includes insulin therapy with or without oral hypoglycemics and vitamin b complex.",[13],"Drug: Piracetam",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group","PLACEBO_COMPARATOR","will receive standard care in accordance with the institution protocol in addition to placebo for 3 months.\n\nStandard care includes insulin therapy with or without oral hypoglycemics and vitamin b complex.",[19],"Drug: Placebo",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Piracetam","800mg oral tablet of Piracetam three times every day for 3 months",[9],[27],"no other interventions",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Placebo","starch tablet",[15],null,[34,39],{"name":35,"role":36,"phone":37,"phoneExt":32,"email":38},"Hamsa A. Attia","CONTACT","01225981809","hamsa.attia@ksiu.edu.eg",{"name":40,"role":36,"phone":41,"phoneExt":32,"email":32},"Amr Ali Mahfouz, Endocrinology consultant-PhD","01005786349",{"type":43,"investigatorFullName":44,"investigatorTitle":45,"investigatorAffiliation":46,"oldNameTitle":32,"oldOrganization":32},"PRINCIPAL_INVESTIGATOR","Hamsa Amr Mohamed Attia","Teaching Assistant at clinical pharmacy department","King Salman International university",[48],{"name":46,"class":6},"100552941","phase-4-the-effect-of-piracetam-on-diabetic-peripheral-neuropathy-patients-100552941",false,"NCT06479629","The Effect of Piracetam on Diabetic Peripheral Neuropathy Patients","The Effect of Piracetam on the Clinical Outcomes of Diabetic Patients with Peripheral Neuropathy","DPN","Inclusion Criteria:\n\n1. Adults (\\>the age of 18).\n2. Established diagnosis of type 2 Diabetes Mellitus.\n3. Patients receiving insulin therapy.\n4. Stable regimen for at least 3 months prior to inclusion in the study\n5. HbA1C\\>7.5%\n\nExclusion Criteria:\n\n* Patients with inadequate hepatic function Alanine aminotransferase, Aspartate aminotransferase (ALT, AST \\> or equal to 3 times upper normal limit).\n* Patients with myopathy, epilepsy, malignancy, unstable psychiatric illness, bleeding tendency, or peripheral vascular diseases.\n* Patients with an estimated Glomerular Filtration Rate (GFR) Less than 45 ml\u002Fmin and albumin\u002Fcreatinine ratio or urea to creatinine \\>30.\n* Patients with any conditions that could confound pain assessment (for ex: other severe pain or skin conditions in the area affected by neuropathy.\n* Cognitive or language difficulties that would impair understanding\u002Fcompletion of the assessment instruments.\n* Presence of foot ulcers.\n* Causes of neuropathy other than diabetes and significant neurological diseases.\n* Pregnant and\u002For breastfeeding women.\n* Use anticonvulsants, antidepressants, membrane stabilizers, and opioids.\n* Patients with a history of Substance use and alcohol abuse,\n* Patients with a history of (cerebral hemorrhage) or at risk of blood diseases.\n* Patients allergic to piracetam","ALL","18 Years","65 Years",{"count":61,"type":62},60,"ESTIMATED","INTERVENTIONAL",[65],"PHASE4","Aim of the work:\n\nTo evaluate efficacy and safety of Piracetam in Diabetic patients with peripheral neuropathy.\n\nScientific background:\n\nDiabetes mellitus (DM) is known to precipitate various neurologic complications, with diabetic neuropathy (DN) emerging as a significant microvascular consequence affecting both type 1 and type 2 diabetes mellitus (T2DM) patients. Notably, diabetic neuropathy can manifest even at the onset of type 2 diabetes mellitus. Peripheral neuropathy stands as the most common subtype of diabetic neuropathy, impacting nearly half of all individuals with diabetes over their lifetimes, as per recent guidelines. The development of diabetic neuropathy (DN) involves various metabolic and cellular processes, including inflammation and oxidative stress. Inflammation, characterized by cytokines and inflammatory cells, plays a role in diabetic neuropathy progression. Reactive oxygen species (ROS) contribute significantly, with low levels of antioxidants exacerbating the condition. Accumulation of advanced glycation end products (AGEs) further damages nerves. diabetic neuropathy leads to significant pain and discomfort for patients, yet current treatments often fall short of expectations. Improving treatment strategies is crucial to relieve suffering and improve the well-being of those affected by diabetic neuropathy. Piracetam shows promise in managing diabetic neuropathy (DN) based on both preclinical and clinical studies. It may enhance central nervous system function by influencing neurotransmitter release, potentially alleviating diabetic neuropathy symptoms. Additionally, piracetam's neuroprotective properties could shield nerve cells from oxidative stress and inflammation, which are key contributors to diabetic neuropathy nerve damage.",[68],"Diabetic Peripheral Neuropathy",[70,71,23],"Diabetes","Peripheral Neuropathy","NOT_YET_RECRUITING","2025-01-27",{"date":75,"type":76},"2025-01-28","ACTUAL",{"date":78,"type":62},"2025-02-10",{"date":80,"type":62},"2025-11-01",{"name":5,"class":6}]