[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656535":3},{"organization":4,"outcomesModule":7,"designInfo":48,"detailedDescription":54,"studyPopulation":47,"armGroups":55,"interventions":68,"overallOfficials":47,"centralContacts":47,"locations":81,"responsibleParty":122,"collaborators":47,"id":124,"slug":125,"hasResults":126,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":126,"sex":132,"minAge":133,"maxAge":134,"enrollmentInfo":135,"targetDuration":47,"studyType":138,"phases":139,"briefSummary":141,"conditions":142,"keywords":148,"overallStatus":84,"whyStopped":47,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":163},{"fullName":5,"class":6},"EVD Pharmacy and Medical Company Limited","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":26,"otherOutcomes":47},[9,13,16,19,23],{"measure":10,"description":11,"timeFrame":12},"EuroQol 5-Dimension 5-Level (EQ-5D-5L)","The EQ-5D-5L is a patient-reported measure of health-related quality of life covering five dimensions: mobility, self-care, usual activities, pain\u002Fdiscomfort, and anxiety\u002Fdepression. Each dimension has five levels of response, ranging from 1 (no problems) to 5 (extreme problems\u002Funable to perform), with higher levels indicating worse health status.","Baseline, Day 7 and Day 14",{"measure":14,"description":15,"timeFrame":12},"EuroQol Visual Analogue Scale (EQ-VAS)","The EQ-VAS records the participant's self-rated health on a vertical visual analogue scale ranging from 0 to 100, where 0 represents the worst health the participant can imagine and 100 represents the best health the participant can imagine.",{"measure":17,"description":18,"timeFrame":12},"Treatment Satisfaction Questionnaire for Medication Version 1.4 (TSQM-1.4)","The Treatment Satisfaction Questionnaire for Medication Version 1.4 (TSQM-1.4) is a 14-item patient-reported questionnaire used to assess treatment satisfaction across four domains: effectiveness (3 items), side effects (5 items), convenience (3 items), and global satisfaction (3 items). Items use 5- or 7-point Likert-type response scales and dichotomous (Yes\u002FNo) responses, as applicable. TSQM 1.4 domain scores range from 0 to 100, with higher scores representing higher satisfaction in that domain.",{"measure":20,"description":21,"timeFrame":22},"Adverse Events","Frequency, incidence rate, and severity of adverse events during the study period.","From baseline through Week 12, and at the optional Week 24 follow-up visit.",{"measure":24,"description":25,"timeFrame":22},"Hemorrhagic Complications","Presence or absence of hemorrhagic complications during the study period.",[27,31,35,39,43],{"measure":28,"description":29,"timeFrame":30},"Modified Rankin Scale (mRS)","The modified Rankin Scale (mRS) is used to assess the degree of disability or dependence in daily activities following stroke. Scores range from 0 (no symptoms) to 6 (death).","Baseline, Week 4 and Week 12",{"measure":32,"description":33,"timeFrame":34},"Fugl-Meyer Assessment (FMA)","The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation, and joint functioning following stroke. The total score ranges from 0 to 226, with higher scores indicating better functional performance and less impairment.","Baseline, Day 14, Week 4 and Week 12",{"measure":36,"description":37,"timeFrame":38},"National Institutes of Health Stroke Scale (NIHSS)","The National Institutes of Health Stroke Scale (NIHSS) is used to assess neurological impairment following stroke. Scores range from 0 to 42, with higher scores indicating greater neurological impairment.","Baseline, Day 14 and Week 12",{"measure":40,"description":41,"timeFrame":42},"Maximum Muscle Strength","Maximum muscle strength will be assessed using the Mobie fixed-belt hand-held dynamometer.","Baseline, Day 7, Day 14, Day 21, Week 4, Week 8 and Week 12",{"measure":44,"description":45,"timeFrame":46},"Cerebral Infarct Volume on Magnetic Resonance Imaging (MRI)","Change in cerebral infarct volume from baseline will be assessed using magnetic resonance imaging (MRI).","Baseline and Week 12 (±7 days)",null,{"allocation":49,"interventionModel":50,"interventionModelDescription":47,"primaryPurpose":51,"observationalModel":47,"timePerspective":47,"maskingInfo":52},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":53,"maskingDescription":47,"whoMasked":47},"NONE","A total of 80 patients will be included, with approximately 40 patients randomized to each treatment group.\n\nGroup 1: Participants will receive MLC901 (400 mg, 2 capsules per dose, 3 times daily) in combination with standard treatment according to the protocol.\n\nGroup 2: Participants will receive standard treatment according to the protocol.\n\nThe treatment period will last for 12 weeks. An optional follow-up visit at Week 24 may be conducted to assess the durability of the treatment effect.\n\nEfficacy assessments will include the EuroQol 5-Dimension 5-Level (EQ-5D-5L), EuroQol Visual Analogue Scale (EQ-VAS), Treatment Satisfaction Questionnaire for Medication Version 1.4 (TSQM-1.4), Fugl-Meyer Assessment (FMA), National Institutes of Health Stroke Scale (NIHSS), modified Rankin Scale (mRS), muscle strength assessment, and MRI-based assessment of cerebral infarct volume.\n\nSafety will be assessed throughout the study through the monitoring of adverse events and hemorrhagic complications.",[56,63],{"label":57,"type":58,"description":59,"interventionNames":60},"MLC901 (NeuroAiD™ II) + Standard Treatment","EXPERIMENTAL","Participants will receive MLC901 (NeuroAiD™ II) (400 mg, 2 capsules per dose, 3 times daily) in combination with standard treatment according to the protocol for 12 weeks.",[61,62],"Drug: MLC901","Other: Standard treatment for acute ischemic stroke",{"label":64,"type":65,"description":66,"interventionNames":67},"Standard Treatment","ACTIVE_COMPARATOR","Participants will receive standard treatment according to the protocol for 12 weeks.",[62],[69,76],{"type":70,"name":71,"description":72,"armGroupLabels":73,"otherNames":74},"DRUG","MLC901","MLC901 (NeuroAiD™ II) 400 mg hard capsules, administered orally at a dose of 2 capsules three times daily for 12 weeks, in combination with standard treatment according to the protocol.",[57],[75],"NeuroAiD™ II",{"type":77,"name":78,"description":79,"armGroupLabels":80,"otherNames":47},"OTHER","Standard treatment for acute ischemic stroke","Participants will receive standard treatment for acute ischemic stroke according to the study protocol for 12 weeks",[57,64],[82],{"facility":83,"status":84,"city":85,"state":47,"zip":47,"country":86,"countryCode":87,"cosmosGeoPoint":88,"geoPoint":93,"contacts":94},"Traditional Medicine Institute","RECRUITING","Ho Chi Minh City","Vietnam","VN",{"type":89,"coordinates":90},"Point",[91,92],106.62965,10.82302,{"lat":92,"lon":91},[95,100,102,105,108,110,112,114,116,118,120],{"name":96,"role":97,"phone":98,"phoneExt":47,"email":99},"Thi Lan Huong Dinh, MD","CONTACT","+84 983 699 665","dinhlanhuonghmu@gmail.com",{"name":101,"role":97,"phone":47,"phoneExt":47,"email":47},"Thanh Tuyen Nguyen",{"name":103,"role":104,"phone":47,"phoneExt":47,"email":47},"Nguyen Hao Nhien Le","PRINCIPAL_INVESTIGATOR",{"name":106,"role":107,"phone":47,"phoneExt":47,"email":47},"Le Anh Trung Nguyen","SUB_INVESTIGATOR",{"name":109,"role":107,"phone":47,"phoneExt":47,"email":47},"Tri Cuong Nguyen",{"name":111,"role":107,"phone":47,"phoneExt":47,"email":47},"Thi My Phuong Ho",{"name":113,"role":107,"phone":47,"phoneExt":47,"email":47},"Dinh Hung Nguyen",{"name":115,"role":107,"phone":47,"phoneExt":47,"email":47},"Thi Phuoc Hoa Ta",{"name":117,"role":107,"phone":47,"phoneExt":47,"email":47},"Ngoc Ha Phuong Dang",{"name":119,"role":107,"phone":47,"phoneExt":47,"email":47},"Le Bao Quyen Nguyen",{"name":121,"role":104,"phone":47,"phoneExt":47,"email":47},"Thi Lan Huong Dinh",{"type":123,"investigatorFullName":47,"investigatorTitle":47,"investigatorAffiliation":47,"oldNameTitle":47,"oldOrganization":47},"SPONSOR","100656535","phase-4-neuroaid-patient-reported-outcomes-in-patients-with-mild-to-moderate-ischemic-stroke-100656535",false,"NCT07828210","NeuroAiD Patient-Reported Outcomes in Patients With Mild to Moderate Ischemic Stroke","A Randomized, Controlled Study Evaluating the Efficacy and Safety of MLC901 (NeuroAiD™ II) in Patients With Mild to Moderate Ischemic Stroke.","NAiD-PRO","Inclusion Criteria:\n\n1. Male or female.\n2. Aged 18 to 80 years, inclusive.\n3. Diagnosed with ischemic stroke, with brain imaging findings consistent with the diagnosis, and enrolled 2-10 days after stroke onset.\n4. Baseline National Institutes of Health Stroke Scale (NIHSS) score of 1-15 at the time of screening.\n5. Clinically stable at the time of enrollment.\n6. Considered by the treating physician to be a suitable candidate for active rehabilitation.\n7. Able to comply with the requirements of the study protocol and has provided written informed consent to participate in the study, either personally or through a legally authorized representative, as applicable, before any study-specific procedures are performed.\n\nExclusion Criteria:\n\n1. Other neurological or psychiatric disorders that may interfere with study assessments, including:\n\n   * Hemorrhagic stroke.\n   * Evidence of other significant non-ischemic brain lesions that may affect long-term functional outcomes or disability.\n   * Evidence of progressive medical conditions that may interfere with study assessments or follow-up (e.g., cancer, kidney failure, liver cirrhosis, severe dementia, or psychiatric disorders).\n   * Any medical, psychiatric, or cognitive condition that, in the investigator's opinion, may place the participant at risk during study participation, interfere with the conduct of study procedures, compromise study follow- up, or confound the study results.\n2. Contraindication to any study procedure.\n3. Clinically unstable condition within 24 hours after thrombolysis (intravenous\u002Fendovascular) or thrombectomy.\n4. Use of Cerebrolysin, piracetam, erythropoietin, edaravone, or vinpocetine within 30 days prior to enrollment.\n5. Current use of finished medicinal products or herbal medicinal products containing ingredients that overlap with any component of MLC901.\n6. Participation in another investigational drug or medical device trial within 30 days prior to enrollment.\n7. Pregnancy or breastfeeding. Women of childbearing potential are eligible only if they commit to complete abstinence from sexual intercourse or use effective contraception (excluding systemic hormonal contraceptives). Participants receiving hormone replacement therapy are not eligible (this applies to premenopausal, postmenopausal, or surgically sterilized women).\n8. History of food allergy or hypersensitivity to any component of MLC901","ALL","18 Years","80 Years",{"count":136,"type":137},80,"ESTIMATED","INTERVENTIONAL",[140],"PHASE4","This is a randomized, controlled, open-label study of MLC901 (NeuroAiD™ II) in patients with mild to moderate ischemic stroke. Eligible participants will be randomized in a 1:1 ratio to receive MLC901 in combination with standard treatment or standard treatment alone for 12 weeks.",[143,144,145,146,147],"Stroke","Stroke, Acute Ischemic","Stroke, Ischemic","Stroke, Cryptogenic","Stroke, Cardiovascular",[71,130,149,150,151,152,153],"stroke recovery","neurorestoration","NeuroAiD II","ischemic stroke","stroke","2026-09-27",{"date":156,"type":157},"2026-09-30","ACTUAL",{"date":159,"type":157},"2026-09-10",{"date":161,"type":137},"2027-12",{"name":5,"class":6},1]