[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100512743":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":25,"centralContacts":30,"locations":37,"responsibleParty":277,"collaborators":35,"id":279,"slug":280,"hasResults":281,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":35,"eligibilityCriteria":285,"healthyVolunteers":281,"sex":286,"minAge":287,"maxAge":35,"enrollmentInfo":288,"targetDuration":35,"studyType":291,"phases":292,"briefSummary":294,"conditions":295,"keywords":297,"overallStatus":40,"whyStopped":35,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":305,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":312,"locationsCount":313},{"fullName":5,"class":6},"Pharmazz, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Centhaquine (Dose: 0.01 mg\u002Fkg) + Standard of care","EXPERIMENTAL","Centhaquine will be administered intravenously after enrollment to hypovolemic shock patients with systolic arterial blood pressure ≤ 90 mmHg at presentation and continue to receive standard shock treatment. Centhaquine will be administered at a dose of 0.01 mg\u002Fkg of body weight, as an intravenous (IV) infusion over 1 hour in 100 mL of normal saline. Second dose of centhaquine will be administered if SBP falls below or remains below or equal to 90 mmHg but not before 4 hours of the previous dose and total doses per day (in 24 hours) will not exceed 3 doses. Centhaquine administration if needed will continue for two days post-enrollment. A minimum of 1 dose or maximum of 6 doses of centhaquine will be administered within first 48 hours post-enrollment. Each patient will be monitored closely throughout his\u002Fher hospitalization and will be followed until discharge or day 7 (whichever is earlier) from enrollment.",[13],"Drug: Centhaquine",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Centhaquine","Centhaquine (LYFAQUIN™ or centhaquine citrate) is a novel, first-in-class, highly effective resuscitative agent for hypovolemic shock. Phase II results demonstrate highly significant efficacy in improving blood pressure (p\\\u003C0.0001), lactate levels (p=0.0012) and base-deficit (p\\\u003C0.0001). There was also improvement in reduction in use of vasopressors and reduced mortality. Similarly, results of phase III study confirmed the safety and efficacy of centhaquine as an adjuvant to standard of care for hypovolemic shock. Therefore, to assess safety of centhaquine in large population a phase IV study (post-authorization safety study) has been designed.",[9],[21,22,23,24],"LYFAQUIN™","Centhaquine Citrate","2-(2-(4-(3-methylphenyl)-1-piperazinyl)ethyl) quinoline citrate","PMZ-2010",[26],{"name":27,"affiliation":28,"role":29},"Manish Lavhale, Ph.D.","Pharmazz India","STUDY_DIRECTOR",[31],{"name":32,"role":33,"phone":34,"phoneExt":35,"email":36},"Dharmesh Shah, Dr.","CONTACT","+91(120)256-9779",null,"dharmesh.shah@pharmazz.com",[38,57,72,87,102,113,124,139,153,164,179,194,209,223,234,248,262],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"ACSR Government Medical College and Hospital","RECRUITING","Nellore","Andhra Pradesh","524004","India","IN",{"type":47,"coordinates":48},"Point",[49,50],79.98697,14.44992,{"lat":50,"lon":49},[53],{"name":54,"role":33,"phone":55,"phoneExt":35,"email":56},"SK. Noushad Ali, Dr.","9494828694","mddbnoal@gmail.com",{"facility":58,"status":40,"city":59,"state":60,"zip":61,"country":44,"countryCode":45,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"All India Institute of Medical Sciences (AIIMS)","Raipur","Chhattisgarh","492099",{"type":47,"coordinates":63},[64,65],81.63333,21.23333,{"lat":65,"lon":64},[68],{"name":69,"role":33,"phone":70,"phoneExt":35,"email":71},"Pugazhenthan Thangaraju, Dr.","9522582834","drpugal23@gmail.com",{"facility":73,"status":40,"city":74,"state":75,"zip":76,"country":44,"countryCode":45,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Aman Hospital","Vadodara","Gujarat","390021",{"type":47,"coordinates":78},[79,80],73.20812,22.29941,{"lat":80,"lon":79},[83],{"name":84,"role":33,"phone":85,"phoneExt":35,"email":86},"Aman Khanna, Dr.","9904402122","amankhanna1974@gmail.com",{"facility":88,"status":40,"city":89,"state":90,"zip":91,"country":44,"countryCode":45,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"New Era Hospital","Nagpur","Maharashtra","440008",{"type":47,"coordinates":93},[94,95],79.08491,21.14631,{"lat":95,"lon":94},[98],{"name":99,"role":33,"phone":100,"phoneExt":35,"email":101},"Nilesh Agrawal, Dr.","8888667808","anileshr@gmail.com",{"facility":103,"status":40,"city":89,"state":90,"zip":104,"country":44,"countryCode":45,"cosmosGeoPoint":105,"geoPoint":107,"contacts":108},"Seven Star Hospital","440009",{"type":47,"coordinates":106},[94,95],{"lat":95,"lon":94},[109],{"name":110,"role":33,"phone":111,"phoneExt":35,"email":112},"Prashant Rahate, Dr.","9822464068","Prashantrahate84@yahoo.com",{"facility":114,"status":40,"city":89,"state":90,"zip":115,"country":44,"countryCode":45,"cosmosGeoPoint":116,"geoPoint":118,"contacts":119},"Meditrina Hospital","440012",{"type":47,"coordinates":117},[94,95],{"lat":95,"lon":94},[120],{"name":121,"role":33,"phone":122,"phoneExt":35,"email":123},"Ajay Bulle, Dr.","9921981109","ajaybulle@yahoo.com",{"facility":125,"status":40,"city":126,"state":127,"zip":128,"country":44,"countryCode":45,"cosmosGeoPoint":129,"geoPoint":133,"contacts":134},"Sri Guru Ram Das University of Health Sciences (SGRDH)","Amritsar","Punjab","143501",{"type":47,"coordinates":130},[131,132],74.87534,31.62234,{"lat":132,"lon":131},[135],{"name":136,"role":33,"phone":137,"phoneExt":35,"email":138},"Pooja Abbi","8968088773","pooja.monga259@gmail..com",{"facility":140,"status":40,"city":141,"state":127,"zip":142,"country":44,"countryCode":45,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"Dayanand Medical College & Hospital (DMCH)","Ludhiana","141001",{"type":47,"coordinates":144},[145,146],75.85379,30.91204,{"lat":146,"lon":145},[149],{"name":150,"role":33,"phone":151,"phoneExt":35,"email":152},"Dinesh Jain, Dr.","9815532533","drjaindinesh@yahoo.co.in",{"facility":154,"status":40,"city":141,"state":127,"zip":155,"country":44,"countryCode":45,"cosmosGeoPoint":156,"geoPoint":158,"contacts":159},"Christian Medical College and Hospital (CMC)","141008",{"type":47,"coordinates":157},[145,146],{"lat":146,"lon":145},[160],{"name":161,"role":33,"phone":162,"phoneExt":35,"email":163},"Parvez D Haque, Dr.","9872630178","pdhaque@gmail.com",{"facility":165,"status":40,"city":166,"state":167,"zip":168,"country":44,"countryCode":45,"cosmosGeoPoint":169,"geoPoint":173,"contacts":174},"Government Medical College","Kota","Rajasthan","324010",{"type":47,"coordinates":170},[171,172],75.83907,25.18254,{"lat":172,"lon":171},[175],{"name":176,"role":33,"phone":177,"phoneExt":35,"email":178},"Manoj Saluja, Dr.","9829183813","salujamanoj@yahoo.com",{"facility":180,"status":40,"city":181,"state":182,"zip":183,"country":44,"countryCode":45,"cosmosGeoPoint":184,"geoPoint":188,"contacts":189},"KG Hospital","Coimbatore","Tamil Nadu","641018",{"type":47,"coordinates":185},[186,187],76.96612,11.00555,{"lat":187,"lon":186},[190],{"name":191,"role":33,"phone":192,"phoneExt":35,"email":193},"Karthikeyan Natarajan, Dr.","8754404051","plb.karthik@gmail.com",{"facility":195,"status":40,"city":196,"state":197,"zip":198,"country":44,"countryCode":45,"cosmosGeoPoint":199,"geoPoint":203,"contacts":204},"Pushpanjali Hospital","Agra","Uttar Pradesh","282002",{"type":47,"coordinates":200},[201,202],78.01667,27.18333,{"lat":202,"lon":201},[205],{"name":206,"role":33,"phone":207,"phoneExt":35,"email":208},"Anil K Sharma, Dr.","8357077174","shroti.anil@gmail.com",{"facility":210,"status":40,"city":211,"state":197,"zip":212,"country":44,"countryCode":45,"cosmosGeoPoint":213,"geoPoint":217,"contacts":218},"Maharani Laxmi Bai Medical College (MLBMC)","Jhānsi","284001",{"type":47,"coordinates":214},[215,216],78.57994,25.45887,{"lat":216,"lon":215},[219],{"name":220,"role":33,"phone":221,"phoneExt":35,"email":222},"Anshul Jain, Dr.","7054057995","dranshuljain81@gmail.com",{"facility":224,"status":40,"city":211,"state":197,"zip":225,"country":44,"countryCode":45,"cosmosGeoPoint":226,"geoPoint":228,"contacts":229},"Nirmal Hospital","284128",{"type":47,"coordinates":227},[215,216],{"lat":216,"lon":215},[230],{"name":231,"role":33,"phone":232,"phoneExt":35,"email":233},"Deo Nidhi Mishra, Dr.","9415031689","drmishra.nirmal@gmail.com",{"facility":235,"status":40,"city":236,"state":197,"zip":237,"country":44,"countryCode":45,"cosmosGeoPoint":238,"geoPoint":242,"contacts":243},"Ganesh Shankar Vidyarthi Memorial Medical College (GSVM)","Kanpur","208002",{"type":47,"coordinates":239},[240,241],80.34975,26.46523,{"lat":241,"lon":240},[244],{"name":245,"role":33,"phone":246,"phoneExt":35,"email":247},"Richa Giri, Dr.","8400331045","krricha227@gmail.com",{"facility":249,"status":40,"city":250,"state":197,"zip":251,"country":44,"countryCode":45,"cosmosGeoPoint":252,"geoPoint":256,"contacts":257},"Janta Hospital","Varanasi","221005",{"type":47,"coordinates":253},[254,255],83.01041,25.31668,{"lat":255,"lon":254},[258],{"name":259,"role":33,"phone":260,"phoneExt":35,"email":261},"Manoj K Pal, Dr.","9198677778","manojpalvns@gmail.com",{"facility":263,"status":40,"city":264,"state":265,"zip":266,"country":44,"countryCode":45,"cosmosGeoPoint":267,"geoPoint":271,"contacts":272},"IPGMER & SSKM Hospital","Kolkata","West Bengal","700020,",{"type":47,"coordinates":268},[269,270],88.36304,22.56263,{"lat":270,"lon":269},[273],{"name":274,"role":33,"phone":275,"phoneExt":35,"email":276},"Sarbari Swaika","9434021722","dr.s.swaika@gmail.com",{"type":278,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100512743","phase-4-a-study-to-assess-the-safety-and-efficacy-of-centhaquine-in-hypovolemic-shock-patients-100512743",false,"NCT05956418","A Study to Assess the Safety and Efficacy of Centhaquine in Hypovolemic Shock Patients","A Prospective, Multi-centric, Open-labeled, Phase-IV Study to Assess Safety and Efficacy of LYFAQUIN™ (Centhaquine Citrate) as a Resuscitative Agent for Hypovolemic Shock to be Used as an Adjuvant to Standard Treatment of Shock","Inclusion Criteria\n\n• Adult hypovolemic shock patients aged 18 years or older admitted to the emergency room or ICU with systolic blood pressure ≤ 90 mmHg at presentation and continue to receive standard shock treatment. Blood Lactate level indicative of hypovolemic shock (\\>2.0 mmol\u002FL).\n\nExclusion Criteria\n\n* Development of any other terminal illness not associated with hypovolemic shock during the study duration.\n* Patient with altered consciousness not due to hypovolemic shock and comatose patient. • Known pregnancy.\n* Cardiopulmonary resuscitation (CPR) before enrollment.\n* Presence of a do not resuscitate order.\n* Patient is participating in another interventional study.\n* Patients with systemic diseases which were already present before having trauma, such as sepsis, cancer, chronic renal failure, liver failure, decompensated heart failure, or AIDS.","ALL","18 Years",{"count":289,"type":290},400,"ESTIMATED","INTERVENTIONAL",[293],"PHASE4","This is a prospective, multi-centric, open-labeled, phase-IV clinical study to evaluate the safety and efficacy of centhaquine citrate (LYFAQUIN™), a first-in-class drug for treating hypovolemic shock, a life-threatening condition caused by severe blood or fluid loss. Centhaquine has been found to be an effective resuscitative agent in rat, rabbit, and swine models of hemorrhagic shock. It has demonstrated the ability to decrease blood lactate levels, increase mean arterial pressure, enhance cardiac output, and reduce mortality rates. The increase in cardiac output during resuscitation is primarily attributed to an augmentation in stroke volume. Centhaquine exerts its effects by acting on the venous α2B-adrenergic receptors, which enhances venous return to the heart. Additionally, it produces arterial dilation by targeting central α2A-adrenergic receptors, thereby reducing sympathetic activity and systemic vascular resistance.",[296],"Hypovolemic Shock",[298,299,300,301,302,17,303],"Shock","Hypovolemia","Hemorrhage","Blood Pressure","Resuscitation","Adrenergic","2025-12-26",{"date":306,"type":307},"2025-12-31","ACTUAL",{"date":309,"type":307},"2021-08-13",{"date":311,"type":290},"2026-08",{"name":5,"class":6},17]