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A Study to Assess the Safety and Efficacy of Centhaquine in Hypovolemic Shock Patients
Sponsor: Pharmazz, Inc.
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2021-08-13
Completion Date
2026-08
Last Updated
2025-12-31
Healthy Volunteers
No
Conditions
Interventions
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\<0.0001), lactate levels (p=0.0012) and base-deficit (p\<0.0001). 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.
Locations (17)
ACSR Government Medical College and Hospital
Nellore, Andhra Pradesh, India
All India Institute of Medical Sciences (AIIMS)
Raipur, Chhattisgarh, India
Aman Hospital
Vadodara, Gujarat, India
New Era Hospital
Nagpur, Maharashtra, India
Seven Star Hospital
Nagpur, Maharashtra, India
Meditrina Hospital
Nagpur, Maharashtra, India
Sri Guru Ram Das University of Health Sciences (SGRDH)
Amritsar, Punjab, India
Dayanand Medical College & Hospital (DMCH)
Ludhiana, Punjab, India
Christian Medical College and Hospital (CMC)
Ludhiana, Punjab, India
Government Medical College
Kota, Rajasthan, India
KG Hospital
Coimbatore, Tamil Nadu, India
Pushpanjali Hospital
Agra, Uttar Pradesh, India
Maharani Laxmi Bai Medical College (MLBMC)
Jhānsi, Uttar Pradesh, India
Nirmal Hospital
Jhānsi, Uttar Pradesh, India
Ganesh Shankar Vidyarthi Memorial Medical College (GSVM)
Kanpur, Uttar Pradesh, India
Janta Hospital
Varanasi, Uttar Pradesh, India
IPGMER & SSKM Hospital
Kolkata, West Bengal, India