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RECRUITING Phase 4 ClinicalTrials.gov

A Study to Assess the Safety and Efficacy of Centhaquine in Hypovolemic Shock Patients

Sponsor: Pharmazz, Inc. • ClinicalTrials.gov ID: NCT05956418

Registry updated: 2026-09-17
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Description

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.

Interventions

  • Centhaquine (Drug)
    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.

Eligibility criteria

Inclusion Criteria • 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/L). Exclusion Criteria * Development of any other terminal illness not associated with hypovolemic shock during the study duration. * Patient with altered consciousness not due to hypovolemic shock and comatose patient. • Known pregnancy. * Cardiopulmonary resuscitation (CPR) before enrollment. * Presence of a do not resuscitate order. * Patient is participating in another interventional study. * 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.

Conditions

Hypovolemic Shock

Locations

  • 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
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record