A Study to Assess the Safety and Efficacy of Centhaquine in Hypovolemic Shock Patients
Recruiting now · Phase 4
Conditions studied: Hypovolemic Shock
In brief
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.
Key facts
- Study ID
- NCT05956418
- Run by
- Pharmazz, Inc.
- People needed
- 400
- Starts
- 2021-08-13
- Expected to finish
- 2026-08-01
- Last updated by the study team
- 2025-12-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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.
Where it is running
- ACSR Government Medical College and Hospital — Nellore, Andhra Pradesh, India (enrolling)
- All India Institute of Medical Sciences (AIIMS) — Raipur, Chhattisgarh, India (enrolling)
- Aman Hospital — Vadodara, Gujarat, India (enrolling)
- New Era Hospital — Nagpur, Maharashtra, India (enrolling)
- Seven Star Hospital — Nagpur, Maharashtra, India (enrolling)
- Meditrina Hospital — Nagpur, Maharashtra, India (enrolling)
- Sri Guru Ram Das University of Health Sciences (SGRDH) — Amritsar, Punjab, India (enrolling)
- Dayanand Medical College & Hospital (DMCH) — Ludhiana, Punjab, India (enrolling)
- Christian Medical College and Hospital (CMC) — Ludhiana, Punjab, India (enrolling)
- Government Medical College — Kota, Rajasthan, India (enrolling)
- KG Hospital — Coimbatore, Tamil Nadu, India (enrolling)
- Pushpanjali Hospital — Agra, Uttar Pradesh, India (enrolling)
- Maharani Laxmi Bai Medical College (MLBMC) — Jhānsi, Uttar Pradesh, India (enrolling)
- Nirmal Hospital — Jhānsi, Uttar Pradesh, India (enrolling)
- Ganesh Shankar Vidyarthi Memorial Medical College (GSVM) — Kanpur, Uttar Pradesh, India (enrolling)
- Janta Hospital — Varanasi, Uttar Pradesh, India (enrolling)
- IPGMER & SSKM Hospital — Kolkata, West Bengal, India (enrolling)
Full record on ClinicalTrials.gov
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