Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT05956418

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

Led by Pharmazz, Inc. · Updated on 2025-12-31

400

Participants Needed

17

Research Sites

259 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult hypovolemic shock patients aged 18 years or older admitted to the emergency room or ICU with systolic blood pressure 64 90 mmHg at presentation and continue to receive standard shock treatment
  • Blood Lactate level indicative of hypovolemic shock (>2.0 mmol/L)
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 17 locations

1

ACSR Government Medical College and Hospital

Nellore, Andhra Pradesh, India, 524004

Actively Recruiting

2

All India Institute of Medical Sciences (AIIMS)

Raipur, Chhattisgarh, India, 492099

Actively Recruiting

3

Aman Hospital

Vadodara, Gujarat, India, 390021

Actively Recruiting

4

New Era Hospital

Nagpur, Maharashtra, India, 440008

Actively Recruiting

5

Seven Star Hospital

Nagpur, Maharashtra, India, 440009

Actively Recruiting

6

Meditrina Hospital

Nagpur, Maharashtra, India, 440012

Actively Recruiting

7

Sri Guru Ram Das University of Health Sciences (SGRDH)

Amritsar, Punjab, India, 143501

Actively Recruiting

8

Dayanand Medical College & Hospital (DMCH)

Ludhiana, Punjab, India, 141001

Actively Recruiting

9

Christian Medical College and Hospital (CMC)

Ludhiana, Punjab, India, 141008

Actively Recruiting

10

Government Medical College

Kota, Rajasthan, India, 324010

Actively Recruiting

11

KG Hospital

Coimbatore, Tamil Nadu, India, 641018

Actively Recruiting

12

Pushpanjali Hospital

Agra, Uttar Pradesh, India, 282002

Actively Recruiting

13

Maharani Laxmi Bai Medical College (MLBMC)

Jhānsi, Uttar Pradesh, India, 284001

Actively Recruiting

14

Nirmal Hospital

Jhānsi, Uttar Pradesh, India, 284128

Actively Recruiting

15

Ganesh Shankar Vidyarthi Memorial Medical College (GSVM)

Kanpur, Uttar Pradesh, India, 208002

Actively Recruiting

16

Janta Hospital

Varanasi, Uttar Pradesh, India, 221005

Actively Recruiting

17

IPGMER & SSKM Hospital

Kolkata, West Bengal, India, 700020,

Actively Recruiting

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Research Team

D

Dharmesh Shah, Dr.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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