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

PHASE4RecruitingINTERVENTIONAL
Enrollment

400

Participants

Timeline

Start Date

August 13, 2021

Primary Completion Date

November 30, 2025

Study Completion Date

December 31, 2025

Conditions
Hypovolemic Shock
Interventions
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\<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.

Trial Locations (17)

141001

RECRUITING

Dayanand Medical College & Hospital (DMCH), Ludhiana

141008

RECRUITING

Christian Medical College and Hospital (CMC), Ludhiana

143501

RECRUITING

Sri Guru Ram Das University of Health Sciences (SGRDH), Amritsar

208002

RECRUITING

Ganesh Shankar Vidyarthi Memorial Medical College (GSVM), Kanpur

221005

RECRUITING

Janta Hospital, Varanasi

282002

RECRUITING

Pushpanjali Hospital, Agra

284001

RECRUITING

Maharani Laxmi Bai Medical College (MLBMC), Jhānsi

284128

RECRUITING

Nirmal Hospital, Jhānsi

324010

RECRUITING

Government Medical College, Kota

390021

RECRUITING

Aman Hospital, Vadodara

440008

RECRUITING

New Era Hospital, Nagpur

440009

RECRUITING

Seven Star Hospital, Nagpur

440012

RECRUITING

Meditrina Hospital, Nagpur

492099

RECRUITING

All India Institute of Medical Sciences (AIIMS), Raipur

524004

RECRUITING

ACSR Government Medical College and Hospital, Nellore

641018

RECRUITING

KG Hospital, Coimbatore

700020,

RECRUITING

IPGMER & SSKM Hospital, Kolkata

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pharmazz, Inc.

INDUSTRY