Assessing Centhaquine for treating hypovolemic shock
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
Run by Pharmazz, Inc. · NCT05956418 · Data updated 2026-11-12
This study is testing if a new treatment called centhaquine can help adults with hypovolemic shock feel better and survive longer when used with standard care.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | Pharmazz, Inc. Industry-sponsored |
| Locations | 17 sites (Nellore, Andhra Pradesh and 16 other locations) |
| Status | Recruiting |
| Started | August 13, 2021 |
| Main results expected | November 2026 |
| Study ends | February 2027 |
| Registry record updated | September 17, 2026 |
| Trial ID | NCT05956418 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with hypovolemic shock and a systolic blood pressure of 90 mmHg or lower upon hospital admission.
✕Probably not a fit
Patients with terminal illnesses unrelated to hypovolemic shock, altered consciousness, or those who have undergone CPR prior to enrollment may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the safety and efficacy of centhaquine citrate, a novel treatment for hypovolemic shock, in approximately 400 adult patients. Participants will receive centhaquine alongside standard shock treatment, including fluid resuscitation and vasopressors, while being closely monitored throughout their hospitalization. The study aims to determine if centhaquine can improve blood pressure, reduce lactate levels, and ultimately decrease mortality rates in these patients. The drug works by enhancing venous return to the heart and producing arterial dilation, which may improve cardiac output during resuscitation.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for patients suffering from hypovolemic shock.
How similar studies have gone: While centhaquine has shown promise in animal models, this study represents a novel approach in human subjects for treating hypovolemic shock.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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ACSR Government Medical College and Hospital
Nellore, Andhra Pradesh, India Recruiting -
All India Institute of Medical Sciences (AIIMS)
Raipur, Chhattisgarh, India Recruiting -
Aman Hospital
Vadodara, Gujarat, India Recruiting -
New Era Hospital
Nagpur, Maharashtra, India Recruiting -
Seven Star Hospital
Nagpur, Maharashtra, India Recruiting -
Meditrina Hospital
Nagpur, Maharashtra, India Recruiting
Show 11 more locations
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Sri Guru Ram Das University of Health Sciences (SGRDH)
Amritsar, Punjab, India Recruiting -
Dayanand Medical College & Hospital (DMCH)
Ludhiana, Punjab, India Recruiting -
Christian Medical College and Hospital (CMC)
Ludhiana, Punjab, India Recruiting -
Government Medical College
Kota, Rajasthan, India Recruiting -
KG Hospital
Coimbatore, Tamil Nadu, India Recruiting -
Pushpanjali Hospital
Agra, Uttar Pradesh, India Recruiting -
Maharani Laxmi Bai Medical College (MLBMC)
Jhānsi, Uttar Pradesh, India Recruiting -
Nirmal Hospital
Jhānsi, Uttar Pradesh, India Recruiting -
Ganesh Shankar Vidyarthi Memorial Medical College (GSVM)
Kanpur, Uttar Pradesh, India Recruiting -
Janta Hospital
Varanasi, Uttar Pradesh, India Recruiting -
IPGMER & SSKM Hospital
Kolkata, West Bengal, India Recruiting
Study contacts
- Study coordinator: Dharmesh Shah, Dr.
- Email: dharmesh.shah@pharmazz.com
- Phone: +91(120)256-9779
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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-
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.