NCT04045327

Efficacy of PMZ-2010 (Centhaquine) a Resuscitative Agent for Hypovolemic Shock

Completed Phase 3 Last updated 4 October 2019

What this trial tests

Phase 3 trial testing Normal saline + Standard Treatment in Hypovolemic Shock in 105 participants. Completed in 27 September 2019.

Timeline

31 January 2019

Primary endpoint
23 September 2019

27 September 2019

Quick facts

Lead sponsor	Pharmazz, Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	105
Start date	31 January 2019
Primary completion	23 September 2019
Estimated completion	27 September 2019
Sites	18 locations across India

Drugs / interventions tested

• Normal saline + Standard Treatment — full drug profile →
• Centhaquine + Standard Treatment — full drug profile →

Conditions studied

• Hypovolemic Shock — all drugs for Hypovolemic Shock →

Sponsor

Pharmazz, Inc. — full company profile →

Who can join

18 and older, any sex, with Hypovolemic Shock. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a prospective, multi-centric, randomized, double-blind, parallel, controlled phase-III efficacy clinical study of PMZ-2010 therapy in patients with hypovolemic shock.

Centhaquine (previously used names, centhaquin and PMZ-2010; International Non-proprietary Name (INN) recently approved by WHO is centhaquine) has been found to be an effective resuscitative agent in rat, rabbit and swine models of hemorrhagic shock, it decreased blood lactate, increased mean arterial pressure, cardiac output, and decreased mortality. An increase in cardiac output during resuscitation is mainly attributed to an increase in stroke volume. Centhaquine acts on the venous α2B-adrenergic receptors and enhances venous return to the heart, in addition, it produces arterial dilatation by acting on central α2A-adrenergic receptors to reduce sympathetic activity and systemic vascular resistance.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Controls of Central and Peripheral Blood Pressure and Hemorrhagic/Hypovolemic Shock.
   Ranjan AK, Gulati A. · · 2023 · cited 17× · PMID 36769755 · DOI 10.3390/jcm12031108
2. Shear Stress and Endothelial Mechanotransduction in Trauma Patients with Hemorrhagic Shock: Hidden Coagulopathy Pathways and Novel Therapeutic Strategies.
   Chalkias A. · · 2023 · cited 14× · PMID 38139351 · DOI 10.3390/ijms242417522
3. A Multicentric, Randomized, Controlled Phase III Study of Centhaquine (Lyfaquin^®) as a Resuscitative Agent in Hypovolemic Shock Patients.
   Gulati A, Choudhuri R, Gupta A, Singh S, et al · · 2021 · cited 14× · PMID 34061314 · DOI 10.1007/s40265-021-01547-5
4. Resuscitative Effect of Centhaquine (Lyfaquin^®) in Hypovolemic Shock Patients: A Randomized, Multicentric, Controlled Trial.
   Gulati A, Jain D, Agrawal NR, Rahate P, et al · · 2021 · cited 13× · PMID 33970455 · DOI 10.1007/s12325-021-01760-4
5. Centhaquine Restores Renal Blood Flow and Protects Tissue Damage After Hemorrhagic Shock and Renal Ischemia.
   Ranjan AK, Zhang Z, Briyal S, Gulati A. · · 2021 · cited 11× · PMID 34012389 · DOI 10.3389/fphar.2021.616253
6. Role of adrenergic receptors in shock.
   Geevarghese M, Patel K, Gulati A, Ranjan AK. · · 2023 · cited 8× · PMID 36726848 · DOI 10.3389/fphys.2023.1094591
7. Therapeutic Potential of Centhaquine Citrate, a Selective Alpha-2B Adrenoceptor Agonist, in the Management of Circulatory Shock.
   Legrand M, Ranjan A, Rammohan S, De Backer D, et al · · 2025 · cited 1× · PMID 40253656 · DOI 10.1007/s40265-025-02176-y
8. Centhaquine Increases Stroke Volume and Cardiac Output in Patients with Hypovolemic Shock
   Khanna A, Vaidya K, Shah D, Ranjan A, et al · · 2024