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A Study to Assess Safety and Efficacy of Centhaquine as a Resuscitative Agent
Sponsor: Pharmazz, Inc.
Summary
This protocol is designed to develop a novel first-in-class treatment for use in critical care and life-threatening condition of hypovolemic shock with unmet need and is of national interest. Shock is a life-threatening condition of circulatory failure. It is a state of cellular and tissue hypoxia due to reduced oxygen delivery and/or increased oxygen consumption or inadequate oxygen utilization. Shock most commonly occurs when there is circulatory failure leading to reduced tissue perfusion. There are four types of shock: distributive, cardiogenic, hypovolemic, and obstructive. However, these are not exclusive, and many patients with circulatory failure have a combination of more than one form of shock (multifactorial shock).
Official title: A Multi-Centric, Randomized, Double-Blind, Placebo-controlled, Phase-III Study to Assess Safety and Efficacy of Centhaquine as a Resuscitative Agent to be Used as an Adjuvant to Standard Treatment of Hypovolemic Shock
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
430
Start Date
2026-02
Completion Date
2027-10
Last Updated
2025-12-30
Healthy Volunteers
No
Conditions
Interventions
Normal Saline
Normal Saline to be Used as Vehicle in the Phase-III Study to Assess Efficacy of Centhaquine as a Resuscitative Agent for Hypovolemic Shock
Centhaquine
Phase-III Study to Assess Efficacy of Centhaquine as a Resuscitative Agent for Hypovolemic Shock