Hypovolemic ShockPhase 4NCT05956418
A Study to Assess the Safety and Efficacy of Centhaquine in Hypovolemic Shock Patients
A Phase 4 study testing Centhaquine in people with Hypovolemic Shock, run by Pharmazz, Inc. at 17 sites in India.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypovolemic Shock
- What is being tested?
- Centhaquine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 17 sitesIndia
- Study dates
- 13 Aug 2021to Feb 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
17 sites in 1 country
India17 sites, 17 recruiting
- Recruiting
Pushpanjali Hospital
Agra, Uttar Pradesh, 282002
Anil K Sharma, Dr., 8357077174, shroti.anil@gmail.com
- Recruiting
Sri Guru Ram Das University of Health Sciences (SGRDH)
Amritsar, Punjab, 143501
Pooja Abbi, 8968088773, pooja.monga259@gmail..com
- Recruiting
KG Hospital
Coimbatore, Tamil Nadu, 641018
Karthikeyan Natarajan, Dr., 8754404051, plb.karthik@gmail.com
- Recruiting
Maharani Laxmi Bai Medical College (MLBMC)
Jhānsi, Uttar Pradesh, 284001
Anshul Jain, Dr., 7054057995, dranshuljain81@gmail.com
- Recruiting
Nirmal Hospital
Jhānsi, Uttar Pradesh, 284128
Deo Nidhi Mishra, Dr., 9415031689, drmishra.nirmal@gmail.com
- Recruiting
Ganesh Shankar Vidyarthi Memorial Medical College (GSVM)
Kanpur, Uttar Pradesh, 208002
Richa Giri, Dr., 8400331045, krricha227@gmail.com
- Recruiting
IPGMER & SSKM Hospital
Kolkata, West Bengal, 700020,
Sarbari Swaika, 9434021722, dr.s.swaika@gmail.com
- Recruiting
Government Medical College
Kota, Rajasthan, 324010
Manoj Saluja, Dr., 9829183813, salujamanoj@yahoo.com
- Recruiting
Dayanand Medical College & Hospital (DMCH)
Ludhiana, Punjab, 141001
Dinesh Jain, Dr., 9815532533, drjaindinesh@yahoo.co.in
- Recruiting
Christian Medical College and Hospital (CMC)
Ludhiana, Punjab, 141008
Parvez D Haque, Dr., 9872630178, pdhaque@gmail.com
- Recruiting
New Era Hospital
Nagpur, Maharashtra, 440008
Nilesh Agrawal, Dr., 8888667808, anileshr@gmail.com
- Recruiting
Seven Star Hospital
Nagpur, Maharashtra, 440009
Prashant Rahate, Dr., 9822464068, Prashantrahate84@yahoo.com
- Recruiting
Meditrina Hospital
Nagpur, Maharashtra, 440012
Ajay Bulle, Dr., 9921981109, ajaybulle@yahoo.com
- Recruiting
ACSR Government Medical College and Hospital
Nellore, Andhra Pradesh, 524004
SK. Noushad Ali, Dr., 9494828694, mddbnoal@gmail.com
- Recruiting
All India Institute of Medical Sciences (AIIMS)
Raipur, Chhattisgarh, 492099
Pugazhenthan Thangaraju, Dr., 9522582834, drpugal23@gmail.com
- Recruiting
Aman Hospital
Vadodara, Gujarat, 390021
Aman Khanna, Dr., 9904402122, amankhanna1974@gmail.com
- Recruiting
Janta Hospital
Varanasi, Uttar Pradesh, 221005
Manoj K Pal, Dr., 9198677778, manojpalvns@gmail.com
About this study
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
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.
Read the detailed description
This study will enroll approximately 400 patients aged 18 years or older with hypovolemic shock and a systolic blood pressure of 90 mmHg or lower upon admission to the hospital. These patients will continue to receive standard shock treatment, including endotracheal intubation, fluid resuscitation, and vasopressors. The trial seeks to answer several key questions: Is centhaquine safe to use in patients with hypovolemic shock? Can centhaquine improve blood pressure, lactate levels, and base deficit, and reduce mortality? Participants will receive centhaquine in addition to the standard of care. Centhaquine will be administered intravenously in 100 mL of normal saline at a dose of 0.01 mg/kg of body weight over a period of one hour. A second dose will be given if the systolic blood pressure remains at or below 90 mmHg, but not before 4 hours have passed since the previous dose. The total number of doses within 24 hours will not exceed 3, and centhaquine administration may continue for up to two days after enrollment. Each patient will be closely monitored throughout their hospitalization and followed until discharge or up to seven days from enrollment, whichever comes first. The trial will assess safety and efficacy parameters according to a predefined schedule of visits. The baseline characteristics of the patients in different groups will be compared using statistical tests such as the Chi-square test for categorical variables and the Unpaired t-test for continuous variables. Changes in dichotomous variables between groups from baseline to follow-ups will be analyzed using McNemar's test. Survival rates will be measured using Kaplan-Meier survival analysis, and univariate and multiple Cox-regression analysis will be employed to determine hazard ratios and their 95% confidence intervals for patient survival. The trial results will be presented as mean±SEM (median, minimum, and maximum) values and percentages.
- Conditions
- Hypovolemic Shock
- Being tested
- Centhaquine
- Keywords
- Shock, Hypovolemia, Hemorrhage, Blood Pressure, Resuscitation, Centhaquine, Adrenergic
- Medical subject headings
- Shock, Hypovolemia, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CenthaquineDrug
Also called LYFAQUIN™, Centhaquine Citrate, 2-(2-(4-(3-methylphenyl)-1-piperazinyl)ethyl) quinoline citrate, PMZ-2010
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.
| Study group | Role | What they receive |
|---|---|---|
| Centhaquine (Dose: 0.01 mg/kg) + Standard of care | Experimental | Centhaquine will be administered intravenously after enrollment to hypovolemic shock patients with systolic arterial blood pressure ≤ 90 mmHg at presentation and continue to receive standard shock treatment. Centhaquine will be administered at a dose of 0.01 mg/kg of body weight, as an intravenous (IV) infusion over 1 hour in 100 mL of normal saline. Second dose of centhaquine will be administered if SBP falls below or remains below or equal to 90 mmHg but not before 4 hours of the previous dose and total doses per day (in 24 hours) will not exceed 3 doses. Centhaquine administration if needed will continue for two days post-enrollment. A minimum of 1 dose or maximum of 6 doses of centhaquine will be administered within first 48 hours post-enrollment. Each patient will be monitored closely throughout his/her hospitalization and will be followed until discharge or day 7 (whichever is earlier) from enrollment. Receives: Drug: Centhaquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with adverse events (AEs) and serious adverse events (SAEs)
Any unfavorable sign, symptom, or disease that occurs while using centhaquine will be reported as an adverse event (AE), including worsening of pre-existing medical conditions. A severe medical occurrence, such as death, life-threatening situations, hospitalization, significant disability, or congenital anomalies will be reported as a serious adverse event (SAE). AEs will be collected through patient questioning, spontaneous reports, and observation. Description, severity, start and end dates, incidence, relationship to the centhaquine, seriousness, action taken, and outcome of AEs will be documented in source documents and case report forms (CRFs). All SAEs will be reported within 24 hours to the sponsor, Drugs Controller General of India, and the ethics committee. Follow-up information and hospitalization or autopsy reports will be provided if necessary. A detailed analyzed report of all SAEs will be prepared and submitted to relevant authorities within 14 days.
Measured: Up to 7 days
Secondary outcomes (10)
Systolic and diastolic blood pressure
Hypovolemia is known to cause low blood pressure, severely. That may lead to multi-organ failure or death. Hence, improving blood pressure is the key to the development of effective hypovolemic shock therapeutics.
Measured: Up to 7 days
Blood lactate
Increased blood lactate level is indicative of hypovolemic shock. Lactate level of more than 2 mmol/L is correlated with increased tissue hypoxia and anaerobic respiration following shock.
Measured: 48 hours
Base-deficit
The base deficit is a known measure of metabolic acidosis and has been advocated as a marker of resuscitation adequacy. It is correlated with the severity of injury and degree of hemorrhage, which makes it useful in the operating room (OR) as an endpoint of resuscitation.
Measured: 48 hours
Time in intensive care unit (ICU)
In the intensive care unit, specific medical specialties will be provided to support the shock patients whose lives are in immediate danger. ICU medical interventions take over the function of defective or damaged organs and maintain blood pressure in shock patients.
Measured: Up to 7 days
Time on ventilator
Ventilatory support is commonly used to resolve the circulation problem in shock patients.
Measured: Up to 7 days
Urine output
The urine output is an important clinical parameter for renal function and blood volume status, especially in critically ill multiple trauma patients during their hospital admission and ICU. Also, it is a reliable incipient marker of hypovolemia therefore it has a place among the parameters used to monitor the hemodynamic status of critically ill multiple trauma patients.
Measured: 48 hours
Incidence of mortality
The hypovolemic shock causes ischemic injury to vital organs and may lead to multi-system organ failure and death (mortality).
Measured: 7 days
Multiple Organ Dysfunction Syndrome score (MODS)
Multiple organ dysfunction syndrome (MODS) is a life-threatening complication and a major cause of mortality in the injured patient. MODS is a 5-grade scale from 0 to 4, where 0 is the best and 4 is the worst outcome.
Measured: Up to 7 days
Acute Respiratory Distress Syndrome (ARDS)
Acute respiratory distress syndrome (ARDS) is a serious lung condition, which causes low blood oxygen. It is a complication of shock associated with hypovolemia, hypoxemia, and inadequate cardiovascular compensatory responses to increased O2 demands. It is preceded by hypovolemia, reduced heart function, inadequate O2 delivery, and extraction needed to maintain VO2 in injured patients with increased metabolic as well as O2 requirements.
Measured: Up to 7 days
Glasgow Coma Scale (GCS)
Glasgow Coma Scale (GCS) is a neurological scale consisting of the sum of three coded values: motor, verbal, and eye-opening. It provides a reliable way of recording the conscious state of a person or shock patient. GCS is a 15-point scale to assess the level of consciousness of patients where less than 3 is a comatose state and 15 is fully awake.
Measured: Up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start13 Aug 2021
- Primary completionNov 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Hypovolemic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, multi-centric, open-labeled, single-arm and phase-IV study in 400 hypovolemic shock patients with a systolic arterial blood pressure ≤ 90 mmHg. The study duration will be approximately 15 months, including a 12-month enrollment period. All patients in the single group of the study will receive treatment with "Centhaquine (Dose: 0.01 mg/kg) + Standard of care." A second dose of centhaquine may be given if the systolic blood pressure remains low. However, the maximum number of doses per day should not exceed 3, and if needed the treatment will continue for the 2nd day of enrollment. Within the first 48 hours post-enrollment, a minimum of 1 dose and a maximum of 6 doses of centhaquine will be administered. Each patient will be closely monitored throughout their hospitalization and followed until discharge or day 7 (whichever comes earlier) from enrollment.
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pharmazz, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Manish Lavhale, Ph.D., Study director, Pharmazz India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05956418
- Sponsor's protocol ID
- PMZ-2010/CT-4.1/2019
- Status last verified
- Dec 2025
- First submitted
- 30 Jun 2023
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Plan to publish the findings after completion of the study.
Publications
Lavhale MS, Havalad S, Gulati A. Resuscitative effect of centhaquin after hemorrhagic shock in rats. J Surg Res. 2013 Jan;179(1):115-24. doi: 10.1016/j.jss.2012.08.042. Epub 2012 Sep 2.
PubMed 22964270Geevarghese M 3rd, Patel K, Gulati A, Ranjan AK. Role of adrenergic receptors in shock. Front Physiol. 2023 Jan 16;14:1094591. doi: 10.3389/fphys.2023.1094591. eCollection 2023.
PubMed 36726848Papapanagiotou P, Xanthos T, Gulati A, Chalkias A, Papalois A, Kontouli Z, Alegakis A, Iacovidou N. Centhaquin improves survival in a swine model of hemorrhagic shock. J Surg Res. 2016 Jan;200(1):227-35. doi: 10.1016/j.jss.2015.06.056. Epub 2015 Jun 29.
PubMed 26216751Gulati A, Lavhale MS, Garcia DJ, Havalad S. Centhaquin improves resuscitative effect of hypertonic saline in hemorrhaged rats. J Surg Res. 2012 Nov;178(1):415-23. doi: 10.1016/j.jss.2012.02.005. Epub 2012 Apr 2.
PubMed 22487389Gulati A, Zhang Z, Murphy A, Lavhale MS. Efficacy of centhaquin as a small volume resuscitative agent in severely hemorrhaged rats. Am J Emerg Med. 2013 Sep;31(9):1315-21. doi: 10.1016/j.ajem.2013.05.032. Epub 2013 Jul 19.
PubMed 23871440Kontouli Z, Staikou C, Iacovidou N, Mamais I, Kouskouni E, Papalois A, Papapanagiotou P, Gulati A, Chalkias A, Xanthos T. Resuscitation with centhaquin and 6% hydroxyethyl starch 130/0.4 improves survival in a swine model of hemorrhagic shock: a randomized experimental study. Eur J Trauma Emerg Surg. 2019 Dec;45(6):1077-1085. doi: 10.1007/s00068-018-0980-1. Epub 2018 Jul 13.
PubMed 30006694Ranjan AK, Zhang Z, Briyal S, Gulati A. Centhaquine Restores Renal Blood Flow and Protects Tissue Damage After Hemorrhagic Shock and Renal Ischemia. Front Pharmacol. 2021 May 3;12:616253. doi: 10.3389/fphar.2021.616253. eCollection 2021.
PubMed 34012389Gulati A, Jain D, Agrawal NR, Rahate P, Choudhuri R, Das S, Dhibar DP, Prabhu M, Haveri S, Agarwal R, Lavhale MS. Resuscitative Effect of Centhaquine (Lyfaquin(R)) in Hypovolemic Shock Patients: A Randomized, Multicentric, Controlled Trial. Adv Ther. 2021 Jun;38(6):3223-3265. doi: 10.1007/s12325-021-01760-4. Epub 2021 May 10.
PubMed 33970455Gulati A, Choudhuri R, Gupta A, Singh S, Ali SKN, Sidhu GK, Haque PD, Rahate P, Bothra AR, Singh GP, Maheshwari S, Jeswani D, Haveri S, Agarwal A, Agrawal NR. A Multicentric, Randomized, Controlled Phase III Study of Centhaquine (Lyfaquin(R)) as a Resuscitative Agent in Hypovolemic Shock Patients. Drugs. 2021 Jun;81(9):1079-1100. doi: 10.1007/s40265-021-01547-5. Epub 2021 Jun 1.
PubMed 34061314Khanna A, Vaidya K, Shah D, Ranjan AK, Gulati A. Centhaquine Increases Stroke Volume and Cardiac Output in Patients with Hypovolemic Shock. J Clin Med. 2024 Jun 27;13(13):3765. doi: 10.3390/jcm13133765.
PubMed 38999331
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05956418
- Acronym / sponsor ID
- PMZ-2010/CT-4.1/2019
- Conditions
- Hypovolemic Shock
- Keywords
- Shock, Hypovolemia, Hemorrhage, Blood Pressure, Resuscitation, Centhaquine, Adrenergic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Pharmazz, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Aug 2021 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 21 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will enroll approximately 400 patients aged 18 years or older with hypovolemic shock and a systolic blood pressure of 90 mmHg or lower upon admission to the hospital. These patients will continue to receive standard shock treatment, including endotracheal intubation, fluid resuscitation, and vasopressors. The trial seeks to answer several key questions: Is centhaquine safe to use in patients with hypovolemic shock? Can centhaquine improve blood pressure, lactate levels, and base deficit, and reduce mortality? Participants will receive centhaquine in addition to the standard of care. Centhaquine will be administered intravenously in 100 mL of normal saline at a dose of 0.01 mg/kg of body weight over a period of one hour. A second dose will be given if the systolic blood pressure remains at or below 90 mmHg, but not before 4 hours have passed since the previous dose. The total number of doses within 24 hours will not exceed 3, and centhaquine administration may continue for up to two days after enrollment. Each patient will be closely monitored throughout their hospitalization and followed until discharge or up to seven days from enrollment, whichever comes first. The trial will assess safety and efficacy parameters according to a predefined schedule of visits. The baseline characteristics of the patients in different groups will be compared using statistical tests such as the Chi-square test for categorical variables and the Unpaired t-test for continuous variables. Changes in dichotomous variables between groups from baseline to follow-ups will be analyzed using McNemar's test. Survival rates will be measured using Kaplan-Meier survival analysis, and univariate and multiple Cox-regression analysis will be employed to determine hazard ratios and their 95% confidence intervals for patient survival. The trial results will be presented as mean±SEM (median, minimum, and maximum) values and percentages.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, multi-centric, open-labeled, single-arm and phase-IV study in 400 hypovolemic shock patients with a systolic arterial blood pressure ≤ 90 mmHg. The study duration will be approximately 15 months, including a 12-month enrollment period. All patients in the single group of the study will receive treatment with "Centhaquine (Dose: 0.01 mg/kg) + Standard of care." A second dose of centhaquine may be given if the systolic blood pressure remains low. However, the maximum number of doses per day should not exceed 3, and if needed the treatment will continue for the 2nd day of enrollment. Within the first 48 hours post-enrollment, a minimum of 1 dose and a maximum of 6 doses of centhaquine will be administered. Each patient will be closely monitored throughout their hospitalization and followed until discharge or day 7 (whichever comes earlier) from enrollment.
| Arm | Type | Receives |
|---|---|---|
| Centhaquine (Dose: 0.01 mg/kg) + Standard of care | Experimental | Drug: CenthaquineCenthaquine will be administered intravenously after enrollment to hypovolemic shock patients with systolic arterial blood pressure ≤ 90 mmHg at presentation and continue to receive standard shock treatment. Centhaquine will be administered at a dose of 0.01 mg/kg of body weight, as an intravenous (IV) infusion over 1 hour in 100 mL of normal saline. Second dose of centhaquine will be administered if SBP falls below or remains below or equal to 90 mmHg but not before 4 hours of the previous dose and total doses per day (in 24 hours) will not exceed 3 doses. Centhaquine administration if needed will continue for two days post-enrollment. A minimum of 1 dose or maximum of 6 doses of centhaquine will be administered within first 48 hours post-enrollment. Each patient will be monitored closely throughout his/her hospitalization and will be followed until discharge or day 7 (whichever is earlier) from enrollment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CenthaquineAlso: LYFAQUIN™, Centhaquine Citrate, 2-(2-(4-(3-methylphenyl)-1-piperazinyl)ethyl) quinoline citrate, PMZ-2010Centhaquine (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. | Drug | Centhaquine (Dose: 0.01 mg/kg) + Standard of care |
Primary outcome
Proportion of patients with adverse events (AEs) and serious adverse events (SAEs)
Time frame: Up to 7 days
Any unfavorable sign, symptom, or disease that occurs while using centhaquine will be reported as an adverse event (AE), including worsening of pre-existing medical conditions. A severe medical occurrence, such as death, life-threatening situations, hospitalization, significant disability, or congenital anomalies will be reported as a serious adverse event (SAE). AEs will be collected through patient questioning, spontaneous reports, and observation. Description, severity, start and end dates, incidence, relationship to the centhaquine, seriousness, action taken, and outcome of AEs will be documented in source documents and case report forms (CRFs). All SAEs will be reported within 24 hours to the sponsor, Drugs Controller General of India, and the ethics committee. Follow-up information and hospitalization or autopsy reports will be provided if necessary. A detailed analyzed report of all SAEs will be prepared and submitted to relevant authorities within 14 days.
10 secondary outcomes
Systolic and diastolic blood pressure
Time frame: Up to 7 days
Blood lactate
Time frame: 48 hours
Base-deficit
Time frame: 48 hours
Time in intensive care unit (ICU)
Time frame: Up to 7 days
Time on ventilator
Time frame: Up to 7 days
Urine output
Time frame: 48 hours
Incidence of mortality
Time frame: 7 days
Multiple Organ Dysfunction Syndrome score (MODS)
Time frame: Up to 7 days
Acute Respiratory Distress Syndrome (ARDS)
Time frame: Up to 7 days
Glasgow Coma Scale (GCS)
Time frame: Up to 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Background: PubMed 22964270Lavhale MS, Havalad S, Gulati A. Resuscitative effect of centhaquin after hemorrhagic shock in rats. J Surg Res. 2013 Jan;179(1):115-24. doi: 10.1016/j.jss.2012.08.042. Epub 2012 Sep 2.
- Background: PubMed 36726848Geevarghese M 3rd, Patel K, Gulati A, Ranjan AK. Role of adrenergic receptors in shock. Front Physiol. 2023 Jan 16;14:1094591. doi: 10.3389/fphys.2023.1094591. eCollection 2023.
- Background: PubMed 26216751Papapanagiotou P, Xanthos T, Gulati A, Chalkias A, Papalois A, Kontouli Z, Alegakis A, Iacovidou N. Centhaquin improves survival in a swine model of hemorrhagic shock. J Surg Res. 2016 Jan;200(1):227-35. doi: 10.1016/j.jss.2015.06.056. Epub 2015 Jun 29.
- Background: PubMed 22487389Gulati A, Lavhale MS, Garcia DJ, Havalad S. Centhaquin improves resuscitative effect of hypertonic saline in hemorrhaged rats. J Surg Res. 2012 Nov;178(1):415-23. doi: 10.1016/j.jss.2012.02.005. Epub 2012 Apr 2.
- Background: PubMed 23871440Gulati A, Zhang Z, Murphy A, Lavhale MS. Efficacy of centhaquin as a small volume resuscitative agent in severely hemorrhaged rats. Am J Emerg Med. 2013 Sep;31(9):1315-21. doi: 10.1016/j.ajem.2013.05.032. Epub 2013 Jul 19.
- Background: PubMed 30006694Kontouli Z, Staikou C, Iacovidou N, Mamais I, Kouskouni E, Papalois A, Papapanagiotou P, Gulati A, Chalkias A, Xanthos T. Resuscitation with centhaquin and 6% hydroxyethyl starch 130/0.4 improves survival in a swine model of hemorrhagic shock: a randomized experimental study. Eur J Trauma Emerg Surg. 2019 Dec;45(6):1077-1085. doi: 10.1007/s00068-018-0980-1. Epub 2018 Jul 13.
- Background: PubMed 34012389Ranjan AK, Zhang Z, Briyal S, Gulati A. Centhaquine Restores Renal Blood Flow and Protects Tissue Damage After Hemorrhagic Shock and Renal Ischemia. Front Pharmacol. 2021 May 3;12:616253. doi: 10.3389/fphar.2021.616253. eCollection 2021.
- Background: PubMed 33970455Gulati A, Jain D, Agrawal NR, Rahate P, Choudhuri R, Das S, Dhibar DP, Prabhu M, Haveri S, Agarwal R, Lavhale MS. Resuscitative Effect of Centhaquine (Lyfaquin(R)) in Hypovolemic Shock Patients: A Randomized, Multicentric, Controlled Trial. Adv Ther. 2021 Jun;38(6):3223-3265. doi: 10.1007/s12325-021-01760-4. Epub 2021 May 10.
- Background: PubMed 34061314Gulati A, Choudhuri R, Gupta A, Singh S, Ali SKN, Sidhu GK, Haque PD, Rahate P, Bothra AR, Singh GP, Maheshwari S, Jeswani D, Haveri S, Agarwal A, Agrawal NR. A Multicentric, Randomized, Controlled Phase III Study of Centhaquine (Lyfaquin(R)) as a Resuscitative Agent in Hypovolemic Shock Patients. Drugs. 2021 Jun;81(9):1079-1100. doi: 10.1007/s40265-021-01547-5. Epub 2021 Jun 1.
- Derived from this study: PubMed 38999331Khanna A, Vaidya K, Shah D, Ranjan AK, Gulati A. Centhaquine Increases Stroke Volume and Cardiac Output in Patients with Hypovolemic Shock. J Clin Med. 2024 Jun 27;13(13):3765. doi: 10.3390/jcm13133765.
- Individual participant dataSharing planned: No. Plan to publish the findings after completion of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Manish Lavhale, Ph.D. study director
Pharmazz India
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Centhaquine in people with Hypovolemic Shock, run by Pharmazz, Inc. at 17 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dharmesh Shah, Dr. (+91(120)256-9779, dharmesh.shah@pharmazz.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with adverse events (AEs) and serious adverse events (SAEs) (time frame: Up to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05956418, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.