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Clinical Trials/CTRI/2025/02/080173
CTRI/2025/02/080173CompletedPhase 2

Evaluating therapeutic efficacy of N acetylcysteine in reducing organ dysfunction and mortality in acute paraquat poisoning an open label, parallel-group randomised control trial

Postgraduate Institute OF Medical Education and Research1 site in 1 country30 target enrollmentStarted: February 20, 2025Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
30
Locations
1
Primary Endpoint
prevention acute respiratory distress syndrome and reducing its severity
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

THIS IS AN OPEN LABEL PARALLEL GROUP, RANDOMISED CONTROL TRIAL TO BE CONDUCTED IN INDIA’S TERTIARY CARE CENTRE PGIMER CHANDIGARH. THIS STUDY EVALUATES THERAPEUTIC EFFICACY OF N ACETYLCYSTEINE IN REDUCING ORGAN DYSFUNCTION AND MORTALITY IN ACUTE PARAQUAT POISONING.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 99.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •patients aged morethan 18 years with history of ingestion (oral route) of paraquat till 5 days.

Exclusion Criteria

  • •only inhalational and dermal exposure to paraquat 2)pregnant females 3)chronic lung disease (COPD&ILD) 4)chronic kidney disease 5) COVID-19-Positive patients 6)paracetamol poisoning where N acetylcysteine is to be given as treatment 7)multiple poisonous compounds consumption like organophosphorus and paraquat poisoning.

Outcomes

Primary Outcomes

prevention acute respiratory distress syndrome and reducing its severity

Time Frame: after 14 days, the patient will be assessed for the organ failure or at the patient death for mortality

Secondary Outcomes

  • 1)reducing the incidence of acute kidney injury(2)reducing occurrence of acute liver injury)

Investigators

Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Cheekatla Venkata Santosh

Postgraduate Institute OF Medical Education and Research

Study Sites (1)

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