Home » Trials » SLCTR/2008/016

Efficacy of antioxidant therapy in acute paraquat poisoning


SLCTR Registration Number


Date of Registration

22 Aug 2008

The date of last modification

Mar 03, 2019

Trial Status

Application Summary

Scientific Title of Trial

Efficacy of antioxidant therapy in acute paraquat poisoning

Public Title of Trial

Improvement following acute paraquat poisoning due to antioxidant therapy

Disease or Health Condition(s) Studied

Acute paraquat intoxication

Scientific Acronym


Public Acronym


Brief title

Antioxidant trial

Universal Trial Number


Any other number(s) assigned to the trial and issuing authority


Trial Details

What is the research question being addressed?

Would antioxidants (intravenous vitamin C or intravenous vitamin C to paraquat?

Type of study


Study design


Randomized controlled trial


Double blinded


Standard therapy/practice





Study Phase

Not Available

Intervention(s) planned

Apart from the standard management (Fernando, 1998), patients will be given intra venous vitamin C as follow, 100 mg, 500 mg, 1000 mg, 3000 mg/day and 3000 mg/ 8 h for 5 consecutive days. S. Y. Hong et al (2002) stated that white blood cell count (WBC), serum Aspartate amino transferase (GOT) and arterial blood PaO2 were significantly decrease (from 9* 103 ± 564 mm3 to 8.5* 103 ± 347 mm3; p<0.05, from 27.0 ± 3.8 IU to 22.0 ± 2.7 IU; p<0.01 and from 99.5 ± 3.4 mmHg to 87.3 ± 7.1 mmHg ; p<0.001 respectively) during the observation period after administration of Intravenous vitamin C. They also noted that when the amount of vitamin C increased to 3000 mg, patients complained pain around the injection site(Hong et al., 2002). Therefore after each dose pulse rate, blood pressure, respiratory rate, body temperature will be monitored every 6 hours and white blood cell count (WBC), liver and renal function tests, urine analysis and oxygen saturation will be conducted every day. In the treatment of paracetamol poisoning N-acetylcysteine (NAC) is given in an initial dose of 150 mg/kg in 200 ml 5% dextrose over 15 minutes followed by 50 mg/kg in 500 ml 5% dextrose over four hours and 100 mg/kg in one litre 5% dextrose over the next 16 hours (total dose 300 mg/kg in 20 hours) (Fernando, 1998; L F Prescott, 1979) But rashes and anaphylaxis are known adverse effects of N-acetylcysteine with the dose given in paracetamol poisoning. Therefore I would like to propose a regimen for NAC which can be used in paraquat intoxication. Proposed NAC regimen for paraquat intoxication will be as follow; Initially 20 mg/kg in 200mL of 5% dextrose over 15 minutes Followed by 50 mg/kg in 500mL over 12 hours (? 4 mg/h/kg) twice per day for 3 days The total dose will be 320 mg/kg in 72 hours

Inclusion criteria

Consecutive patients who get admitted to General Hospital, Matara following history of acute exposure to paraquat and symptoms suggestive of acute exposure to paraquat will be selected for the study

Exclusion criteria

• Unconscious patients • Pregnant mothers

Primary outcome(s)


Improvement of total antioxidant status in plasma after administration of Intra Venous vitamin C+placebo or vitamin C + NAC


First five consecutive days of acute exposure to paraquat


Secondary outcome(s)


Improvement of survival


Two months after acute exposure to paraquat


Target number/sample size


Countries of recruitment

Sri Lanka

Anticipated start date


Anticipated end date


Date of first enrollment

Date of study completion

Recruitment status

Complete: follow up complete

Funding source

South Asian Clinical Toxicology Research Collaboration

Regulatory approvals

State of Ethics Review Approval



Date of Approval


Approval number

Not Available

Details of Ethics Review Committee

Name: Ethics Review Committee, Faculty of Medicine, University of Ruhuna
Institutional Address:PO Box 70, Labuduwa Rd, Galle, Sri Lanka
Telephone:+94-91-2234801/803 (Extension: 161)
Email: ethics@med.ruh.ac.lk

Contact & Sponsor Information

Contact person for Scientific Queries/Principal Investigator

Dr Sudheera Jayasinghe
Probationary Lecturer
Faculty of Medicine, University of Ruhuna
+94 91 2246877

+94 91 2222314

Contact Person for Public Queries

Dr Sudheera Jayasinghe
Probationary Lecturer
Faculty of Medicine, University of Ruhuna
+94 91 2246877

+94 91 2222314

Primary study sponsor/organization

South Asian Clinical Toxicology Research Collaboration

Faculty of Medicine, University of Peradeniya, Sri Lanka
+94 81 2384556


Secondary study sponsor (If any)


Trial Completion details

Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

IPD sharing plan description

Not Available

Study protocol available

Protocol version and date

Not Available

Protocol URL

Not Available

Results summary available


Date of posting results

Date of study completion

Final sample size

Date of first publication

Link to results

Brief summary of results