| CTRI Number |
CTRI/2025/02/080173 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
02/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To see the effectiveness of N acetyl cysteine in lower the risk of organ failures and deaths in paraquat poisoining. |
|
Scientific Title of Study
|
Evaluating therapeutic efficacy of N acetylcysteine in reducing organ dysfunction and mortality in acute paraquat poisoning an open label, parallel-group randomised control trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Cheekatla Venkata Santosh |
| Designation |
Junior Resident |
| Affiliation |
Postgraduate Institute OF Medical Education and Research |
| Address |
Department Of Internal Medicine, Level 4, F Block, Nehru Hospital, Postgraduate Institute OF Medical Education and Research, Sector 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8333916852 |
| Fax |
|
| Email |
santoshcheekatla@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saurabh C Sharda |
| Designation |
Assistant Professor |
| Affiliation |
Postgraduate Institute Of Medical Education and Research, Chandigarh |
| Address |
Department Of Internal Medicine, Level 4, F Block, Nehru Hospital, Postgraduate Institute OF Medical Education and Research, Sector 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
01722756670 |
| Fax |
|
| Email |
saurabhcsharda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saurabh C Sharda |
| Designation |
Assistant Professor |
| Affiliation |
Postgraduate Institute OF Medical Education and Research |
| Address |
Department Of Internal Medicine, Level 4, F Block, Nehru Hospital, Postgraduate Institute OF Medical Education and Research, Sector 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
01722756670 |
| Fax |
|
| Email |
saurabhcsharda@gmail.com |
|
|
Source of Monetary or Material Support
|
| Special Research Thesis Grant, Department Of Internal Medicine, Level 4, F Block, Nehru Hospital, Postgraduate Institute OF Medical Education and Research, Sector 12, Chandigarh, India, 160012 |
|
|
Primary Sponsor
|
| Name |
Postgraduate Institute OF Medical Education and Research |
| Address |
Postgraduate Institute OF Medical Education and Research, Sector 12, Chandigarh, 160012, India |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Cheekatla Venkata Santosh |
Nehru Hospital, Postgraduate Institute of Medical Education and Research, Chandigarh |
Department Of Internal Medicine, Level 4, F Block, Postgraduate Institute OF Medical Education and Research, Sector 12
Chandigarh
CHANDIGARH |
8333916852
santoshcheekatla@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Postgraduate Institute of Medical Education and Research, Chandigarh Institutional Ethics Committee (Intramural) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T603||Toxic effect of herbicides and fungicides, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
N ACETYLCYSTEINE |
We plan to give intravenous N acetylcysteiene 150mg per kg in 500ml 5 percentage dextrose for 1 hour followed by 50mg per kg in 500 ml 5 percentage dextrose for 4 hours followed by 100mg per kg in 1000ml of 5 percentage dextrose for 16 hours in
patients aged more than 18 years with history of ingestion of paraquat till 5 days |
| Comparator Agent |
STANDARD OF CARE |
The comparator group wont receive intravenous N acetylcysteine. The comparator group receives standard treatment for paraquat poisoning including IV Fluids and symptomatic care and if required oxygen therapy and vasopressor support as indicated |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
patients aged morethan 18 years with history of ingestion (oral route) of paraquat till 5 days
|
|
| ExclusionCriteria |
| Details |
1)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. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| prevention acute respiratory distress syndrome and reducing its severity |
after 14 days, the patient will be assessed for the organ failure or at the patient death for mortality |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)reducing the incidence of acute kidney injury
2)reducing occurrence of acute liver injury
3)reducing mortality in 14 days |
14 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="52" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
20/02/2025 |
| Date of Study Completion (India) |
02/12/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
02/12/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - None of the above
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [santoshcheekatla@gmail.com].
- For how long will this data be available start date provided 01-01-2027 and end date provided 01-01-2038?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
Modification(s)
|
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. |