- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01922700
Effects of Pepper Gas Exposure in Non-combatant Bystanders.
July 18, 2014 updated by: Parvaiz A Koul, Sheri Kashmir Institute of Medical Sciences
Pepper Gas Exposure Study
Pepper sprays and pepper gas grenades are used by riot police at various places in the world for crowd control.
Data about the acute effects based on human studies is extremely scarce.
Kashmir valley in the northern Indian state of Jammu & Kashmir has witnessed political turmoil for the past 22 years and incidents of stone pelting are common wherein groups of youth indulge in stone pelting at the security personnel.
While there have been previous episodes of fatalities associated with incidents of firing by the security personnel; non lethal methods are adopted routinely now.
These include lathis, water cannons, tear gas and more recently the pepper gas grenades.
The pepper grenades explode in the area and the adverse effects are perceived by the population in the area too who are even sitting in their homes.
The study proposes to observe the health effects of the pepper gas exposure in non-combatant civilians.
Study Overview
Status
Completed
Conditions
Detailed Description
Eligibility:
History of exposure to a pepper grenade explosion.
Exclusion:
Participation in combat operation/ stone pelting/ demonstration.
Study Type
Observational
Enrollment (Actual)
298
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jammu & Kashmir
-
Srinagar, Jammu & Kashmir, India, 190011
- SheriKashmir Institute of Medical Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Community based non-combatant individuals exposed to pepper gases while being used on combatants.
Description
Inclusion Criteria:
All participants with a history of exposure to pepper gas grenade explosion
Exclusion Criteria:
Combatant role while exposure
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Development of cough, irritation in throat, nasal irritation, nasal discharge, wheezing, breathlessness, hemoptysis, chest pain upon exposure or worsening of already existing cough, breathlessness, wheezing of a previous respiratory illness.
Time Frame: 24 hours
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Duration of symptoms developed
Time Frame: 10 days
|
10 days
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Development of other non-respiratory symptoms which include (but not limited to) skin irritation, skin rash, lacrimation, visual disturbances, vomiting, any other GI symptom, headache, fever, seizures or any other neurological symptom and their duration
Time Frame: 24 hours
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Parvaiz Koul, MD, FRCP, FACP, Professor & Head, Internal & Pulmonary Medicine, SKIMS,Srinagar 190011 , J&K (India)
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Cil H, Atilgan ZA, Islamoglu Y, Tekbas EO, Dostbil Z. Is the pepper spray a triggering factor in myocardial infarction? A case report. Eur Rev Med Pharmacol Sci. 2012 Mar;16 Suppl 1:73-4.
- Holopainen JM, Moilanen JA, Hack T, Tervo TM. Toxic carriers in pepper sprays may cause corneal erosion. Toxicol Appl Pharmacol. 2003 Feb 1;186(3):155-62. doi: 10.1016/s0041-008x(02)00015-7.
- Vesaluoma M, Muller L, Gallar J, Lambiase A, Moilanen J, Hack T, Belmonte C, Tervo T. Effects of oleoresin capsicum pepper spray on human corneal morphology and sensitivity. Invest Ophthalmol Vis Sci. 2000 Jul;41(8):2138-47.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2013
Primary Completion (Actual)
September 1, 2013
Study Completion (Actual)
October 1, 2013
Study Registration Dates
First Submitted
August 8, 2013
First Submitted That Met QC Criteria
August 12, 2013
First Posted (Estimate)
August 14, 2013
Study Record Updates
Last Update Posted (Estimate)
July 21, 2014
Last Update Submitted That Met QC Criteria
July 18, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PEPPER01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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