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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01922700
Other study ID # PEPPER01
Secondary ID
Status Completed
Phase N/A
First received August 8, 2013
Last updated July 18, 2014
Start date April 2013
Est. completion date October 2013

Study information

Verified date July 2014
Source Sheri Kashmir Institute of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority India: SheriKashmir Institute of Medical Sciences
Study type Observational

Clinical Trial Summary

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.


Description:

Eligibility:

History of exposure to a pepper grenade explosion.

Exclusion:

Participation in combat operation/ stone pelting/ demonstration.


Recruitment information / eligibility

Status Completed
Enrollment 298
Est. completion date October 2013
Est. primary completion date September 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

All participants with a history of exposure to pepper gas grenade explosion

Exclusion Criteria:

Combatant role while exposure

Study Design

Observational Model: Ecologic or Community, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
India SheriKashmir Institute of Medical Sciences Srinagar Jammu & Kashmir

Sponsors (1)

Lead Sponsor Collaborator
Sheri Kashmir Institute of Medical Sciences

Country where clinical trial is conducted

India, 

References & Publications (3)

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. — View Citation

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. — View Citation

Vesaluoma M, Müller 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other 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 24 hours No
Primary 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. 24 hours No
Secondary Duration of symptoms developed 10 days No
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