Clinical trial NCT01922700: Effects of Pepper Gas Exposure in Non-combatant Bystanders.
Official title: Pepper Gas Exposure Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cough
Irritation in Throat
Irritation in Skin
Lacrimation
Keywords: Pepper spray
bronchospasm
lacrimation
Lead sponsor: Sheri Kashmir Institute of Medical Sciences
Sponsor class: OTHER
First posted: 2013-08-14
Enrollment: 298
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community based non-combatant individuals exposed to pepper gases while being used on combatants.

Brief 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.

Detailed description: Eligibility:

History of exposure to a pepper grenade explosion.

Exclusion:

Participation in combat operation/ stone pelting/ demonstration.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

Combatant role while exposure

Primary outcomes:
measure: 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.
timeFrame: 24 hours
Secondary outcomes:
measure: Duration of symptoms developed
timeFrame: 10 days
Other outcomes:
measure: 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
timeFrame: 24 hours
Locations:
city: Srinagar
country: India
facility: SheriKashmir Institute of Medical Sciences
state: Jammu & Kashmir
Study officials:
affiliation: Professor & Head, Internal & Pulmonary Medicine, SKIMS,Srinagar 190011 , J&K (India)
name: Parvaiz Koul, MD, FRCP, FACP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1016/s0041-008x(02)00015-7.
citation: 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.