NCT01922700

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
298

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 14, 2013

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

July 21, 2014

Status Verified

July 1, 2014

Enrollment Period

5 months

First QC Date

August 8, 2013

Last Update Submit

July 18, 2014

Conditions

Keywords

Pepper spraybronchospasmlacrimation

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Duration of symptoms developed

    10 days

Other Outcomes (1)

  • 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

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Community based non-combatant individuals exposed to pepper gases while being used on combatants.

You may qualify if:

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

You may not qualify if:

  • Combatant role while exposure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SheriKashmir Institute of Medical Sciences

Srinagar, Jammu and Kashmir, 190011, India

Location

Related 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.

    PMID: 22582490BACKGROUND
  • 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.

MeSH Terms

Conditions

CoughLacerationsBronchial Spasm

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsWounds and InjuriesBronchial Diseases

Study Officials

  • Parvaiz Koul, MD, FRCP, FACP

    Professor & Head, Internal & Pulmonary Medicine, SKIMS,Srinagar 190011 , J&K (India)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor & Head, Internal & Pulmonary Medicine

Study Record Dates

First Submitted

August 8, 2013

First Posted

August 14, 2013

Study Start

April 1, 2013

Primary Completion

September 1, 2013

Study Completion

October 1, 2013

Last Updated

July 21, 2014

Record last verified: 2014-07

Locations