The effect of aqueous-alcoholic extracts of Zataria multiflora and carvacerol on respiratory symptoms, pulmonary function tests and serum inflammatory mediators in chemical war victims
Aims: Evaluations of respiratory symptoms, chest wheezing, pulmonary function test and serum inflammatory mediators level will measure at baseline, one month and 2 months after treatment.
Design of study: In this study 80 patients with pulmonary complication due to sulfur mustard (SM) will randomly divided to four groups including: 1, treated with aqueous-alcoholic extracts 1.5 mg/kg, group 2 treated with aqueous-alcoholic extracts 3 mg/kg, group 3 treated with carvacrol 0.42 mg/kg and group 4 treated with placebo.
Methods: All drugs will prescript three times daily (5ml) as syrup for 2 months.
Inclusion criteria: The pationts expoused to sulfur mustard.
Exclusion criteria: The pationts should not have any cardiovascolar disorders
Respiratory symptoms and pulmonary function test (Primary outcome) serum inflammatory mediators level (Secondary outcome) will be measured as baseline, one month and 2 months after treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014031617020N1
Registration date:2016-03-04, 1394/12/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-03-04, 1394/12/14
Registrant information
Name
Mohammad Reza Khazdair
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3882 8888
Email address
khazdirmr921@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Pharmaceutical researsh center
Expected recruitment start date
2015-07-29, 1394/05/07
Expected recruitment end date
2016-10-31, 1395/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of aqueous-alcoholic extracts of Zataria multiflora and carvacerol on respiratory symptoms, pulmonary function tests and serum inflammatory mediators in chemical war victims
Public title
Effect of (aqueous-alcoholic) extracts of Zataria multiflora and carvacerol on symptoms,and respiratory function on chemical war victims
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: The pationts expoused to sulfur mustard.
Exclusion criteria: The pationts should not have any cardiovascolar disorders
Age
From 45 years old to 80 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
Vice chansellor of Research, Ghorshi Bilding, Daneshgah street, Mashhad, Iran
City
Mashhad
Postal code
Approval date
2014-07-12, 1393/04/21
Ethics committee reference number
920537
Health conditions studied
1
Description of health condition studied
Chemical war victims with respiratory symptoms
ICD-10 code
J68.4
ICD-10 code description
Chronic respiratory conditions due to chemicals, gases, fumes and vapours
Primary outcomes
1
Description
Respiratory symptoms
Timepoint
Baseline, one month and 2 months after treatment
Method of measurement
Check list and examination
2
Description
Pulmonary function test
Timepoint
Baseline, one month and 2 months after treatment
Method of measurement
Spirometry
Secondary outcomes
1
Description
Serum inflammatory mediators level
Timepoint
Baseline, one month and 2 months after treatment.
Method of measurement
By elisa kits
Intervention groups
1
Description
Group 3: Patients treated with carvacrol 0.42 mg/kg three time daily for 2 months
Category
Treatment - Drugs
2
Description
Group 4: Patients treated with placebo three time daily for 2 months
Category
Treatment - Drugs
3
Description
Group 1: Patients treated with aqueous-alcoholic extracts 1.5 mg/kg three time daily for 2 months
Category
Treatment - Drugs
4
Description
Group 2: Patients treated with aqueous-alcoholic extracts 3 mg/kg three time daily for 2 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic, Imam Reza Hospital, Department of Physiology and toxicology research center
Full name of responsible person
Mohammad Hossein Boskabady
Street address
Department of Physiology, Medical School, MUMS, Mashhad 9177948564, IR Iran
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of medical Sciences
Full name of responsible person
Mohammad Hossein Boskabady
Street address
Department of Physiology, Medical School, MUMS, Mashhad 9177948564, IR Iran
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Reza Khazdair
Position
PhD student
Other areas of specialty/work
Street address
Azadi Square- Campus of University, School of Medicine
City
Mashhad
Postal code
Phone
+51 38002216
Fax
Email
Khazdeirmr921@mums.ac.ir; M.khazdair@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Hossein Boskabady
Position
PhD
Other areas of specialty/work
Street address
Department of Physiology, Medical School, Mashhad University of Medical Sciences, Mashhad 9177948564, IR Iran
City
Mashhad
Postal code
9177948564
Phone
+51 38002228
Fax
Email
boskabadymh@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Reza Khazdair
Position
PhD student
Other areas of specialty/work
Street address
Department of Physiology, Medical School, Mashhad University of Medical Science, Mashhad
City
Mashhad
Postal code
Phone
+51 38002216
Fax
Email
Khazdeirmr921@mums.ac.ir; M.khazdair@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)