Aims: assessment of Origanum Vulgaris L. Effect on Allergic Rhinitis Compared to Placebo.
Study design: the study is blocked randomized, placebo controlled, double blind, uni-center clinical trial.
Major inclusion criteria: men and women aged 18 to 60 years old; outpatients with a history or diagnosis of allergic rhinitis for at least 6 months before the first visit; allergic rhinitis and the numbers of eosinophil in the nasal mucous or the skin Prick test is proven (if not already done during the last 6 months); signing informed consent. Major exclusion criteria: patients taking drugs other than drugs that must consume according to the research plan, the duration of the project will be excluded from use; patients during the study have a fungal, viral or bacterial disease; patients who do not follow the recommended instructions.
Sample size: 110 persons.
Intervention duration: 14 months.
Primary outcome or studied outcomes: effect of Origanum Vulgaris L. Effect on Allergic Rhinitis Compared to Placebo.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016061416925N2
Registration date:2016-10-26, 1395/08/05
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-10-26, 1395/08/05
Registrant information
Name
Seyed Morteza Emami Alorizi
Name of organization / entity
Shiraz University of Medcal Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3230 5410
Email address
smemami@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2016-11-01, 1395/08/11
Expected recruitment end date
2017-03-01, 1395/12/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of Origanum Vulgaris L. Effect on Allergic Rhinitis Compared to Placebo: a randomized-controlled clinical trial.
Public title
Effect of Origanum Vulgaris L. on Allergic Rhinitis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: men and women aged 18 to 60 years old; outpatients with a history or diagnosis of allergic rhinitis for at least 6 months before the first visit; allergic rhinitis and the numbers of eosinophil in the nasal mucous or the skin Prick test is proven (if not already done during the last 6 months); signing informed consent; patients with a diagnosis of allergic rhinitis are previous topical or systemic treatments include antihistamines and corticosteroids have not responded or those with complications who have had previous with these drugs, do not want or cannot be treated with these drugs are; no anatomical abnormalities in the nose (nasal polyp or severe deviation); drugs that are used to treat allergies and if they use, it must be discontinued before the study; patients who are able to read and understand the consent form; ; patients who have not dementia; are not pregnant or are able to communicate and patients without nasopharyngeal tumors; patients who have not a history of drug allergy with Origanum vulgare.
Exclusion criteria: patients taking drugs other than drugs that must consume according to the research plan, the duration of the project will be excluded from use; patients during the study have a fungal, viral or bacterial disease; patients who do not follow the recommended instructions will be excluded.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
110
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
Shiraz University of Medcal Sciences
Street address
Shiraz University of Medcal Sciences(Central Building), Zand Ave.
City
Shiraz
Postal code
713451978
Approval date
2016-08-07, 1395/05/17
Ethics committee reference number
IR.SUMS.REC.1395.92
Health conditions studied
1
Description of health condition studied
Allergic Rhinitis
ICD-10 code
J30-J39
ICD-10 code description
Other diseases of upper respiratory tract
Primary outcomes
1
Description
The overall clinical symptoms.
Timepoint
Before the intervention and after intervention once a week, for a month.
Method of measurement
Rhinitis Quality of Life Questionnaire.
2
Description
Severity of rhinorrhea.
Timepoint
Before the intervention and after intervention once a week, for a month.
Method of measurement
Rhinitis Quality of Life Questionnaire.
3
Description
Severity of itchy nose.
Timepoint
Before the intervention and after intervention once a week, for a month.
Method of measurement
Rhinitis Quality of Life Questionnaire.
4
Description
Severity of nasal obstruction.
Timepoint
Before the intervention and after intervention once a week, for a month.
Method of measurement
Rhinitis Quality of Life Questionnaire.
5
Description
Frequency of sneezing per day.
Timepoint
Before the intervention and after intervention once a week, for a month.
Method of measurement
Rhinitis Quality of Life Questionnaire.
6
Description
Severity of itchy palate.
Timepoint
Before the intervention and after intervention once a week, for a month.
Method of measurement
Rhinitis Quality of Life Questionnaire.
7
Description
Severity of eye symptoms.
Timepoint
Before the intervention and after intervention once a week, for a month.
Method of measurement
Rhinitis Quality of Life Questionnaire.
8
Description
Number of nose palate eosinophils.
Timepoint
Before the intervention and after intervention once a week, for a month.
Method of measurement
Rhinitis Quality of Life Questionnaire.
Secondary outcomes
1
Description
Assessment of allergic rhinitis symptoms recovery based on the international diagnostic criteria of rhinitis quality of life questionnaire.
Timepoint
Before the intervention and after intervention once a week, for a month.
Method of measurement
Questionnaire.
Intervention groups
1
Description
Intervention group uses Origanum Vulgaris L. Extract; nasal spray, 40g/20ml, 2 puff, 3 times/day, for 1 month.
Category
Treatment - Drugs
2
Description
Control group uses placebo for 1 month.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Polyclinic
Full name of responsible person
Seyed Morteza Emami Alorizi
Street address
Namazi square, Zand Ave., Shiraz, Fars, Iran.
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Basir Hashemi
Street address
Shiraz University of Medical Sciences, Zand Ave., Shiraz, Fars, Iran.
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Morteza Emami Alorizi
Position
PhD of PersianTraditional Medicine/The second presenter.
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, Zand Ave., Shiraz, Fars, Iran.
City
Shiraz
Postal code
713451978
Phone
+98 71 3230 5410
Fax
Email
smemami@sums.ac.ir, morteza.emami@ymail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Allergy Research Center.
Full name of responsible person
Seyed Hesamedin Nabavizade
Position
Professor
Other areas of specialty/work
Street address
Namazi Hospital, Zand St, Shiraz, Iran.
City
Shiraz
Postal code
719335899
Phone
+98 71 3612 2267
Fax
+98 71 3628 1563
Email
drhesamnabavi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Morteza Emami Alorizi
Position
PhD of PersianTraditional Medicine/The second presenter.
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences(Central Building), Zand Ave., Shiraz, Fars, Iran.
City
Shiraz
Postal code
713451978
Phone
+98 71 3230 5410
Fax
Email
smemami@sums.ac.ir; morteza.emami@ymail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)