The aim of this study is evaluating the effect of Extract zataria on clinical outcomes in patients with permanent allergic rhinitis. In this study 43 patients with signs and symptoms of allergic rhinitis, approved by the allergist were involved in Phase III double-blinded clinical trial in level of patient, researcher and they were located in groups of Extract zataria and control. Participants completed SNOT-22
forms and treated with placebo and Extract zataria for two months. Primary and secondary consequences according to this questionnaire included sleep disorders, sneezing and nasal congestion
Inclusion criteria is affecting Verified allergic rhinitis and Exclusion criteria are taking other drugs with antioxidant or anti-inflammatory effect and any herbal medicine and pregnancy. Then, after the loss of patients during the study clinical and laboratory data processed in Two groups of fifteen (n = 30).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016121823235N6
Registration date:2017-03-28, 1396/01/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-03-28, 1396/01/08
Registrant information
Name
Farahzad Jabbari Azad
Name of organization / entity
Allergy Research Center, Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1801 2770
Email address
jabbarif@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2015-05-22, 1394/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial to evaluate the effect of Extract zataria multiflora on clinical sign in Prennial Allergic Rhinitis compared with placebo
Public title
Effect of Extract zataria multiflora on controlling the symptoms of Prennial Allergic Rhinitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:approved clinical perennial allergic rhinitis and laboratory diagnosis;the desire of patients to drug treatment and participation in the project
Exclusion criteria: The risk of other causes of rhinitis; affected of systemic diseases; take any other medicines with antioxidant properties; taking anti-inflammatory drug ; taking any herbal medicine; Thyme intolerance side effects (nausea, vomiting, diarrhea, etc.); Pregnancy and lactation
Age
From 15 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Ethics Committee of Mashahd University of Medical Sciencesپ
Street address
Daneshgah Street
City
Mashhad
Postal code
Approval date
2013-03-13, 1391/12/23
Ethics committee reference number
IR.MUMS.REC.1393.74
Health conditions studied
1
Description of health condition studied
Perennial allergic rhinitis
ICD-10 code
J30.3
ICD-10 code description
Other allergic rhinitis
Primary outcomes
1
Description
Clinical symptoms of allergic rhinitis
Timepoint
After two month
Method of measurement
questionnaire
Secondary outcomes
1
Description
Added at 2017-10-31: IL-4 & IL-5 & γINF
Timepoint
Added at 2017-10-31: After the intervention
Method of measurement
Added at 2017-10-31: Eliza
Intervention groups
1
Description
In Intervention group Thyme Syrup extract give three times a day 150 mg (10 cc) for two month with normal treatment of rhinits
Category
Treatment - Drugs
2
Description
In control group placebo give once a day for two month with normal treatment of rhinitis
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Allergy Clinic Ghaem Hospital
Full name of responsible person
Dr Farahzad Jabbari Azad
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Daneshgah Ave, Mashhad
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, 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
Mashad Universityof Medcal Sciences
Full name of responsible person
Maryam Paanahi
Position
General Medicine Students
Other areas of specialty/work
Street address
Allergy Reaserch Center, Ghaem Hospital, Ahmad Abad Street, Mashhad
City
Mashhad
Postal code
Phone
+98 518012770
Fax
Email
arc@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Allergy Research Center, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran
Full name of responsible person
Farahzad Jabbari Azad, MD
Position
Associate Professor
Other areas of specialty/work
Street address
Department of Immunology and Allergy, Hospital Ghaem, Ahmadabad streets, Mashhad
City
Mashhad
Postal code
Phone
+98 51 0801 2770
Fax
Email
jabbarif@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
Jalal Ghorbani
Position
MSc of Immunology
Other areas of specialty/work
Street address
City
Mashhad
Postal code
Phone
00
Fax
Email
GHORBANI.JALAL@YAHOO.COM
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)