Purpose: Effect of Extract of Urtica dioica on perennial Allergic Rhinitis, Design and criteria: This study is prospective, Randomized, double blinded and clinical trial. (Drug distributors and patients are blind about the type of drug). 20 Patients with symptoms of allergic rhinitis, referred to Immunology and ENT clinic were chosen and divided randomly into two group. The first group were treated with urtica dioica (150 mg qid for one month)
and the second group were treated with placebo for one month. Before and after treatment IL 5, IL4 and INF-gamma are compared. Inclusion criteria:
Clinical and laboratory diagnosis perennial allergic rhinitis; Patients' willingness to participate in treatment and plan
Exclusion criteria:
The risk of other causes of rhinitis; Systemic diseases such as polycythemia; Use of other drugs with anti-inflammatory properties;Use of any herbal remedy; Intolerance of side effects urtica dioica; Drug use weak immune system; Use of antidiabetic drugs; Use of hypertensive drugs; Pregnancy & Breastfeeding; Age less than 15 years and more than 45 years. Primary outcome: Diagnostic symptoms of Allergic rhinitis. Secondary outcome:Blood level of IgE, Blood level of IL5, Blood level of IL4, Blood level of INF Gamma, Nasal eosinophil count. Intervention group: The patients were treated with urtica dioica (150 mg qid for one month. Control group:The patients were treated with placebo for one month.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013102715177N1
Registration date:2013-11-19, 1392/08/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-11-19, 1392/08/28
Registrant information
Name
Mehdi Bakhshaee
Name of organization / entity
Mashhad University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 51 1859 4082
Email address
bakhshaeem@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Mashhad University of Medical Science
Expected recruitment start date
2013-05-10, 1392/02/20
Expected recruitment end date
2013-10-02, 1392/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Extract of Urtica dioica on perennial Allergic Rhinitis
Public title
Effect of Extract of Urtica dioica on perennial Allergic Rhinitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Clinical and laboratory diagnosis perennial allergic rhinitis; Patients' willingness to participate in treatment and plan
Exclusion criteria:
The risk of other causes of rhinitis; Systemic diseases such as polycythemia; Use of other drugs with anti-inflammatory properties;Use of any herbal remedy; Intolerance of side effects urtica dioica; Drug use weak immune system; Use of antidiabetic drugs; Use of hypertensive drugs; Pregnancy & Breastfeeding; Age less than 15 years and more than 45 years.
Age
From 15 years old to 45 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
20
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 Mashhad University of Medical Sciences
Street address
Mashhad University of Medical Sciences, Ghoreishi apartment, Daneshgah st, Mashhad
City
Mashhad
Postal code
Approval date
2013-05-04, 1392/02/14
Ethics committee reference number
910557
Health conditions studied
1
Description of health condition studied
Allergic Rhinitis
ICD-10 code
J30.3
ICD-10 code description
Other allergic rhinitis
Primary outcomes
1
Description
Symptoms of Allergic rhinitis
Timepoint
Befor and after treatment
Method of measurement
SNOT - 22
Secondary outcomes
1
Description
Blood level of IgE
Timepoint
Before and after treatment
Method of measurement
ELISA
2
Description
Blood level of IL5
Timepoint
Before and after treatment
Method of measurement
ELISA
3
Description
Blood level of IL4
Timepoint
Before and after treatment
Method of measurement
ELISA
4
Description
Blood level of INF Gamma
Timepoint
Before and after treatment
Method of measurement
ELISA
5
Description
Nasal eosinophil count
Timepoint
Before and after treatment
Method of measurement
Eosinophil count
Intervention groups
1
Description
Intervention group: The patients were treated with urtica dioica (150 mg qid for one month
Category
Treatment - Drugs
2
Description
Control group:The patients were treated with placebo for one month.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Street address
City
Mashhad
2
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Street address
City
Mashhad
3
Recruitment center
Name of recruitment center
Faculty of Pharmacy
Full name of responsible person
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Mashhad University of Medical Science
Full name of responsible person
Mohsen Tafaghodi
Street address
Ghoreishi building, Daneshgah street, 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 Science
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 Science
Full name of responsible person
Mehdi Bakhshaee
Position
Associate Professor
Other areas of specialty/work
Street address
Department of ENT, Imam Reza Hospital, Ibne Sina st, Mashhad
City
Mashhad
Postal code
Phone
+98 51 1859 4082
Fax
Email
Bakhshaeem@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad university of Medical Science
Full name of responsible person
Mehdi Bakhshaee
Position
Associate Professor
Other areas of specialty/work
Street address
Department of ENT, Imam Reza Hospital, Ibne Sina str, Mashhad
City
Mashhad
Postal code
Phone
+98 51 1859 4082
Fax
Email
Bakhshaeem@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad university of Medical Science
Full name of responsible person
Mehdi Bakhshaee
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)