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Assessment of the effect of Zofa (Nepeta bracteata Benth) Syrup on allergic rhinitis symptoms

Protocol summary

Summary
This is a double blind study, for Assessing the effect of Zofa (Hyssop)syrup and placebo on the treatment of allergic rhinitis. Qualified patients that fulfilled for inclusion criteria such as aged 18-65, not administered usual medicine in last two weeks, not lactation and pregnant, not having excluded criteria are entered and the patients with severe nose septal deviation, recent trauma to nose, lactating, pregnant females are excluded.The patients affected with allergic rhinitis were conducted to the study. The sample size in each group is 33 (case and control)The dose of zofa (Nepeta) syrup and placebo syrup is three times per day and each time 10cc. The patients diagnosed , confirmed by history and clinical examination and referred for allergic rhinitis disease by ENT specialist . The patients are randomly divided to two groups of placebo and intervention. Before entering in to study the required information is taken by the project agent, after receiving a written signed consent form and demographic questionnaire, standard questionnaire of ARIA, valid and reliable Persian questionnaire of allergic rhinitis are filled before and four weeks after prevention, the symptoms include : Sneezing, nasal obstruction, rhinorrhea, nose itching, eye symptoms (Redness, itching, watery), VAS (Visual analogue scale) are checked, then follow the necessary matters. At the end of the relevant information is extracted and analysed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013122615943N1
Registration date: 2015-02-04, 1393/11/15
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-02-04, 1393/11/15
Registrant information
Name
Mohammad reza haji heydari
Name of organization / entity
Shahed university
Country
Iran (Islamic Republic of)
Phone
+98 31 3364 1107
Email address
m.hajiheydari@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahed University of Medical Sciences
Expected recruitment start date
2014-12-01, 1393/09/10
Expected recruitment end date
2016-01-20, 1394/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effect of Zofa (Nepeta bracteata Benth) Syrup on allergic rhinitis symptoms
Public title
The effect of Zofa (Nepeta bracteata Benth) syrup on the allergic rhinitis disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Male and female patients aged 18 to 65 years with symptoms of allergic rhinitis; not taking of medicine commonly used allergic rhinitis for at least two weeks prior to admission; having of seasonal allergic rhinitis and perennial (intermittent and continuous); having criteria for allergic rhinitis based on the ARIA questionnaire; affected to mild allergic rhinitis. Exclusion criteria: Chronic diseases such as asthma, cancer; taking any medication known to affect chemical and herbal on allergic rhinitis; recent trauma to the nose; recent surgery of the nose; people exposed to irritants; pregnancy and lactation; the risk of epilepsy; vasomotor rhinitis; alpha-blocker drugs administration; the symptoms of acute sinusitis; taking systemic immunosuppressive therapy.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 66
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
Shahed University ethics committee
Street address
Shahed University, apposite to Imam Khomeini Holly Shrine, Khalij Fars free way
City
Tehran
Postal code
Approval date
2014-11-22, 1393/09/01
Ethics committee reference number
41/215591

Health conditions studied

1

Description of health condition studied
Allergic rhinitis
ICD-10 code
J30.2
ICD-10 code description
Other seasonal allergic rhinitis

2

Description of health condition studied
Other allergic rhinitis
ICD-10 code
J30.3
ICD-10 code description
Other allergic rhinitis

Primary outcomes

1

Description
Sneezing
Timepoint
Before and four weeks after intervention
Method of measurement
ARIA Questionnaire And VAS

2

Description
Nasal obstruction
Timepoint
Before and four weeks after intervention
Method of measurement
ARIA Questionnaire And VAS

3

Description
Rhinorrhea
Timepoint
Before and four weeks after intervention
Method of measurement
ARIA Questionnaire And VAS

4

Description
Watery ,itchy ,red eyes
Timepoint
Before and four weeks after intervention
Method of measurement
ARIA Questionnaire And VAS

5

Description
Itchy nose
Timepoint
Before and four weeks after intervention
Method of measurement
ARIA Questionnaire And VAS

Secondary outcomes

empty

Intervention groups

1

Description
Zofa (Hyssop ) syrup, three times a day, each time 10 cc for four weeks
Category
Treatment - Drugs

2

Description
Placebo syrup, three times a day each time 10 cc for four weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Mostafa Khomeini hospital
Full name of responsible person
Mohammad Ebrahim Yarmohammadi, MD
Street address
Italia street
City
Tehran

2

Recruitment center
Name of recruitment center
Iranian traditional medicine clinic of Shahed university
Full name of responsible person
Mohammad Reza Haji heydari
Street address
Beside of Arman dead lock ,third Dashtestan alley, Shariati street
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
shahed University of Medical Sciences
Full name of responsible person
Mohsen Naseri.MD
Street address
Traditional Medicine Clinical Trial Research Center؛ No.1471 ؛ Between Forsat and Nosrat Ave؛ North Kargar Ave؛ Enghelab Ave.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
shahed 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
Shahed University of Medical Sciences
Full name of responsible person
Mohammad Reza Haji heydari
Position
Resident ph.D of Iranian Traditional Medicine
Other areas of specialty/work
Street address
Iranian Traditional Medicine clinic of Shahed university, beside Arman alley, third Dashtestan, Shariati Ave
City
Tehran
Postal code
Phone
+98 21 2288 2521
Fax
Email
drmhajiheydari@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahed University of Medical Sciences
Full name of responsible person
Mohammad Ebrahim Yarmohammadi. MD
Position
ENT Specialist
Other areas of specialty/work
Street address
Mostafa Khomeini hospital, Italia street,
City
Tehran
Postal code
Phone
+98 21 5121 4055
Fax
meyarmohammadi@yahoo.com
Email
meyarmohammadi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahed University of Medical Sciences
Full name of responsible person
Mohammad Reza Hajiheydari
Position
Resident ph.D of Iranian Traditional Medicine
Other areas of specialty/work
Street address
Tim Health care؛ Third Dashtestan Alley؛ Shariati Ave.
City
Tehran
Postal code
Phone
00
Fax
Email
Drmhajiheydari@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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