Determine the effect of mint nasal spray 1.5% and its control group in treatment of nasal polyp.
Design
In this research, 80 eligible patients referring to ENT clinic will be chosen purposefully and a code was allocated to each one of them. Then, patients were randomly divided into two control and intervention groups.
Settings and conduct
Eligible patients with nasal polyp referring to ENT clinic of buh ali and valiasr hospitals will be chosen purposefully .
Participants/Inclusion and exclusion criteria
inclusion criteria: Aged 18 to 65 years old, symptomatic nasal polyps; exclusion criteria: under the age of 18 and over 65, pregnant and lactating women, asymptomatic polyps, antrocoanal polyps, asthmatic patients, aspirin sensitivity, cystic fibrosis.
Intervention groups
Intervention group: mint nasal spray 1.5% 2 puffs every 12 hours in each nostril for 4 weeks and tablet cetirizine 10 mg daily.
Control group: Nasal spray of placebo 2 puffs every 12 hours in each nostril for 4 weeks and tablet cetirizine 10 mg daily.
Main outcome variables
The size of the nasal polyp by rhinoscopic examination and endoscopy before the intervention, 2 weeks after the intervention and immediately after it.
Evaluation of quality of life and severity of symptoms by standard snot-22 questionnaire before intervention, 2 weeks after intervention and immediately after it.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160821029460N2
Registration date:2018-02-13, 1396/11/24
Registration timing:retrospective
Last update:2018-02-13, 1396/11/24
Update count:0
Registration date
2018-02-13, 1396/11/24
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3337 9054
Email address
bparvin@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2017-12-22, 1396/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the efficacy of the mint nasal spray 1.5% in treatment of nasal polyp.
Public title
the efficacy of the mint nasal spray 1.5% in treatment of nasal polyp.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients aged 18 to 65 years old.
having one of this symptoms: nasal obstruction, post nasal discharge, loss of smell, facial pain/pressure, runny nose, need to blow nose
Diagnosis of nasal polyps with rhinoscopic examination and endoscopy
Exclusion criteria:
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
block randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
blinding of Participant and outcome evaluator including the researcher
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Imam Sq, Joybar 3way, Start of Valiasr Highway, Mazandaran University of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
4815733971
Approval date
2016-05-08, 1395/02/19
Ethics committee reference number
IR.MAZUMS.REC.95.1990
Health conditions studied
1
Description of health condition studied
Nasal polyp
ICD-10 code
J33.8
ICD-10 code description
Other polyp of sinus. Polyp of sinus: accessory ,ethmoidal ,maxillary ,sphenoidal
Primary outcomes
1
Description
The size of the nasal polyp
Timepoint
before the intervention, 2 weeks after the intervention and immediately after it
Method of measurement
rhinoscopic examination and endoscopy
2
Description
Evaluation of quality of life and severity of symptoms
Timepoint
before the intervention, 2 weeks after the intervention and immediately after it
Method of measurement
standard snot-22 questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: mint nasal spray 1.5% 2 puffs every 12 hours in each nostril and tablet cetirizine 10 mg daily for 4 weeks .
Category
Treatment - Drugs
2
Description
Control group: Nasal spray of placebo 2 puffs every 12 hours in each nostril and tablet cetirizine 10 mg daily for 4 weeks .
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
ENT Clinic of Buhali (Sari) and Valiasr (Qaemshahr) hospitals
Full name of responsible person
Bahareh Parvin
Street address
Pasdaran Blvd (Sari), Sari Ave (Qaemshahr)
City
Sari and Qaemshahr
Province
Mazandaran
Postal code
.
Phone
+98 11 3333 4301
Email
bparvin@mazums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Majid Saeedi
Street address
Imam Sq, Joybar 3way, Start of Valiasr Highway, Mazandaran University of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3325 7230
Email
bparvin@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Bahareh Parvin
Position
Ph.D Student of Iranian Traditional Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Khazar Blvd, Faculty of persian Medicine
City
Sari
Province
Mazandaran
Postal code
4816895475
Phone
+98 11 3324 4893
Email
bparvin@mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Mohammad Yousofpoor
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Khazar Blvd, Faculty of Persian Medicine
City
Sari
Province
Mazandaran
Postal code
4816895475
Phone
+98 11 3324 4893
Email
m.yousofpoor@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Bahareh Parvin
Position
Ph.D student of Iranian Traditional medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Khazar Blvd, Faculty of Persian Medicine
City
Sari
Province
Mazandaran
Postal code
4816895475
Phone
+98 11 3324 4894
Email
bparvin@mazums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available