Protocol summary

Summary
This study is designed to assess the effects of ketotifen fumarate drop and compares it with Ketotifen pill within 4-weeks after intervention. One hundred and fifty mild allergic rhinitis patients, referred to Baqiyatallah University of Medical Sciences Allergy Clinic will be enrolled to the study. Allergic rhinitis approves by clinical examination, history, and diagnostic tests. Patients consuming antihistamines and corticosteroids, refractory to antihistamines and leukotriene receptor antagonists, patients with asthma, acute and chronic rhino-sinusitis, polyposis, consuming tricyclic antidepressants and allergy to ketotifen will be excluded. Patients will be randomized to ketotifen fumarate 0.025% drop (one drop in each side of nose every 12 hours) with placebo pills (every 12 hours) and Placebo drop (one drop every 12 hours), with ketotifen pills (1 mg every 12 hours) groups. Patients will be evaluated by endoscopy, symptoms (sneezing, runny nose, itching, and nasal obstruction) severity score (0-10 VAS score), quality of life, and eosinophil percent for nasal smears, within 4-weeks treatment in 3 visits. Collected data will be compared in two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014051617413N3
Registration date: 2014-08-21, 1393/05/30
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-08-21, 1393/05/30
Registrant information
Name
Hamidreza Karimi-Sari
Name of organization / entity
Student Research Committee, Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8126 4354
Email address
hrkarimisari@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Baqiyatallah University of Medical Sciences, Deputy of Research
Expected recruitment start date
2014-04-21, 1393/02/01
Expected recruitment end date
2014-08-16, 1393/05/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Ketotifen Fumarate Drop and Ketotifen Pill on Symptom Severity, Quality of Life and Nasal Smear Eosinophil Percent in Allergic Rhinitis Patients: a Randomized Clinical Trial
Public title
Comparison Therapeutic Effects of Ketotifen Fumarate Drop and Ketotifen Pill in Patients with Allergic Rhinitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Mild allergic rhinitis patients referred to Baqiyatallah University of Medical Sciences Allergy Clinic without any age and gender limitations. Exclusion criteria: Patients consuming antihistamines and corticosteroids; refractory to antihistamines and leukotriene receptor antagonists; patients with asthma; acute and chronic rhino-sinusitis; polyposis; consuming tricyclic antidepressants; allergy to ketotifen
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 140
Randomization (investigator's opinion)
N/A
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
Baqiyatallah University of Medical Sciences Ethics Committee
Street address
Baqiyatallah University of Medical Sciences, Nosrati alley, Sheikh Bahaei Street, Mollasadra Street, Vanak Square, Tehran, I.R.Iran.
City
Tehran
Postal code
Approval date
2013-07-24, 1392/05/02
Ethics committee reference number
31

Health conditions studied

1

Description of health condition studied
allergic rhinitis
ICD-10 code
J30
ICD-10 code description
Vasomotor and allergic rhinitis

Primary outcomes

1

Description
Rhinorrhea severity
Timepoint
Before treatment, two weeks and four weeks after treatment
Method of measurement
visual analogue score (0-10)

2

Description
Itchy nose severity
Timepoint
Before treatment, two weeks and four weeks after treatment
Method of measurement
visual analogue score (0-10)

3

Description
Quality of life
Timepoint
Before treatment, two weeks and four weeks after treatment
Method of measurement
Rhino-conjunctivitis quality of life questionnaire (RQLQ)

4

Description
Eosinophil percent for nasal smears
Timepoint
Before treatment, two weeks and four weeks after treatment
Method of measurement
Nasal smears laboratory test

5

Description
Nasal obstruction severity
Timepoint
Before treatment, two weeks and four weeks after treatment
Method of measurement
visual analogue score (0-10)

Secondary outcomes

empty

Intervention groups

1

Description
Ketotifen fumarate 0.025% drop, one drop in each side of nose every 12 hours, and placebo pills every 12 hours, for four weeks
Category
Treatment - Drugs

2

Description
Placebo (distilled water) drop, one drop in each side of nose every 12 hours, and ketotifen pills, 1 mg every 12 hours, for four weeks
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Baqiyatallah University of Medical Sciences Policlinic
Full name of responsible person
Hamidreza Karimi Sari
Street address
Baqiyatallah Polyclinic, Nosrati alley, Sheikh Bahaei St. Mollasadra St. Vanak Sq. Tehran, I.R.Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Baqiyatallah University of Medical Sciences, Deputy of Research
Full name of responsible person
Esmaeil Arefzadeh
Street address
Baqiyatallah University of Medical Sciences, Nosrati alley, Sheikh Bahaei Street, Mollasadra Street, Vanak Square, Tehran, I.R.Iran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Baqiyatallah University of Medical Sciences, Deputy of Research
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
Students’ Research Committee (SRC), Baqiyatallah University of Medical Sciences, Tehran, IR Iran
Full name of responsible person
Hamidreza Karimi Sari
Position
General Practitioner
Other areas of specialty/work
Street address
Baqiyatallah University of Medical Sciences, Nosrati alley, Sheikh Bahaei Street, Mollasadra Street, Vanak Square, Tehran, I.R.Iran.
City
Tehran
Postal code
Phone
+98 21 8126 4354
Fax
+98 21 8126 4354
Email
dr.karimih@yahoo.com
Web page address
http://bmsusrc.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Department of ENT, Baqiyatallah University of Medical Sciences, Tehran, Iran
Full name of responsible person
Ashghar Akhavan
Position
Associate Professor
Other areas of specialty/work
Street address
Baqiyatallah University of Medical Sciences, Nosrati alley, Sheikh Bahaei Street, Mollasadra Street, Vanak Square, Tehran, I.R.Iran.
City
Tehran
Postal code
Phone
+98 21 8126 4354
Fax
Email
dr_akhavan_ent@yahoo.com
Web page address
http://a_akhavan.cv.research.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
Students’ Research Committee (SRC), Baqiyatallah University of Medical Sciences (BMSU), Tehran, Iran
Full name of responsible person
Hamidreza Karimi Sari
Position
General Practitioner
Other areas of specialty/work
Street address
Baqiyatallah University of Medical Sciences, Nosrati alley, Sheikh Bahaei Street, Mollasadra Street, Vanak Square, Tehran, I.R.Iran.
City
Tehran
Postal code
Phone
+98 21 8126 4354
Fax
+98 21 8126 4354
Email
dr.karimih@yahoo.com
Web page address
http://bmsusrc.ir/

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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