This research is randomized double-blind clinical trial. The patients who referred to ENT clinic and chronic rhinosinusitis (CRS) were diagnosed based on the AAO-HNS definition of CRS, randomly divided to 2 groups. One group as conrol, receive placebo and beclomethasone nasal spray and the intervention group receive fluconazole drop and beclomethasone nasal spray every 12 hours. The bottle of drops is coded by pharmaceutical faculty of Tehran University. Treatment courses last for 2 months. Endoscopic score and SNOT-20 instruction and CT score is recorded before and after treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138811063186N1
Registration date:2011-08-02, 1390/05/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-08-02, 1390/05/11
Registrant information
Name
Farnaz Hashemian
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3827 9001
Email address
hashemian@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan University of Medical Science
Expected recruitment start date
2009-04-04, 1388/01/15
Expected recruitment end date
2011-03-20, 1389/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the therapeutic effect of fluconazol drop on chronic rhinosinusitis in patients reffered to otorhinolarnyngology clinic in Hamadan
Public title
Evaluation of the therapeutic effect of fluconazol drop on chronic rhinosinusitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: the patients with diagnosis of chronic rhinosinusitis according to American Academy of Otolaryngology which have no response to medical therapy;
Exclusion criteria: known sensitivity to fluconazole; pregnancy and breast feeding women; immune compromised patients; patients with acute complication of CRS; superimposition of ARS(fever, acute pain, pressure on face); antibiotic use in recent 7 days ; age below 18 years; systemic antifungal use in recent 7 days and systemic steroid use in recent 30 days
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
54
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 Hamadan University of Medical Science
Street address
Hamedan University of Medical Sciences, shaheed Fahmideh Ave.Hamedan, Iran
City
Hamadan
Postal code
65178-3-8736
Approval date
2009-01-20, 1387/11/01
Ethics committee reference number
16/35/9/56549
Health conditions studied
1
Description of health condition studied
rhinosinusitis
ICD-10 code
(B95-B97)
ICD-10 code description
Bacterial, viral and other infectious agents
Primary outcomes
1
Description
snot-20
Timepoint
2 months
Method of measurement
Check list
2
Description
CT score
Timepoint
2 months
Method of measurement
Check list
Secondary outcomes
1
Description
Side effect
Timepoint
2 months
Method of measurement
Check list
Intervention groups
1
Description
Intervention group: drop bottles including fluconazole 2%. is used 2 times per day (4 drops) for 2 months, also beclomethasone nasal spray is used 2 times per day (2 puffs) for 2 months.
Category
Treatment - Drugs
2
Description
Control group: drop bottles with the appearance identical to intervention group, includes normal saline which is used 2 times per day, 4 drops, for 2 months. Also beclomethasone nasal spray is used 2 times per day (2 puffs) for 2 months.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
ENT clinics of Hamedan University of Medical Science
Full name of responsible person
Street address
Hamedan, Sheikholraiss clinic and Besat hospital
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Science
Full name of responsible person
Tavilani-Heydar
Street address
Shahid Fahmideh Blv, Hamedan University of Medical Science
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Science
Full name of responsible person
Farnaz Hashemian
Position
Assistant professor
Other areas of specialty/work
Street address
Hamedan university of medical science-Shaheed Fahmideh Blv. Hamedan
City
Hamedan
Postal code
Phone
+98 81 1264 0039
Fax
Email
hashemianf@yahoo.com; hashemian@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Science
Full name of responsible person
Farnaz Hashemian
Position
Rhinology fellow ship
Other areas of specialty/work
Street address
Hamedan university of medical science-Shaheed Fahmideh Blv. Hamedan -Iran
City
Hamedan
Postal code
Phone
+98 81 1264 0039
Fax
Email
hashemianf@yahoo.com; hashemian@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Science
Full name of responsible person
Hashemian Farnaz
Position
Assistant professor
Other areas of specialty/work
Street address
Hamedan University of Medical Science, shahid Fahmideh Blv, Hamedan
City
Hamedan
Postal code
Phone
+98 81 1839 5403
Fax
+98 81 1826 9835
Email
hashemian@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)