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Assessing the effect of thyme-honey nasal spray on chronic rhinosinusitis

Protocol summary

Summary
Study design: randomized, double-blind, placebo-controlled, single, trial phase:0. Inclusion criteria: patients referred to Besat Hospital clinic with chronic rhinosinusitis ( according to AAO-HNS) who have not responded to medical therapy and are candidated for FESS. Exclusion criteria: age under 18 years and above 65 years; hypersensitivity to honey, pollen, thyme, bees; systemic diseases such as cystic fibrosis, immotile cilia syndrome, granulomatous diseases and diabetus mellitus. Sample size:60. Study objective: finding a better and more cost-effective way to treat chronic rhinosinusitis

General information

Acronym
thyme-honey, chronic rhinosinusitis, FESS
IRCT registration information
IRCT registration number: IRCT201204303186N2
Registration date: 2012-12-05, 1391/09/15
Registration timing: na

Last update:
Update count: 0
Registration date
2012-12-05, 1391/09/15
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
Not enough for processing
Funding source
Hamedan university of medical sciences
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2012-09-21, 1391/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the effect of thyme-honey nasal spray on chronic rhinosinusitis
Public title
Assessing the effect of thyme-honey nasal spray on chronic rhinosinusitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: patients referred to Besat Hospital clinic with chronic rhinosinusitis ( according to AAO-HNS) who have not responded to medical therapy and are candidated for FESS. Exclusion criteria: age under 18 years and above 65 years; hypersensitivity to honey, pollen, thyme, bees; systemic diseases such as cystic fibrosis, immotile cilia syndrome, granulomatous diseases and diabetus mellitus.
Age
From 18 years old to 65 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Hamedan university of medical sciences
Street address
Hamedan university of medical sciences,Shahid Fahmideh street,Hamedan.
City
Hamedan
Postal code
65178
Approval date
2012-05-16, 1391/02/27
Ethics committee reference number
16/35/9/625/پ/د

Health conditions studied

1

Description of health condition studied
Chronic rhinosinusitis
ICD-10 code
J32
ICD-10 code description
Chronic sinusitis

Primary outcomes

1

Description
chronic rhinosinusitis
Timepoint
before, 1 week, 1 month, 2 months after intervention
Method of measurement
Snot-22 questionnaire, CT-scan score, Philpott-Javer endoscopic score

Secondary outcomes

1

Description
hypersensitivity
Timepoint
1 week, 1 month and 2 months after intervention
Method of measurement
questionnaire, physical examination

2

Description
burning sensation
Timepoint
1 week, 1 month, 2 months after intervention
Method of measurement
questionnaire

3

Description
epistaxis
Timepoint
1 week, 1 month and 2 months after intervention
Method of measurement
questionnaire, physical examination

Intervention groups

1

Description
intervention group: thyme honey/ spray/ twice a day/ 3 puffs each nasal cavity control group: distilled water/ spray/ twice a day/ 3 puffs each nasal cavity
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Besat hospital, ENT clinic
Full name of responsible person
Street address
City
Hamedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan university of medical sciences
Full name of responsible person
Tavilani Heydar
Street address
Hamedan
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 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
Hamedan university of medical sciences
Full name of responsible person
Farnaz Hashemian
Position
associate professor
Other areas of specialty/work
Street address
Besat hospital,shahid Beheshti Blvd.,Hamedan
City
Hamedan
Postal code
Phone
+98 81 1264 0047
Fax
Email
hashemian@umsha.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan university of medical sciences
Full name of responsible person
Farnaz Hashemian
Position
associate professor
Other areas of specialty/work
Street address
Besat hospital,shahid Beheshti Blvd., Hamedan
City
Hamedan
Postal code
Phone
+98 81 1264 0047
Fax
Email
hashemian@umsha.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamedan university of medical sciences
Full name of responsible person
Farnaz Hashemian
Position
associate professor
Other areas of specialty/work
Street address
Besat hospital,shahid Beheshti Blvd., Hamedan.
City
Hamedan
Postal code
Phone
+98 81 1264 0047
Fax
Email
hashemian@umsha.ac.ir
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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