The aim of this study was to investigate the effects of oral zinc supplement on clinical improvement of chronic sinusitis patients. Forty four patients with chronic sinusitis and polyposis were randomly divided into two treatment and control groups. Inclusion criteria were all patients with chronic sinusitis and polyposis. Exclusion criteria were age <18, being allergic to one of the drugs used during the study, such as zinc and oral steroids, receiving antibiotic or steroids treatment in the last 3 months before the study commencement, having surgery 3 months before the start date of the study. Treatment group were received oral dexamethasone, 2 puffs of fluticasone, fexophenadine and montelukast tablets and 2 zinc capsules on daily basis for 6 weeks. Control group were treated with the above treatment regimen except for zinc capsules. At the end of sixth weeks, the two groups were compared regarding their clinical state based on the results of the Snot20 (Sinonasal outcome test) questionnaire, general health questionnaire and Lund-Mackay (LM, computed tomography) and Lund-Kennedy (LK, endoscopic) scoring systems.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016092018143N3
Registration date:2016-11-17, 1395/08/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-11-17, 1395/08/27
Registrant information
Name
nader akbari dilmaghani
Name of organization / entity
shahid beheshti medical university
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 9005
Email address
nadakbari@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahaid Beheshti University of Medical Sciences
Expected recruitment start date
2014-01-01, 1392/10/11
Expected recruitment end date
2015-01-01, 1393/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of elemental zinc on patients with chronic sinusitis and polyposis: single-blind randomized controlled trial study
Public title
The effects of oral zinc supplementation on clinical improvement of chronic sinusitis
Purpose
Treatment
Inclusion/Exclusion criteria
Exclusion criteria: allergy to one of the drugs used during the study; zink; oral steroid; fluticasone spra; fexophenadine; montelukast; age <18 years, treatment or consumption antibiotic or steroids in the 3 months before starting of the study, having surgery 3 months before starting the study. Inclusion criteria: all patients with chronic sinusitis and polyposis who had not exclusion criteria.
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Velenjak Street
City
Tehran
Postal code
Approval date
2013-08-20, 1392/05/29
Ethics committee reference number
SBMU.REC.1392.270
Health conditions studied
1
Description of health condition studied
Chronic sinusitis and polyposis
ICD-10 code
J32.9
ICD-10 code description
Chronic sinusitis, unspecified
Primary outcomes
1
Description
Clinical state
Timepoint
At the end of sixth weeks
Method of measurement
Lund score
Secondary outcomes
empty
Intervention groups
1
Description
In this study 44 patients with chronic sinusitis and polyposis referring to ENT clinic of Loghman hospital were randomly divided into two treatment and control groups. Treatment group was treated with dexamethasone oral, fluticasone spray (2puff/daily), fexophenadine daily tablet, montelukast daily tablet and 2 zinc capsules daily for 6 weeks.
Category
Treatment - Drugs
2
Description
Control group was treated with dexamethasone oral, fluticasone spray (2puff/daily), fexophenadine daily tablet and montelukast daily tablet for six weeks. At the end of sixth weeks, the two groups were compared regarding their clinical state based on the results of the Snot20 (Sinonasal outcome test) questionnaire, general health questionnaire and Lund-Mackay (LM, computed tomography) and Lund-Kennedy (LK, endoscopic) scoring systems.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Loghman Hospital
Full name of responsible person
Nader Akbari Dilamghani
Street address
Loghman Hakim Hospital, Kamali Street, Lashkar Four-way, Southern Karegar
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
ُShahid Beheshti University of Medical Sciences
Full name of responsible person
Nader Akbari-Dilmaghani
Street address
Velenjak St
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
ُShahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nader Akbari-Dilamghani
Position
Assistant Professor
Other areas of specialty/work
Street address
Velenjak St
City
Tehran
Postal code
Phone
+98 21 5541 9005
Fax
Email
nadakari@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nader Akbari-Dilamghani
Position
Assistant Professor
Other areas of specialty/work
Street address
Velenjak
City
Tehran
Postal code
Phone
+98 21 5541 9005
Fax
Email
nadakari@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nadereh Alani
Position
Other areas of specialty/work
Street address
City
Tehran
Postal code
Phone
+98 21 8807 4936
Fax
Email
dr.nalani@muq.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)