A comparison between the effects of nasal lavage using solutions of hypertonic saline, isotonic saline and hypotonic saline in treating the symptoms of chronic sinusitis
Nasal lavage as an adjuvant inexpensive and easy treatment treatment is used in the sinonasal diseases like sinusitis. Several papers have also reported clinical symptoms of sinus . Reviews of the studies suggest that there is not a single opinion concerning the superiority of one of the triple solutions of hypertonic saline, hypotonic saline or isotonic saline in treating the symptoms of sinusitis. This clinical trial study is on 185 patients with chronic sinusitis referred to Imam Khomeini and Apadana hospitals in Ahvaz. With a diagnosis of chronic sinusitis by an ear, nose and throat specialist and using the CT scan the patients have been selected. For collecting the data the necessary symptoms and information on the patients are recorded in a standard information gathering questionnaire. The patients are completely randomly divided into four groups. The first group will receive just medication; the second group will receive medication as well as nasal lavage or hyper saline; the third group will receive medication in addition to nasal lavage or isotonic saline; the fourth group will receive medication plus nasal lavage or hypotonic saline.then groups will compare in terms of treating the symptoms of sinusitis.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015021020320N2
Registration date:2015-07-02, 1394/04/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-07-02, 1394/04/11
Registrant information
Name
Somayeh Araghi
Name of organization / entity
ENT Department of the Jondishapour Ahvaz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3333 9664
Email address
araghi.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jondishapor University of Medical Sciences
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2015-03-21, 1394/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison between the effects of nasal lavage using solutions of hypertonic saline, isotonic saline and hypotonic saline in treating the symptoms of chronic sinusitis
Public title
effects of nasal lavage using solutions of hypertonic saline, isotonic saline and hypotonic saline in treating the symptoms of chronic sinusitis
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: chronic sinusitis
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
185
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 Jondishapour Ahvaz University of Medical Sciences
Street address
Jondishapour Ahvaz University of Medical Sciences, Golestan
City
Ahvaz
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
ETh-022
Health conditions studied
1
Description of health condition studied
Chronic sinusitis
ICD-10 code
J32
ICD-10 code description
Chronic sinusitis
Primary outcomes
1
Description
Headache
Timepoint
before treatment and 3 months later
Method of measurement
lack of the effect (1 score), minor effect (2 scores), the relative effect (3 scores) or the full effect (4 scores)
2
Description
Discharge from the nose and throat
Timepoint
before treatment and 3 months later
Method of measurement
lack of the effect (1 score), minor effect (2 scores), the relative effect (3 scores) or the full effect (4 scores)
3
Description
Nasal obstruction
Timepoint
before treatment and 3 months later
Method of measurement
lack of the effect (1 score), minor effect (2 scores), the relative effect (3 scores) or the full effect (4 scores)
4
Description
Coughing
Timepoint
before treatment and 3 months later
Method of measurement
lack of the effect (1 score), minor effect (2 scores), the relative effect (3 scores) or the full effect (4 scores)
5
Description
Olfactory problems
Timepoint
before treatment and 3 months later
Method of measurement
lack of the effect (1 score), minor effect (2 scores), the relative effect (3 scores) or the full effect (4 scores)
6
Description
Feeling of fullness in the face
Timepoint
before treatment and 3 months later
Method of measurement
lack of the effect (1 score), minor effect (2 scores), the relative effect (3 scores) or the full effect (4 scores)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1- medication as well as nasal lavage of hypertonic saline
Category
Treatment - Drugs
2
Description
Intervention group 2-medication in addition to nasal lavage of isotonic saline
Category
Treatment - Drugs
3
Description
Intervention group 3- medication plus nasal lavage of hypotonic saline
Category
Treatment - Drugs
4
Description
Control goup - just medication recieve
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Imam Khomeini Hospital
Full name of responsible person
Somayeh Araghi
Street address
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor of Ahvaz Jondishapour University of Medical Sciences
Full name of responsible person
Nader Saki
Street address
ENT Department, Imam Khomeini Hospital , 24 Metri Avenue, Ahavz, Iran
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor of Ahvaz Jondishapour 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
Jondishapour Ahvaz University of Medical Sciences
Full name of responsible person
Dr.Somaye Araghi
Position
Resident
Other areas of specialty/work
Street address
ENT Department, Imam Khomeini Hospital, 24 Metri Street
City
Ahvaz
Postal code
Phone
+98 61 3333 9664
Fax
Email
savesina@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
ENT Departmen,Jundishapur University of Medical Sciences
Full name of responsible person
Somayeh Araghi
Position
Resident of ENT
Other areas of specialty/work
Street address
ENT Department, Imam Khomeini Hospiatl
City
Ahvaz
Postal code
Phone
+98 61 3333 9664
Fax
Email
savesina@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Dr. Somayeh Araghi
Position
Resident
Other areas of specialty/work
Street address
ENT Department, 24 Metri Avenue, Imam Khomeini Hospital, Ahvaz
City
Ahvaz
Postal code
Phone
00
Fax
Email
savesina@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)