Determination of the efficacy of xylitol nasal spray in the treatment of patients with chronic rhinosinusitis
Design
A clinical trial with a control group, double blinded, randomized
Settings and conduct
This trial study was performed on 30 patients with chronic rhinosinusitis who referred to Alzahra Hospital Clinic. Then patients are divided into two groups randomly. The first group received either the nasal spray intervention xylitol and the second group or placebo nasal spray. Patients are visited on two occasions, on the first visit on arrival and on the second visit 30 days after treatment, on the first visit demographic information including age, sex, duration of illness, and BMI for patients is recorded, Then, after physical examination and endoscopic examination of the sinuses, the Lund Kennedy score is calculated by an ENT expert according to the endoscopic examination.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with chronic rhinosinusitis; They had previously undergone sinus endoscopy and now need only non-surgical treatments; Exclusion criteria: Patients who have a history of allergic rhinitis, Asthma, Immunodeficiency, Cystic fibrosis, Primary pulmonary dyskinesia, Active bacterial or fungal infection and need antibiotics or antifungals; Have a history of head and neck radiation therapy; Now be a smoker; Pregnant people; Have granulomatous disease
Intervention groups
We have two groups. The first group received either the nasal spray intervention xylitol and the second group or placebo nasal spray.
Main outcome variables
Duration of illness; Lund Kennedy; SNOT 22 (Sino-nasal Outcome Test); Severity of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171030037093N35
Registration date:2020-04-11, 1399/01/23
Registration timing:registered_while_recruiting
Last update:2020-04-11, 1399/01/23
Update count:0
Registration date
2020-04-11, 1399/01/23
Registrant information
Name
Sadra Ansaripour
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3650 3487
Email address
st_ansari.s@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-07, 1399/01/19
Expected recruitment end date
2020-05-03, 1399/02/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Xylitol nasal spray in treatment of patients with chronic rhinosinusitis
Public title
Effect of Xylitol nasal spray in treatment of chronic rhinosinusitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with chronic rhinosinusitis
Age over 18 years
They had previously undergone sinus endoscopy and now need only non-surgical treatments.
Exclusion criteria:
Patients who have a history of allergic rhinitis, asthma, immunodeficiency, cystic fibrosis, primary pulmonary dyskinesia, active bacterial or fungal infection and need antibiotics or antifungals
Patients who are unsatisfied with non-surgical treatment or want to have surgery again for any reason
Have a history of head and neck radiation therapy
Now be a smoker
Pregnant people
Have granulomatous disease
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The sample was randomly divided into two groups of 15 patients. Each envelope containing one of the two labels A and B represented one of the intervention groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
For the purpose of blinding, neither the patients nor the researchers were aware of the type of treatment each group received until the completion of the study. The treatments were divided into two groups as closed packages with codes A and B that were assigned to group A packages containing code A and group B packages containing code B.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahn University of Medical Sciences, Hezar jarib st, Isfahan
City
Isfahan
Province
Isfehan
Postal code
7346181746
Approval date
2020-01-14, 1398/10/24
Ethics committee reference number
IR.MUI.MED.REC.1398.521
Health conditions studied
1
Description of health condition studied
Rhinosinusitis
ICD-10 code
J32.9
ICD-10 code description
Chronic sinusitis, unspecified
Primary outcomes
1
Description
Lund Kennedy Score
Timepoint
Before and after the study
Method of measurement
Lund Kennedy questionnaire
2
Description
SNOT 22 (Sino-nasal Outcome Test) score
Timepoint
Before the intervention and 30 days after the intervention
Method of measurement
SNOT 22 (Sino-nasal Outcome Test)
3
Description
Severe pain when pressing on the sinuses
Timepoint
Before and after the study
Method of measurement
VAS (Visual Analog Scale) questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: xylitol nasal spray intervention group is given two puffs every 8 hours for 30 days.
Category
Treatment - Drugs
2
Description
Control group: The second group, or placebo, received normal saline two puffs every 8 hours for 30 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Ahmad Rezaeian
Street address
Soffeh Boulevard
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3445 2031
Email
ahmadrezaeian@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooy Javanmard
Street address
Isfahan University of Medical Sciences, Hezar jarib Avne
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 0048
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ahmad Rezaeian
Position
Assistant Professor of ear, nose and throat
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Alzahra hospital
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3556 5175
Email
ahmadrezaeian@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ahmad Rezaeian
Position
Assistant Professor of ear, nose and throat
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Alzahra hospital
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3556 5175
Email
ahmadrezaeian@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ahmad Rezaeian
Position
Assistant Professor of ear, nose and throat
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Alzahra hospital
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3445 2031
Email
ahmadrezaeian@med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available