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Effect of Nasil drop (sesame based black seeds) versus placebo on treatment of chronic rhinosinusitis: a triple blind randomized clinical trial

Protocol summary

Summary
Objectives: To assess the effect of Nasil drop (sesame based black seeds) versus placebo on treatment of chronic rhinosinusitis. Design: a triple blind randomized clinical trial. Setting and conduct: The eligible patients with chronic rhinosinusitis who will refer to Besat Hospital during the study period will be enrolled into the trial. Inclusion criteria: Age of 18 to 64 years; chronic rhinosinusitis. Exclusion criteria: Pregnancy; fever; immunosuppression; nasal polyp; sensitivity to black seeds or sesame. Intervention group: Nasil drop (sesame based black seeds) one drop in the right nostril at the first night, one drop in the left nostril at the second night, two drops in the right nostril at the third night, two drops in the left nostril at the fourth night; three drops in the right nostril at the fifth night and three drops in the left nostril at the sixth night; then, the drop will be quit for one week and again drop will be started the same way once more. Control group: Placebo drop (including distilled water) one drop in the right nostril at the first night, one drop in the left nostril at the second night, two drops in the right nostril at the third night, two drops in the left nostril at the fourth night; three drops in the right nostril at the fifth night and three drops in the left nostril at the sixth night; then, the drop will be quit for one week and again drop will be started the same way once more. Primary outcome: (a) status of rhinosinusitis based on Vas score before intervention, immediately after intervention and 3 weeks later; (b) status of rhinosinusitis based on Snot-22 score before intervention, immediately after intervention and 3 weeks later; (c) status of rhinosinusitis based on endoscopic before intervention, immediately after intervention and 3 weeks later. Randomization: The patients will be randomly assigned to intervention and control groups using block randomization. Blinding: Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. The analyzer will be unaware of the type of interventions. Therefore, the trial will be run as triple blind.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201703079014N149
Registration date: 2017-03-12, 1395/12/22
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-03-12, 1395/12/22
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2017-04-04, 1396/01/15
Expected recruitment end date
2017-09-22, 1396/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Nasil drop (sesame based black seeds) versus placebo on treatment of chronic rhinosinusitis: a triple blind randomized clinical trial
Public title
Effect of Nasil drop (sesame based black seeds) versus placebo on treatment of chronic rhinosinusitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age of 18 to 64 years; chronic rhinosinusitis. Exclusion criteria: Pregnancy; fever; immunosuppression; nasal polyp; sensitivity to black seeds or sesame.
Age
From 18 years old to 64 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization: The patients will be randomly assigned to intervention and control groups using block randomization. Blinding: Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. The analyzer will be unaware of the type of interventions. Therefore, the trial will be run as triple blind.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2016-04-09, 1395/01/21
Ethics committee reference number
IR.UMSHA.REC.1395.3

Health conditions studied

1

Description of health condition studied
chronic rhinosinusitis
ICD-10 code
J32.9
ICD-10 code description
Chronic sinusitis, unspecified

Primary outcomes

1

Description
status of rhinosinusitis
Timepoint
before intervention, immediately after intervention and 3 weeks later
Method of measurement
based on Vas score

2

Description
status of rhinosinusitis
Timepoint
before intervention, immediately after intervention and 3 weeks later
Method of measurement
based on Snot-22 score

3

Description
status of rhinosinusitis
Timepoint
before intervention, immediately after intervention and 3 weeks later
Method of measurement
based on endoscopic

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Nasil drop (sesame based black seeds) one drop in the right nostril at the first night, one drop in the left nostril at the second night, two drops in the right nostril at the third night, two drops in the left nostril at the fourth night; three drops in the right nostril at the fifth night and three drops in the left nostril at the sixth night; then, the drop will be quit for one week and again drop will be started the same way once more.
Category
Treatment - Drugs

2

Description
Control group: Placebo drop (including distilled water) one drop in the right nostril at the first night, one drop in the left nostril at the second night, two drops in the right nostril at the third night, two drops in the left nostril at the fourth night; three drops in the right nostril at the fifth night and three drops in the left nostril at the sixth night; then, the drop will be quit for one week and again drop will be started the same way once more.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Dr Tahereh Mozayyan
Street address
Besat Hospital, Shahed Square
City
Hamadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research the Technology, Hamadan 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
Besat Hospital
Full name of responsible person
Dr Tahereh Mozayyan
Position
Resident of ENT
Other areas of specialty/work
Street address
Besat Hospital, Shahed Square
City
Hamadan
Postal code
Phone
+98 81 3364 0030
Fax
Email
dr_t_mozayyan@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Besat Hospital
Full name of responsible person
Dr Rooholah Abbasi
Position
ENT specialist
Other areas of specialty/work
Street address
Besat Hospital, Shahed Square
City
Hamadan
Postal code
Phone
+98 81 3364 0030
Fax
Email
r.abbasi@umsha.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@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
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