Study of the effect of Sinamaz on the prevention of upper respiratory diseases (URD) among Iranian Hajj Pilgrims
Design
This study is a double-blind, randomized, placebo-controlled clinical trial on 180 healthy Iranian Hajj Pilgrims. 180 codes were randomized with Excel software.
Settings and conduct
The informed consent form is signed by the candidates participating in the study or their legal guardians if they have not reached the legal age. Relevant questionnaires are completed. Sinamaz and placebo are provided by the manufacturer with similar containers. Special codes are inserted on the package that will be kept confidential until the end of the study. Healthy Iranian Hajj Pilgrims use one drop in each side of their nose twice a day for 5 weeks. The questionnaire is completed on days 0, 14, 28, and The end of the trip
Participants/Inclusion and exclusion criteria
Signing consent forms by volunteers participating in the study; Volunteers should not have respiratory disease symptoms; Volunteers should not participate in other clinical trials; People who are suffering from certain underlying diseases or receiving drugs such as corticosteroids or immunosuppressants nor who have any history of nose or septum surgery are not approved as volunteers.
Intervention groups
90 healthy Iranian Hajj Pilgrims use one drop of Cinnamase oil in each side of their nose twice a day for 5 weeks. Sinamaz drops (License number: 118880/665)is the product of "Sanabel Daroo" company. This drug is a product derived from the knowledge of Iranian traditional medicine, which is scientifically prepared from Nigella sativa L. oil and Olea europaea L oil. Control group: 90 healthy Iranian Hajj Pilgrims use one drop of placebo in each side of their nose twice a day for 5 weeks.
Main outcome variables
Clinical signs of of upper respiratory diseases
General information
Reason for update
Acronym
URD
IRCT registration information
IRCT registration number:IRCT20210515051305N2
Registration date:2023-05-24, 1402/03/03
Registration timing:registered_while_recruiting
Last update:2023-05-24, 1402/03/03
Update count:0
Registration date
2023-05-24, 1402/03/03
Registrant information
Name
Zahra Bahaeddin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6646 4320
Email address
z.bahaedin@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-24, 1402/03/03
Expected recruitment end date
2024-07-22, 1403/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of Sinamaz on the prevention of upper respiratory diseases (URD) among Iranian Hajj Pilgrims
Public title
The effect of Sinamaz drops on the prevention of upper respiratory diseases among Iranian Hajj Pilgrims.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Signing consent forms by volunteers participating in the study
Volunteers should not have respiratory diseases symptoms
Volunteers should not participate in other clinical trials
people who are suffering from certain underlying diseases or receiving drugs such as corticosteroids or immunosuppressants nor who have any history of nose or septum surgery are not approved as Volunteers
Exclusion criteria:
Allergy to herbal medicines and and natural oils
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
180
More than 1 sample in each individual
Number of samples in each individual:
4
Filling the questionnaire
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible participants will be randomly assigned into 2
groups in a 1:1 ratio using a block randomization method
with a block length of 2 by PROC PLAN of SAS 9.4. An
independent statistician generates the randomization
number sequence. The drug codes will be attached after
the manufacturing and packaging of the experiment
treatment and placebo. The drugs will be allocated
sequentially according to the screening order of the
patients. Group assignment will be kept in an opaque
and sealed envelope and will be opened after data
analysis by another statistician.
Blinding (investigator's opinion)
Double blinded
Blinding description
The coding is done in two groups and placebo by a person who does not interfere in the plan and keeps the codes confidential. Until the end of the study, the researcher, doctor and project colleagues are not aware of it.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahed University
Street address
Shahed University, In front of the holy shrine of Imam Khomeini, Qom freeway,Tehran , Iran.
City
Tehran
Province
Tehran
Postal code
3319118651
Approval date
2023-05-08, 1402/02/18
Ethics committee reference number
IR.SHAHED.REC.1402.001
Health conditions studied
1
Description of health condition studied
Upper respiratory diseases
ICD-10 code
J39
ICD-10 code description
Other diseases of upper respiratory tract
Primary outcomes
1
Description
Clinical signs of of upper respiratory diseases
Timepoint
The questionnaire is completed on days 0, 14, 28, and The end of the trip
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 90 healthy Iranian Hajj Pilgrims use one drop of Cinnamase oil in each side of their nose twice a day for 5 weeks. The questionnaire is completed on days 0, 14, 28, and The end of the trip. Sinamaz drops (License number: 118880/665)is the product of "Sanabel Daroo" company. This drug is a product derived from the knowledge of Iranian traditional medicine, which is scientifically prepared from Nigella sativa L. oil and Olea europaea L oil.
Category
Treatment - Drugs
2
Description
90 healthy Iranian Hajj Pilgrims use one drop of placebo in each side of their nose twice a day for 5 weeks. The questionnaire is completed on days 0, 14, 28, and The end of the trip
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Iranian Red Crescent Clinic
Full name of responsible person
Mohsen Naseri
Street address
No.1471, North Kargar Street, Enghelab Square,Tehran , Iran.
City
Tehran
Province
Tehran
Postal code
1417953836
Phone
+98 21 6646 4320
Email
naseri@shahed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Shahriar Bijani
Street address
Shahed University, In front of the holy shrine of Imam Khomeini, Qom freeway,Tehran , Iran.
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 5116
Email
Bijani@shahed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Traditional Medicine Clinical Trial Research Center,Shahed University, Tehran, Iran
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
Shahed University
Full name of responsible person
Mohsen Naseri
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No.1471, North Kargar Street, Enghelab Square,Tehran , Iran.
City
Tehran
Province
Tehran
Postal code
1417953836
Phone
+98 21 6646 4320
Email
naserishahed@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Mohsen Naseri
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No.1471, North Kargar Street, Enghelab Square,Tehran , Iran.
City
Tehran
Province
Tehran
Postal code
1417953836
Phone
+98 21 6646 4320
Email
naseri@shahed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahed University
Full name of responsible person
zahra bahaeddin
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No.1471, North Kargar Street, Enghelab Square,Tehran, Iran.
City
tehran
Province
Tehran
Postal code
1417953836
Phone
+98 21 6646 4320
Email
z.bahaedin@gmail.com
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
Yes - There is 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
Title and more details about the data/document
Clinical study report: published as an article.
When the data will become available and for how long
6 months after printing the results in the form of an article
To whom data/document is available
Researchers working in institutions and individuals in the industrial sector can apply to a scientific respondent.
Under which criteria data/document could be used
It is possible to use the documents after publishing the extracted article with a scientifically responsive opinion.
From where data/document is obtainable
Email: naseri@shahed.ac.ir naserishahed@yahoo.com
What processes are involved for a request to access data/document
The email will be reviewed by the applicant at least two days after the application is sent and will be answered within a week.