Protocol summary
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Study aim
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Study of the effect of Sinamaz on the prevention of upper respiratory diseases (URD) among Iranian Arbaeen Pilgrims
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Design
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This study is a double-blind, randomized, placebo-controlled clinical trial on 180 healthy Iranian Arbaeen Pilgrims. 180 codes were randomized with Excel software.
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Settings and conduct
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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 Arbaeen Pilgrims use one drop in each side of their nose twice a day for 1 week. The questionnaire is completed on days 0 and The end of the trip
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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90 healthy Iranian َArbaeen Pilgrims use one drop of Cinnamase oil in each side of their nose twice a day for 1 week. 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 on each side of their nose twice a day for 1 week.
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Main outcome variables
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Clinical signs of of upper respiratory diseases
General information
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Reason for update
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The doctors could not fill out the questionnaires.
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Acronym
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URD
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IRCT registration information
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IRCT registration number:
IRCT20210515051305N2
Registration date:
2023-05-24, 1402/03/03
Registration timing:
prospective
Last update:
2024-09-14, 1403/06/24
Update count:
1
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Registration date
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2023-05-24, 1402/03/03
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Registrant information
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Recruitment status
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recruiting
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Funding source
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Expected recruitment start date
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2023-07-23, 1402/05/01
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Expected recruitment end date
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2025-08-11, 1404/05/20
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Study of the effect of Sinamaz on the prevention of upper respiratory diseases (URD) among Iranian arbaeen Pilgrims
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Public title
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The effect of Sinamaz drops on the prevention of upper respiratory diseases among Iranian arbaeen Pilgrims
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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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
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Age
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No age limit
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Gender
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Both
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Phase
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2
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
180
More than 1 sample in each individual
Number of samples in each individual:
4
Filling the questionnaire
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-05-08, 1402/02/18
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Ethics committee reference number
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IR.SHAHED.REC.1402.001
Health conditions studied
1
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Description of health condition studied
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Upper respiratory diseases
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ICD-10 code
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J39
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ICD-10 code description
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Other diseases of upper respiratory tract
Primary outcomes
1
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Description
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Clinical signs of of upper respiratory diseases
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Timepoint
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The questionnaire is completed on days 0, 3 and 7.
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Method of measurement
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Questionnaire
Intervention groups
1
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Description
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Intervention group: 90 healthy Iranian Arbaeen Pilgrims use one drop of Cinnamase oil in each side of their nose twice a day for 1 week. The questionnaire is completed on days 0, 3, and 7. 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.
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Category
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Treatment - Drugs
2
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Description
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90 healthy Iranian Arbaeen Pilgrims use one placebo drop on each side of their nose twice a day for 1 week. The questionnaire is completed on days 0 and 3, 7.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Traditional Medicine Clinical Trial Research Center,Shahed University, Tehran, Iran
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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Clinical study report: published as an article.
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When the data will become available and for how long
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6 months after printing the results in the form of an article
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To whom data/document is available
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Researchers working in institutions and individuals in the industrial sector can apply to a scientific respondent.
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Under which criteria data/document could be used
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It is possible to use the documents after publishing the extracted article with a scientifically responsive opinion.
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From where data/document is obtainable
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Email: naseri@shahed.ac.ir naserishahed@yahoo.com
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What processes are involved for a request to access data/document
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The email will be reviewed by the applicant at least two days after the application is sent and will be answered within a week.
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Comments
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