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IRCT20210515051305N2 IRCT 2023-05-24 Shahed University The effect of Sinamaz drops on the prevention of‏ ‏upper respiratory diseases ‎among Iranian arbaeen Pilgrims URD Study of the effect of Sinamaz on the prevention of‏ ‏upper respiratory diseases (URD) ‎among Iranian arbaeen Pilgrims 2023-07-23 anticipated 180 Complete https://irct.ir/trial/69738 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, 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 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. 2 Upper respiratory diseases ‎. Intervention 1: 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.‎. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is The study has not yet begun. The data has not been collected yet and it will be decided later, but the results will be published
public Mohsen Naseri
No.1471, North Kargar Street, Enghelab Square,Tehran , Iran.
Tehran Iran (Islamic Republic of) 1417953836 +98 21 6646 4320 naserishahed@yahoo.com Shahed University scientific Mohsen Naseri
No.1471, North Kargar Street, Enghelab Square,Tehran , Iran.
Tehran Iran (Islamic Republic of) 1417953836 +98 21 6646 4320 naseri@shahed.ac.ir Shahed University Iran (Islamic Republic of) 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 no limit no limit Both Allergy to herbal medicines and and natural oils J39 Other diseases of upper respiratory tract Treatment - Drugs Placebo 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.‎ 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. Clinical signs of of‏ ‏upper respiratory diseases. Timepoint: The questionnaire is completed on days 0, 3 and 7. Method of measurement: Questionnaire. Traditional Medicine Clinical Trial Research Center,Shahed University, Tehran, Iran Approved 2023-05-08 Ethics Committee of Shahed University Shahed University, In front of the holy shrine of Imam Khomeini, Qom freeway,Tehran , Iran. Tehran Tehran Iran (Islamic Republic of)