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IRCT20170117032025N7 IRCT 2020-07-12 Hamedan University of Medical Sciences Effectiveness of Mouthwashes in Early Reducing the mouth Viral Load Among COVID-19 Patients Evaluation of the Effectiveness of Mouthwashes in Early Reducing the mouth Viral Load Among COVID-19 Patients: A double-blind randomized clinical trial 2020-07-11 anticipated 60 Complete https://irct.ir/trial/49534 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: We prepare four sheets of paper and write on one sheet the letter P meaning Povidone-iodine, O meaning hydrogen peroxide, C meaning Cetylpyridinium, and N meaning normal saline. Mix the sheets and place them in the desk drawer. Upon referral to each of the eligible patients, one of the sheets will be randomly removed and assigned to one of the three intervention or control groups, and this will continue until the sample size is completed, Blinding description: All four groups will receive a mouthwash with the same appearance, which is marked with a code, and the patient and the person responsible for RT-PCR testing and the person responsible for collecting the type of drug used by the patient will be unaware. 3 Early reduction in COVID-19 viral load. Intervention 1: Intervention group: In intervention group 1, patients will gargle and rinse 20 cc of 2% Povidone-iodine mouthwash in the mouth for 20 seconds. Intervention 2: Intervention group: In intervention group 2, patients will gargle and rinse 20 cc of 1% hydrogen peroxide mouthwash for 20 seconds in the mouth. Intervention 3: In intervention group 3, patients will gargle and rinse 20 cc of Cetylpyridinium chloride mouthwash for 20 seconds. Intervention 4: Control group: In the patient control group, 20 cc of normal saline mouthwash will be gargled and rinsed inside the mouth for 20 seconds. 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 There is no more information.
public Dr Ali Heidari
Shahid Fahmideh street
Hamadan Iran (Islamic Republic of) 6517838698 +98 81 3525 0182 aliheidari55@gmail.com Hamedan University of Medical Sciences scientific Dr Ali HeidariŁ
Shahid Fahmideh street
Hamadan Iran (Islamic Republic of) 6517838698 +98 81 3525 0182 aliheidari55@gmail.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Clinical diagnosis of COVID-19 infection based on the opinion of the treating physician based on national guidelines Patients with mild to moderate disease 18 years 70 years Both Patients with previous underlying oral disease Patients with inability to properly perform the mouthwash protocol Patients with thyroid disorders D10.3 Other and unspecified parts of mouth Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: In intervention group 1, patients will gargle and rinse 20 cc of 2% Povidone-iodine mouthwash in the mouth for 20 seconds. Intervention group: In intervention group 2, patients will gargle and rinse 20 cc of 1% hydrogen peroxide mouthwash for 20 seconds in the mouth. In intervention group 3, patients will gargle and rinse 20 cc of Cetylpyridinium chloride mouthwash for 20 seconds. Control group: In the patient control group, 20 cc of normal saline mouthwash will be gargled and rinsed inside the mouth for 20 seconds. Early reduction of viral load in the mouth of COVID-19 patients. Timepoint: A sample of oropharyngeal swap will be taken from patients to check for viral load before intervention. Patients then use 20 cc of the appropriate mouthwash, based on the assigned group, which will be practically taught by the researcher on how to use it. After 30 minutes from the beginning of the intervention, the second sample of oropharyngeal swap will be determined to determine the virus load. After preparation, all samples will be placed in a tube containing a special medium for transmission (VTM) and will be transferred to the specialized reference laboratory COVID-19 of Hamadan University of Medical Sciences to determine the load of the virus by standard RT-PCR method. Method of measurement: A sample of an oropharyngeal swap will be taken from patients to check for viral load before intervention. After 30 minutes from the start of the intervention, a second oropharyngeal swap will be performed to determine the virus load. Hamedan University of Medical Sciences Approved 2020-06-04 Hamadan University of Medical Sciences Shahid Fahmideh boulvard Hamadan Hamadan Iran (Islamic Republic of)