Evaluating the effect of gargling with Hydrogen Peroxide 1% and Povidine Iodine 0.25% on viral load of SARS-CoV-2 in covid19 patients ; A pilot randomized clinical trial
The aim of this study is to evaluate the effect of oral rinse of povidine iodine and hydrogen peroxide mouthwash in comparison with normal saline on viral load in confirmed covid 19 patients who may undergo dental treatment.
Design
this double blinde clinical trial having control group and parallel groups and randomized phase2 in 60 participants . block randomization method using the online RANDOM.ORG software was done.
Settings and conduct
The target population will be consisted of patients of both sex who are hospitalized in shahid faghihi hospital, Namazi hospital and Aliasghar hospital, Shiraz University Of Medical Sciences, Shiraz, IRAN due to Covid -19 disease.
All the participants, the nurse which will do the sampling and the author will be blinded from each other.
Participants/Inclusion and exclusion criteria
The inclusion criteria are age 18-50,and the hospitalized confirmed covid 19 patients.
Exclusion crireria are having any systemic disease or medications that may interact with Povidine Iodine and-or Hydrogen Peroxide, patients who are not feeling well, not cooperative patients, and those who are not willing to participate in the study
Intervention groups
In each group two saliva samples is needed. first at 0 hour (before gargle), and the second, 5 to 10 minutes after using mouthwashes. Group A (n=20) patients on 10 ml gargle using 0.25% Povidone-Iodine, for 20-30 seconds.
Group B (n=20) patients will be subjected to 10 ml gargle of 1% Hydrogen peroxide for 20-30 seconds. Group C (n=20) will serve as positive control. These will be given simple normal saline gargle for 20-30 seconds,
Main outcome variables
To determine the viral load before and after the intervention.
General information
Reason for update
Acronym
SARS-COV2, Covid19
IRCT registration information
IRCT registration number:IRCT20201212049681N1
Registration date:2021-02-28, 1399/12/10
Registration timing:registered_while_recruiting
Last update:2021-02-28, 1399/12/10
Update count:0
Registration date
2021-02-28, 1399/12/10
Registrant information
Name
zahra rajabzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3631 5271
Email address
dr.zrajabzadeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-20, 1399/11/01
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
2021-01-20, 1399/11/01
Actual recruitment end date
2021-03-19, 1399/12/29
Trial completion date
2021-04-19, 1400/01/30
Scientific title
Evaluating the effect of gargling with Hydrogen Peroxide 1% and Povidine Iodine 0.25% on viral load of SARS-CoV-2 in covid19 patients ; A pilot randomized clinical trial
Public title
Evaluating the effect of gargling with Hydrogen Peroxide 1% and Povidine Iodine 0.25% on viral load of SARS-CoV-2 in covid19 patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
having age 18-50,
those who are hospitalized and have confirmed covid 19 viral contamination.
Exclusion criteria:
having any systemic disease or medications that may interact with Povidine Iodine and-or Hydrogen Peroxide
patients who are not feeling well, not cooperative patients, and those who don’t want to participate in the study
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
60
More than 1 sample in each individual
Number of samples in each individual:
2
1 sample before intervention and one sample after intervention
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The patients Will be equally divided into three experimental groups, namely, the A,B,C group. The allocation of the participants will be based on the block randomization method using the online RANDOM.ORG software. Each random number will be placed in a sealed opaque envelope and subsequently, each participant randomly will pick one envelope corresponding to either the A,B, orC group.
Blinding (investigator's opinion)
Double blinded
Blinding description
To ensure both the participants and clinicians will be blinded to the clinical trial,all the participants, the nurse which will do the sampling and the author will be blinded from each other, and are not aware of the mouthwash that is used.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University Of Medical Sciences
Street address
Department of Endodontics, School of Dentistry, Ghasrdast Street, Shiraz, Iran,
City
Shiraz
Province
Fars
Postal code
71956-15878
Approval date
2021-01-09, 1399/10/20
Ethics committee reference number
IR. SUMS. DENTAL.REC.1399.186
Health conditions studied
1
Description of health condition studied
Covid-19
ICD-10 code
RAO1.0
ICD-10 code description
severe acute respiratory syndrome corona virus
Primary outcomes
1
Description
viral load before the intervention, viral load after the intervention
Timepoint
before intervention and 5-10 minutes after intervention