| Trial registration number
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IRCT20200527047581N2 |
Full text link
Last imported at : March 18, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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http://en.irct.ir/trial/54884
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First author
Last imported at : March 18, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Dr. Hamidreza Banafsheh
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Contact
Last imported at : March 18, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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research@kaums.ac.ir
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Registration date
Last imported at : March 18, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2021-03-17
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Recruitment status
Last imported at : July 11, 2021, 11:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Completed
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Study design
Last imported at : March 18, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
RCT
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Allocation
Last imported at : March 18, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Randomized
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Design
Last imported at : March 18, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Parallel
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Masking
Last imported at : March 18, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Open label
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Center
Last imported at : March 18, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
single-center
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Study aim
Last imported at : March 18, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Treatment
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Inclusion criteria
Last imported at : March 18, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
possibility of involving to COVID-19
PaO2/FiO2 < 300 mm Hg or SpO2 < 93% in air ambient or need to oxygen supplementary for SpO2 in range of 94-98% or lung infiltration > 50%
consciousness of patient and to be able to complete letter of satisfaction
minimum 18 years old
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Exclusion criteria
Last imported at : March 18, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Pregnancy patient
Immunodeficiency such as patient with Severe combined immune deficiency and HIV
Allergy to mouth rinse
Immunosuppressant drug consumer such as transplantation recipient
Dissatisfaction with participating in the study
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Number of arms
Last imported at : March 18, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
4
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Funding
Last imported at : March 18, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Kashan University of Medical Sciences
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Inclusion age min
Last imported at : March 18, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
18
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Inclusion age max
Last imported at : March 18, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
100
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Countries
Last imported at : March 18, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Iran
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Type of patients
Last imported at : March 18, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Moderate/severe disease at enrollment
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Severity scale
Last imported at : March 18, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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4: Moderate/severe disease at enrollment
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Total sample size
Last imported at : March 18, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
180
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primary outcome
Last imported at : March 18, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Duration of hospitalization
Xerostomia
Change of Taste sense
New oral erythematous lesion
new oral ulcer
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Notes
Last imported at : March 18, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
|
Phase
Last imported at : March 18, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase 2/Phase 3
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Arms
Last imported at : March 18, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
[{"arm_notes": "", "treatment_id": 1453, "treatment_name": "Chlorhexidine+povidone-iodine", "treatment_type": "Mouthwash", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 274, "treatment_name": "Chlorhexidine", "treatment_type": "Mouthwash", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1015, "treatment_name": "Povidone-iodine", "treatment_type": "Mouthwash", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]
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