| Trial registration number
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JPRN-jRCTs051210107 |
Full text link
Last imported at : Dec. 30, 2021, 7:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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https://jrct.niph.go.jp/latest-detail/jRCTs051210107
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First author
Last imported at : Dec. 30, 2021, 7:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Akifumi Matsuyama
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Contact
Last imported at : Dec. 30, 2021, 7:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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akifumi-matsuyama@umin.ac.jp
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Registration date
Last imported at : Dec. 30, 2021, 7:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2021-10-13
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Recruitment status
Last imported at : May 5, 2022, 11:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not recruiting
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Study design
Last imported at : Dec. 30, 2021, 7:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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RCT
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Allocation
Last imported at : Dec. 30, 2021, 7:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Randomized
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Design
Last imported at : Dec. 30, 2021, 7:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Parallel
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Masking
Last imported at : Dec. 30, 2021, 7:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Open label
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Center
Last imported at : Dec. 30, 2021, 7:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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unclear
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Study aim
Last imported at : Dec. 30, 2021, 7:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Treatment
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Inclusion criteria
Last imported at : Dec. 30, 2021, 7:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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(1) Subjects whose age at the time of obtaining consent is more than 20 years(2) Sex, female(3) quarantine at the hotel(4) Meets all of 1)-3) below1) Subjects whose Asymptomatic/mild case (without respiratory sympton nor dyspnea) has at least one RT-PCR test positive for SARS-CoV-2 from pharyng eal swab, nasopharyng eal swab or saliva.2) Subjects who can gargle3) Subjects who are on the first day of admission to the accommodation treatment facility and plan to perform accommodation treatment for 6 days or more(5) Subjects who have obtained written consent voluntarily to participate in the trial
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Exclusion criteria
Last imported at : Dec. 30, 2021, 7:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Garg ling with sodium lauryl diethylendiaminoglycine before entry
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Number of arms
Last imported at : Dec. 30, 2021, 7:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2
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Funding
Last imported at : Dec. 30, 2021, 7:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Matsuyama Akifumi
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Inclusion age min
Last imported at : Dec. 30, 2021, 7:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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20
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Inclusion age max
Last imported at : Dec. 30, 2021, 7:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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100
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Countries
Last imported at : Dec. 30, 2021, 7:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Japan
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Type of patients
Last imported at : Dec. 30, 2021, 7:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Mild disease at enrollment
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Severity scale
Last imported at : Dec. 30, 2021, 7:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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1: Mild disease at enrollment
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Total sample size
Last imported at : Dec. 30, 2021, 7:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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30
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primary outcome
Last imported at : Dec. 30, 2021, 7:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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The amount of virus excreted from the oral cavity by gargling is measured; and the virus removal effect from the oral cavity by gargling is confirmed. Also; evaluate the difference from water gargling.
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Notes
Last imported at : Dec. 30, 2021, 7:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase
Last imported at : Dec. 30, 2021, 7:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase 1/Phase 2
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Arms
Last imported at : Dec. 30, 2021, 7:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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[{"arm_notes": "", "treatment_id": 2347, "treatment_name": "Sodium lauryl diethylenediaminoglycinate", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
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