| Trial registration number
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CTRI/2020/09/028084 |
Full text link
Last imported at : July 30, 2021, 1:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47137
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First author
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Dr Carolin Elizabeth George
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Contact
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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carolinelizabethj@gmail.com
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Registration date
Last imported at : July 30, 2021, 1:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2020-09-28
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Recruitment status
Last imported at : July 30, 2021, 1:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not recruiting
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Study design
Last imported at : Nov. 18, 2021, 7:33 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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RCT
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Allocation
Last imported at : Nov. 18, 2021, 7:33 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Randomized
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Design
Last imported at : Nov. 18, 2021, 7:33 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Parallel
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Masking
Last imported at : July 30, 2021, 1:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Blind label
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Center
Last imported at : July 30, 2021, 1:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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unclear
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Study aim
Last imported at : July 30, 2021, 1:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Treatment
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Inclusion criteria
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase1: <br/ >. Health care workers or the general public <br/ >. Willing for nasal spray treatment <br/ > <br/ >Phase2: <br/ >Asymptomatic or mild COVID case with a Positive nasopharyngeal swab for SARS-Cov-2 (RT-PCR) not more than two weeks
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Exclusion criteria
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase1: <br/ >Any symptoms suggestive of SARS-Cov-2 <br/ > <br/ > <br/ >Phase2: <br/ > <br/ >. Nasal spray administered less than 12 hours <br/ > before the study <br/ >. active treatment with medications with a <br/ > known side effect of dry mouth <br/ >. current or prior mucosal head and neck <br/ > cancer treatment, <br/ >. acute or chronic upper aerodigestive tract <br/ > infection, <br/ >
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Number of arms
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2
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Funding
Last imported at : July 30, 2021, 1:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Bangalore Baptist Hospital
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Inclusion age min
Last imported at : July 30, 2021, 1:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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6
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Inclusion age max
Last imported at : July 30, 2021, 1:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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60
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Countries
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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India
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Type of patients
Last imported at : July 30, 2021, 1:30 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 : July 30, 2021, 1:30 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 : July 30, 2021, 1:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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80
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primary outcome
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Exhaled bioaerosol count (particles per liter of air)Timepoint: Exhaled bioaerosol count (particles per liter of air)@ 15;30;45 minutes and 1Hr
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Notes
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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| Declared number of arm (2.0)
differs from found arms (3.0)
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Phase
Last imported at : July 30, 2021, 1:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase 2/Phase 3
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Arms
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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[{"arm_notes": "", "treatment_id": 1832, "treatment_name": "Nasal mist calcium salts", "treatment_type": "Nasal spray", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
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