| Trial registration number
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CTRI/2021/05/033544 |
Full text link
Last imported at : May 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55941
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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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Ramarathnam Krishna Kumar
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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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ravidoc55@yahoo.co.in
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Registration date
Last imported at : May 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2021-05-11
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Recruitment status
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Recruiting
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Study design
Last imported at : May 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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RCT
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Allocation
Last imported at : May 27, 2021, 12:45 a.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 : May 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Open label
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Center
Last imported at : May 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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single-center
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Study aim
Last imported at : May 27, 2021, 12:45 a.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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Age between 20 to 90 years <br/ > <br/ >RT â?? PCR Positive <br/ > <br/ >Hospitalised patients <br/ > <br/ >The case criteria for the study â?? Renal Function Test and Liver Functional Test should be normal at the screening, Oxygen saturation should be 95% or more <br/ >
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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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Hypersensitivity/Allergy to Drug <br/ >Gastritis <br/ >Recent Heart attack <br/ >Severe Asthma <br/ >Acute Kidney Injury. <br/ >Patients on immune suppressants <br/ >â?¢ To Exclude pregnant and lactating mothers <br/ >â?¢ Specify NSAID/Indomethacin allergy <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 : May 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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IIT Madras
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Inclusion age min
Last imported at : May 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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20
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Inclusion age max
Last imported at : May 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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90
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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 : May 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Moderate/severe disease at enrollment
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Severity scale
Last imported at : May 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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4: Moderate/severe disease at enrollment
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Total sample size
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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300
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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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Reduction in Covid-19 symptoms and the intervention is expected to be beneficial in reducing the Covid 19 symptoms than the comparatorTimepoint: Day 0 screening <br/ >Day 1 to 5 drug administration <br/ >Day 7 end of study
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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 : May 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase 2
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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": 649, "treatment_name": "Indomethacin", "treatment_type": "Non-steroidal anti-inflammatory", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 958, "treatment_name": "Paracetamol", "treatment_type": "Central nervous system agents", "pharmacological_treatment": "Pharmacological treatment"}]
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