| Trial registration number
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CTRI/2021/03/031720 |
Full text link
Last imported at : March 26, 2021, 2:21 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=53161
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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 Mehdi Ali Mirza
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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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drrajivb85@gmail.com
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Registration date
Last imported at : March 26, 2021, 2:21 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2021-03-04
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Recruitment status
Last imported at : March 26, 2021, 2:21 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not recruiting
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Study design
Last imported at : March 26, 2021, 2:21 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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RCT
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Allocation
Last imported at : March 26, 2021, 2:21 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Randomized
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Design
Last imported at : March 26, 2021, 2:21 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Parallel
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Masking
Last imported at : March 26, 2021, 2:21 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Blind label
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Center
Last imported at : March 26, 2021, 2:21 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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single-center
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Study aim
Last imported at : March 26, 2021, 2:21 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)
|
1. Patients of either gender, diagnosed to <br/ > be COVID-19 positive through RTPCR <br/ > method. <br/ >2. Patients presenting with moderate <br/ > symptoms. <br/ >3. Patients of age more than 18 years. <br/ >4. Willing to comply with study related <br/ > procedures. <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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1. Known history of hypersensitivity or <br/ > allergy to probiotics <br/ >2. Pregnant or lactating woman <br/ >3. Patients with mild and severe infections, <br/ > critically ill patients. <br/ >4. HIV or HBsAg positive <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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3
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Funding
Last imported at : March 26, 2021, 2:21 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Dr Mehdi Ali Mirza
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Inclusion age min
Last imported at : March 26, 2021, 2:21 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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18
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Inclusion age max
Last imported at : March 26, 2021, 2:21 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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80
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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 : March 26, 2021, 2:21 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Mild/moderate disease at enrollment
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Severity scale
Last imported at : March 26, 2021, 2:21 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2: Mild/moderate disease at enrollment
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Total sample size
Last imported at : March 26, 2021, 2:21 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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90
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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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1. Time to Clinical <br/ > recovery after <br/ > hospitalization <br/ >2. Improvement in <br/ > inflammatory; immune <br/ > and clinical <br/ > parameters <br/ >3. Proportion of <br/ > patients recovering <br/ > in each group <br/ >Timepoint: Clinical parameter- day1 to day 14 <br/ >laboratory parameters- day 1;3;7;14 respectively.
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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 (3.0)
differs from found arms (4.0)
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Phase
Last imported at : March 26, 2021, 2:21 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not reported
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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": 169, "treatment_name": "Bacillus clausii", "treatment_type": "Microbiota intervention", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 170, "treatment_name": "Bacillus coagulans", "treatment_type": "Microbiota intervention", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
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