| Trial registration number
|
CTRI/2021/12/038630 |
Full text link
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)
|
http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=63244
|
First author
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)
|
Dr Vijay Kumar
|
Contact
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)
|
vijay.bmc.ccm@gmail.com
|
Registration date
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)
|
2021-12-15
|
Recruitment status
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)
|
Not recruiting
|
Study design
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)
|
RCT
|
Allocation
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)
|
Randomized
|
Design
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)
|
Parallel
|
Masking
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)
|
Blind label
|
Center
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)
|
single-center
|
Study aim
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)
|
Treatment
|
Inclusion criteria
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)
|
RTPCR / CT proven COVID-19 pneumonia with saturation less than 93%.
|
Exclusion criteria
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)
|
Post cardiac arrest <br/ >
Patients on opioid antagonist, chronic opioid or sleeping pills, SSRI, Monoamine oxidase inhibitors, central nervous system depressants <br/ >
Patients with cerebrovascular accident and other CNS disorders.
|
Number of arms
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)
|
3
|
Funding
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)
|
Dr Suhasini Hubli
|
Inclusion age min
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)
|
18
|
Inclusion age max
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)
|
70
|
Countries
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)
|
India
|
Type of patients
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)
|
Severe disease at enrollment
|
Severity scale
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)
|
6: Severe disease at enrollment
|
Total sample size
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)
|
140
|
primary outcome
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)
|
To study the effect of melatonin on incidence of onset of delirium on day 3 of delirium <br/ >Timepoint: Day 3rd of icu <br/ >
|
Notes
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)
|
| Declared number of arm (2.0)
differs from found arms (3.0)
|
Phase
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)
|
Phase 4
|
Arms
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)
|
[{"arm_notes": "3 mg", "treatment_id": 779, "treatment_name": "Melatonin", "treatment_type": "Central nervous system agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "6 mg", "treatment_id": 779, "treatment_name": "Melatonin", "treatment_type": "Central nervous system agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
|