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Trial - IRCT20170903036041N3


Column Value
Trial registration number IRCT20170903036041N3
Full text link
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

First author
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Abbas Motavalian

Contact
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

research@iums.ac.ir

Registration date
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2021-05-23

Recruitment status
Last imported at : Sept. 23, 2021, 3 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Completed

Study design
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

RCT

Allocation
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Randomized

Design
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Parallel

Masking
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Blind label

Center
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

single-center

Study aim
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Treatment

Inclusion criteria
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Confirm patient with clinical feature, laboratory and chest CT scan Having mild decrease level of consiousness, drowsiness to deep coma

Exclusion criteria
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

History of seizure Clinical feature accompanied after drug cosumption Drug side effects

Number of arms
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2

Funding
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Iran University of Medical Sciences

Inclusion age min
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

0

Inclusion age max
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

100

Countries
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Iran

Type of patients
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Critical disease at enrollment

Severity scale
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

8: Critical disease at enrollment

Total sample size
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

60

primary outcome
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Level of consiousnesa Headache Seizure

Notes
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase 2/Phase 3

Arms
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

[{"arm_notes": "", "treatment_id": 810, "treatment_name": "Modafinil", "treatment_type": "Central nervous system agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]