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Trial - IRCT20200408046990N12


Column Value
Trial registration number IRCT20200408046990N12
Full text link
Last imported at : Nov. 21, 2022, 2:41 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

First author
Last imported at : Nov. 21, 2022, 2:41 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Majid Ghayour-mobarhan

Contact
Last imported at : Nov. 21, 2022, 2:41 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

ghayourm@mums.ac.ir

Registration date
Last imported at : Nov. 21, 2022, 2:41 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2022-11-15

Recruitment status
Last imported at : Oct. 25, 2023, 4:13 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Completed

Study design
Last imported at : Nov. 21, 2022, 2:41 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

RCT

Allocation
Last imported at : Nov. 21, 2022, 2:41 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Randomized

Design
Last imported at : Nov. 21, 2022, 2:41 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Parallel

Masking
Last imported at : Nov. 21, 2022, 2:41 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Blind label

Center
Last imported at : Nov. 21, 2022, 2:41 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

multi-center

Study aim
Last imported at : Nov. 21, 2022, 2:41 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Treatment

Inclusion criteria
Last imported at : Nov. 21, 2022, 2:41 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Clinical or laboratory diagnosis of mild to moderate COVID-19 Age between 18-85 y Sign of written consent

Exclusion criteria
Last imported at : Nov. 21, 2022, 2:41 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Pregnancy and lactation History of allergy to melatonin Immunosuppression history Lactase deficiency Concomitant use of alcohol and 1A2 inhibitors

Number of arms
Last imported at : Nov. 21, 2022, 2:41 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2

Funding
Last imported at : Nov. 21, 2022, 2:41 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Mashhad University of Medical Sciences

Inclusion age min
Last imported at : Nov. 21, 2022, 2:41 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

18

Inclusion age max
Last imported at : Nov. 21, 2022, 2:41 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

85

Countries
Last imported at : Nov. 21, 2022, 2:41 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Iran

Type of patients
Last imported at : Nov. 21, 2022, 2:41 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Mild/moderate disease at enrollment

Severity scale
Last imported at : Nov. 21, 2022, 2:41 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2: Mild/moderate disease at enrollment

Total sample size
Last imported at : Nov. 21, 2022, 2:41 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

40

primary outcome
Last imported at : Nov. 21, 2022, 2:41 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Fever Clinical response to the treatment (including improvement of cough, myalgia, headache, olfactory and taste disorders) Radiologic improvement Laboratory response Drug adverse reaction

Notes
Last imported at : Nov. 21, 2022, 2:41 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase
Last imported at : Nov. 21, 2022, 2:41 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase 3

Arms
Last imported at : Nov. 21, 2022, 2:41 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

[{"arm_notes": "", "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"}]