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Trial - IRCT20210203050233N1


Column Value
Trial registration number IRCT20210203050233N1
Full text link
Last imported at : April 15, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

First author
Last imported at : April 15, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Dr. Reza Malekzadeh

Contact
Last imported at : April 15, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

NIMAD@RESEARCH.AC.IR

Registration date
Last imported at : April 15, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2021-04-14

Recruitment status
Last imported at : June 22, 2021, 1:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Completed

Study design
Last imported at : April 15, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

RCT

Allocation
Last imported at : April 15, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Randomized

Design
Last imported at : April 15, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Parallel

Masking
Last imported at : April 15, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Blind label

Center
Last imported at : April 15, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

single-center

Study aim
Last imported at : April 15, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Treatment

Inclusion criteria
Last imported at : April 15, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

1. Confirmed cases of Covid-19 2. Patients admitted to hospital Covid-19 general wards 3. Being 20-60 years old, of either sex. 4. Ability to sallow oral medication. 5. Patients without immunodeficiency and gastrointestinal disorders 6. Not being pregnant/breast feeding

Exclusion criteria
Last imported at : April 15, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

1. Being allergic to saffron/crocin 2. Inability to swallow oral medication during admission

Number of arms
Last imported at : April 15, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2

Funding
Last imported at : April 15, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

National Institute for Medical Research Development (NIMAD)

Inclusion age min
Last imported at : April 15, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

20

Inclusion age max
Last imported at : April 15, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

60

Countries
Last imported at : April 15, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Iran

Type of patients
Last imported at : April 15, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Moderate/severe disease at enrollment

Severity scale
Last imported at : April 15, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

4: Moderate/severe disease at enrollment

Total sample size
Last imported at : April 15, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

60

primary outcome
Last imported at : April 15, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Cell blood count (CBC) serum C-reactive protein (CRP) level TNF-α serum level LDH serum level Erythrocyte sedimentation rate (ESR)

Notes
Last imported at : April 15, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase
Last imported at : April 15, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase 3

Arms
Last imported at : April 15, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

[{"arm_notes": "", "treatment_id": 356, "treatment_name": "Crocin", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]