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Trial - IRCT20161206031255N4


Column Value
Trial registration number IRCT20161206031255N4
Full text link
Last imported at : Dec. 8, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

First author
Last imported at : Dec. 8, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Afshin Zerghi

Contact
Last imported at : Dec. 8, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

mpajouhesh@sbmu.ac.ir

Registration date
Last imported at : Dec. 8, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2020-12-07

Recruitment status
Last imported at : Jan. 19, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Completed

Study design
Last imported at : Dec. 8, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

RCT

Allocation
Last imported at : Dec. 8, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Randomized

Design
Last imported at : Dec. 8, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Parallel

Masking
Last imported at : Dec. 8, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Open label

Center
Last imported at : Dec. 8, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

single-center

Study aim
Last imported at : Dec. 8, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Treatment

Inclusion criteria
Last imported at : Dec. 8, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Informed consent positive PCR or positive CT-scan

Exclusion criteria
Last imported at : Dec. 8, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Patient's unwillingness to participate Dialysis patients ICU admitted or intubated patients Pregnancy orbreast feeding use of steroid or immunosupressive medicatns use of the other herbal medications

Number of arms
Last imported at : Dec. 8, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2

Funding
Last imported at : Dec. 8, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Shahid Beheshti University of Medical Sciences

Inclusion age min
Last imported at : Dec. 8, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

0

Inclusion age max
Last imported at : Dec. 8, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

100

Countries
Last imported at : Dec. 8, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Iran

Type of patients
Last imported at : Dec. 8, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Moderate/severe disease at enrollment

Severity scale
Last imported at : Dec. 8, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

4: Moderate/severe disease at enrollment

Total sample size
Last imported at : Dec. 8, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

60

primary outcome
Last imported at : Dec. 8, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

cough Breath rate fever weakness myalgia C reactive protein Lymphocyte blood Oxygen saturation Diarrhea

Notes
Last imported at : Dec. 8, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase
Last imported at : Dec. 8, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase 3

Arms
Last imported at : Dec. 8, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

[{"arm_notes": "", "treatment_id": 1022, "treatment_name": "Probiotics", "treatment_type": "Microbiota intervention", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]