| Trial registration number
|
IRCT20210531051459N1 |
Full text link
Last imported at : Oct. 2, 2021, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
http://en.irct.ir/trial/56744
|
First author
Last imported at : Oct. 2, 2021, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Dr. Mohsen Tafaghodi
|
Contact
Last imported at : Oct. 2, 2021, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
vcresraech@mums.ac.ir
|
Registration date
Last imported at : Oct. 2, 2021, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
2021-10-02
|
Recruitment status
Last imported at : April 25, 2022, 2:03 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Completed
|
Study design
Last imported at : Oct. 2, 2021, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
RCT
|
Allocation
Last imported at : Oct. 2, 2021, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Randomized
|
Design
Last imported at : Oct. 2, 2021, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Parallel
|
Masking
Last imported at : Oct. 2, 2021, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Blind label
|
Center
Last imported at : Oct. 2, 2021, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
single-center
|
Study aim
Last imported at : Oct. 2, 2021, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Treatment
|
Inclusion criteria
Last imported at : Oct. 2, 2021, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Hospitalized patients with definitive diagnosis of Covid 19 using PCR or CT scan
Conscious consent to participate in the study
Age category 18 years and above
|
Exclusion criteria
Last imported at : Oct. 2, 2021, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Acute pancreatitis
Pregnancy and lactation
Having autoimmune diseases and taking immunosuppressants or drugs used to reject transplants
Taking supplements containing probiotics and prebiotics in the last three months
Hospitalization in the ICU
Patients treated with herbal medicines or other traditional medicine methods
Dialysis patients
Having a history of allergies to synbiotics
Dissatisfaction with participating in the study
|
Number of arms
Last imported at : Oct. 2, 2021, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
2
|
Funding
Last imported at : Oct. 2, 2021, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Mashhad University of Medical Sciences
|
Inclusion age min
Last imported at : Oct. 2, 2021, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
18
|
Inclusion age max
Last imported at : Oct. 2, 2021, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
100
|
Countries
Last imported at : Oct. 2, 2021, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Iran
|
Type of patients
Last imported at : Oct. 2, 2021, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Moderate/severe disease at enrollment
|
Severity scale
Last imported at : Oct. 2, 2021, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
4: Moderate/severe disease at enrollment
|
Total sample size
Last imported at : Oct. 2, 2021, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
60
|
primary outcome
Last imported at : Oct. 2, 2021, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
The level of CRP inflammatory marker
The level of IL-6 inflammatory cytokine
ESR level
|
Notes
Last imported at : Oct. 2, 2021, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
|
Phase
Last imported at : Oct. 2, 2021, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Phase 3
|
Arms
Last imported at : Oct. 2, 2021, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
[{"arm_notes": "", "treatment_id": 1940, "treatment_name": "Synbiotics", "treatment_type": "Microbiota intervention", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
|