Evaluation of the effect of using probiotic products to control the symptoms of hospitalized patients with definite diagnosis of COVID-19
Design
Phase 3 trial, Randomized trial, with block randomization on 60 covid-19 patients, in two groups control and intervention, follow for 14 days.
Settings and conduct
Firoozabadi hospital, after infectious disease specialist visit and definite diagnosis of covid19, with block randomization, divided two groups, intervention and control then prebiotic will take to intervention patient.
Participants/Inclusion and exclusion criteria
Inclusion criteria: definite Covid19 patients; individual satisfaction.
Exclusion criteria: pregnancy and breastfeeding; ICU admission; using herbal remedies; chemotherapy.
Intervention groups
Intervention group: standard therapy plus prebiotic.
Control group: standard therapy.
Main outcome variables
Evaluation of Prebiotic on Covid19; fever; cough; respiratory rate; weakness; myalgia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161206031255N4
Registration date:2020-12-07, 1399/09/17
Registration timing:registered_while_recruiting
Last update:2020-12-07, 1399/09/17
Update count:0
Registration date
2020-12-07, 1399/09/17
Registrant information
Name
Elham Akhtari
Name of organization / entity
Iran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 320 4006
Email address
akhtari.e@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2021-01-19, 1399/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of probiotic use on control of sign and symptoms of admitted patients with covid-19
Public title
ٍEfficacy of prebiotic products on admitted patients with Covid-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent
positive PCR or positive CT-scan
Exclusion criteria:
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
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Initially, before starting the sampling, the row number from 1 to 60 is considered for all patients. Then, with the software SPSS, half of the numbers are randomly given to the patient group and the other half to the control. As soon as the patient enters the study, the row number is considered in the list in the order of entry. Grouping was done based on predetermined numbers.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic's commitee of Beheshti university of Medical Sciences
Intervention group: Patients take standard medicine hydroxychlroquine and remdecevir. prebiotic powder 150 mg in the pack that 3 mg per dose for three times a day for 2 weeks.
Category
Treatment - Drugs
2
Description
Control group: hydroxychlroquin and remdecevir as standard treatment.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Firoozabadi hospital
Full name of responsible person
Roshanak Mokaberinejad
Street address
Firoozabadi hospital, Fadaeian eslam street, Rey town, Tehran, Iran