Determining the effect of Echinacea syrup on the symptoms of lower respiratory infections in patients with COVID-19
Design
A randomized controlled trial with parallel groups, single-blind, phase 3 on 66 patients. Random numbers method and reading numbers from left to right are used for randomization. A sealed envelope is used to conceal the intervention and control groups.
Settings and conduct
This study was performed in the inpatient wards of Covid-19 patients. All patients who have been definitively diagnosed with Covid-19 by a positive PCR test and who do not have symptoms of lower respiratory infections based on lung imaging, tests, and clinical examinations participate in this study. The intervention group receives Echinacea syrup during the treatment period in the hospital. Data analyzer are kept blind to the information of study groups. The control group receives the usual treatment. Using analytical statistical tests, the effect of treatment results with Echinacea syrup is evaluated.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Definitive diagnosis of Covid's disease 19, willingness to participate, evidence of symptoms of lower respiratory infections;
Exclusion criteria: underlying diseases such as COPD, chest deformity
Intervention groups
In the intervention group, the treatment is performed three times a day for three days with 5 cc of Echinacea syrup made by Kimia Daroo factory affiliated to Astan Quds Razavi.
In the control group, treatment is performed according to routine inpatient protocols.
Main outcome variables
Symptoms of infection of the lower respiratory tract
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130522013423N2
Registration date:2022-05-18, 1401/02/28
Registration timing:registered_while_recruiting
Last update:2022-05-18, 1401/02/28
Update count:0
Registration date
2022-05-18, 1401/02/28
Registrant information
Name
Seyed-Mousa mahdizadeh
Name of organization / entity
Faculty of nursing&midwifery mashhad university of medical scienceses
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1511
Email address
mahdizadehm@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-15, 1401/02/25
Expected recruitment end date
2022-10-22, 1401/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Echinacea syrup on outcome in lower respiratory infections in patients with covid-19
Public title
Evaluation of the effect of Echinacea syrup on outcome in lower of respiratory infections of COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of Covid 19
Willingness to participate
Evidence of symptoms of lower respiratory infections
Exclusion criteria:
Having underlying diseases such as COPD
deformity in the chest
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Data analyser
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a table of random numbers is used for randomization. Numbers are read from left to right. The randomization unit is also individual. For concealment, opaque sealed envelopes with random sequences are used. At the time of sample selection, an envelope is assigned to each patient. Even numbers are considered for the intervention group and odd numbers for the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this single-blind study, data analyzer are blinded to the information of intervention and control groups by assigning an unspecified title (for example, groups 1 and 3).
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences Ethics
Street address
NO 2, Daneshgah St, Mashhad University of Medical Sciences.
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Approval date
2022-04-09, 1401/01/20
Ethics committee reference number
IR.MUMS.REC.1401.013
Health conditions studied
1
Description of health condition studied
Covid-19
ICD-10 code
U10.9
ICD-10 code description
Multisystem inflammatory syndrome associated with COVID-19, unspecified
Primary outcomes
1
Description
Symptoms of the infection in the lower respiratory tract
Timepoint
Before and after hospitalization
Method of measurement
Procalcitonin test, chest x-ray
Secondary outcomes
1
Description
Duration of hospitalization
Timepoint
After discharge
Method of measurement
Determining hospitalization days using patient record
2
Description
Re-hospitalization
Timepoint
After discharge
Method of measurement
Number of readmission times
Intervention groups
1
Description
Intervention group: In addition to applying the routine approaches of the inpatient ward, 5 cc of Echinasea syrup, which is a herbal medicine made by Kimia Daroo factory affiliated to Astan Quds Razavi, will be used three times a day for 3 days in the hospital.
Category
Treatment - Drugs
2
Description
Control group: this group receives treatment and care based on routine ward protocols.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Seyed-Mousa Mahdizadeh
Street address
Imam Reza Research and Treatment Center, No 7, Ibne-Sina St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3854 3031
Email
mahdizadehm@mums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayour Mobarhan
Street address
Mahshhad University of Medical Sciences, Daneshgah St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
GhayourM@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyed-Mousa Mahdizadeh
Position
َAssistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and midwifery, Ebne-sina St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
Email
mahdizadehm@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyed Mousa Mahdizadeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery,Ebne-Sina St.
City
Mashhad
Province
Razavi Khorasan
Postal code
989137913199+
Phone
+98 513591511
Email
mahdizadehm@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyed-Mousa Mahdizadeh
Position
Asisstant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty Of Nursing and midwifery,Ebne-Sina St.
City
Mashhad
Province
Razavi Khorasan
Postal code
989137913199+
Phone
+98 51338591511
Email
mahdizadehtm@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available