History
# Registration date Revision Id
2 2020-06-03, 1399/03/14 137691
1 2020-03-28, 1399/01/09 127058
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  • General information

    100
    70
    empty
    Editing sample size
    empty
    اصلاح حجم نمونه

Protocol summary

Study aim
Determination the efficacy of barley-based remedy in the treatment of suspected novel coronavirus pneumonia (COVID-19)
Design
A randomized controlled clinical trial with parallel groups
Settings and conduct
Patients with mild to moderate disease who visit the clinics designated by the Department of Health for Covid-19, are a quarantine candidate and receive home treatment.
Participants/Inclusion and exclusion criteria
patients with 18-65 years old, developing mild to moderate COVID-19 based on Ministry of Health protocol and candidate for outpatient treatment include to this study and those with asthma or allergy, hypertension, diabetes, pregnancy/lactation, CHF, chronic renal failure, chemotherapy, taking Corticosteroid, immune deficiency do not include.
Intervention groups
Intervention group: Receiving medication for treatment of Covid-19 based on Ministry of Health protocol with barley based-compound Control group: receive medication for treatment of Covid-19 according to Ministry of Health protocol
Main outcome variables
clinical status

General information

Reason for update
Editing sample size
Acronym
IRCT registration information
IRCT registration number: IRCT20180923041093N4
Registration date: 2020-03-28, 1399/01/09
Registration timing: prospective

Last update: 2020-06-06, 1399/03/17
Update count: 1
Registration date
2020-03-28, 1399/01/09
Registrant information
Name
Fatemeh sadat Hasheminasab
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5333 8547
Email address
hashemifa67@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-02, 1399/01/14
Expected recruitment end date
2020-05-03, 1399/02/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of the barley-based remedy in the treatment of suspected novel coronavirus (COVID-19) pneumonia
Public title
Efficacy of the barley-based remedy in the treatment of novel corona
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18-65 years old Developed mild to moderate COVID-19 based on Ministry of Health protocol Candidate for outpatient treatment
Exclusion criteria:
Asthma or allergy Hypertension Diabetes Pregnancy/lactation CHF Chronic renal failure ChemotherapyT aking Corticosteroid Immune deficiency
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be selected according to the inclusion criteria and then randomly assigned to the experimental and control groups according to the random sequence obtained through random allocation software.
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
Ethics committee of Kerman University of Medical Sciences
Street address
Beginning of Ibn Sina Street, Beginning of Jihad Blvd., Somayeh Road (Tahmasebabad), Kerman
City
Kerman
Province
Kerman
Postal code
584-76175
Approval date
2020-02-22, 1398/12/03
Ethics committee reference number
IR.KMU.REC.1399.014

Health conditions studied

1

Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19

Primary outcomes

1

Description
Temperature
Timepoint
0-1-2-3-4-7-14 days after starting intervention
Method of measurement
Termometer

2

Description
Cough (severity-frequency)
Timepoint
0-1-2-3-4-7-14 days after starting intervention
Method of measurement
Fisman Cough Severity Score

3

Description
Weakness
Timepoint
0-1-2-3-4-7-14 days after starting intervention
Method of measurement
Asking patients using visual analog scale (VAS)

4

Description
Muscular pain
Timepoint
0-1-2-3-4-7-14 days after starting intervention
Method of measurement
Asking patients using visual analog scale (VAS)

5

Description
Respiratory rate
Timepoint
0-1-2-3-4-7-14 days after starting intervention
Method of measurement
Counting the number of breaths per minute

Secondary outcomes

1

Description
Hospital admission
Timepoint
0-1-2-3-4-7-14 days after starting intervention
Method of measurement
Ratio of the number of admission to total patients in each group

2

Description
Mortality
Timepoint
0-1-2-3-4-7-14 days after starting intervention
Method of measurement
Ratio of the number of deaths to total patients in each group

Intervention groups

1

Description
Intervention group: Patients in this group receive the treatment according to the protocol of the Ministry of Health, in addition they should daily boil the contents of one drug pack with 8 glasses of water slowly to stay two glasses, then smooth and the content of the sachet will be added for 5 days. They drink a glass in the morning and a glass in the evening.
Category
Treatment - Drugs

2

Description
Control group: Patients in this group receive medication according to the Ministry of Health protocol.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Afzalipour Hospital
Full name of responsible person
Maryam Azimi
Street address
AfzaliPour Hospital, Adjacent to Bahonar University, AfzaliPour Landscape, Imam highway, Kerman
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3132 8000
Fax
+98 34 1211 3426
Email
dr.azimm@gmail.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhti
Street address
Kerman university of medical sciences, Haft-Bagh Highway
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3226 3855
Fax
+98 34 3226 3857
Email
abpardakhty@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Maryam Azimi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Crossroad Amir kabir, Jomhuri eslami Blvd
City
Kerman
Province
Kerman
Postal code
7618843883
Phone
+98 34 3211 0860
Email
dr.azimm@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Maryam Azimi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Crossroad Amir kabir, Jomhuri eslami Blvd
City
Kerman
Province
Kerman
Postal code
7618843883
Phone
+98 34 3211 0860
Email
dr.azimm@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Maryam Azimi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Crossroad Amir kabir, jomhuri eslami Blvd
City
Kerman
Province
Kerman
Postal code
7618843883
Phone
+98 34 3211 0860
Email
dr.azimm@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
After the completion of the study, the information on the main outcome will be shared
When the data will become available and for how long
10 months after printing
To whom data/document is available
All researchers can take action
Under which criteria data/document could be used
Data and results will be available to all researchers for research on diabetes
From where data/document is obtainable
dr.azimm@gmail.com
What processes are involved for a request to access data/document
The data will be provided to the applicant after a review and approval of the request within a month
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