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General information
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Editing sample size
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اصلاح حجم نمونه
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
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.