Protocol summary
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Study aim
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Determination the efficacy of barley-based remedy in the treatment of suspected novel coronavirus pneumonia (COVID-19)
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Design
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A randomized controlled clinical trial with parallel groups
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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
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Main outcome variables
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clinical status
General information
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Reason for update
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Editing sample size
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Acronym
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IRCT registration information
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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
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Registration date
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2020-03-28, 1399/01/09
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-04-02, 1399/01/14
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Expected recruitment end date
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2020-05-03, 1399/02/14
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Efficacy of the barley-based remedy in the treatment of suspected novel coronavirus (COVID-19) pneumonia
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Public title
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Efficacy of the barley-based remedy in the treatment of novel corona
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
70
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-02-22, 1398/12/03
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Ethics committee reference number
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IR.KMU.REC.1399.014
Health conditions studied
1
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Description of health condition studied
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COVID-19
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ICD-10 code
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U07.1
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ICD-10 code description
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COVID-19
Primary outcomes
1
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Description
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Temperature
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Timepoint
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0-1-2-3-4-7-14 days after starting intervention
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Method of measurement
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Termometer
2
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Description
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Cough (severity-frequency)
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Timepoint
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0-1-2-3-4-7-14 days after starting intervention
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Method of measurement
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Fisman Cough Severity Score
3
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Description
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Weakness
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Timepoint
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0-1-2-3-4-7-14 days after starting intervention
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Method of measurement
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Asking patients using visual analog scale (VAS)
4
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Description
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Muscular pain
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Timepoint
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0-1-2-3-4-7-14 days after starting intervention
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Method of measurement
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Asking patients using visual analog scale (VAS)
5
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Description
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Respiratory rate
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Timepoint
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0-1-2-3-4-7-14 days after starting intervention
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Method of measurement
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Counting the number of breaths per minute
Secondary outcomes
1
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Description
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Hospital admission
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Timepoint
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0-1-2-3-4-7-14 days after starting intervention
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Method of measurement
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Ratio of the number of admission to total patients in each group
2
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Description
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Mortality
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Timepoint
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0-1-2-3-4-7-14 days after starting intervention
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Method of measurement
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Ratio of the number of deaths to total patients in each group
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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Control group: Patients in this group receive medication according to the Ministry of Health protocol.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kerman University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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After the completion of the study, the information on the main outcome will be shared
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When the data will become available and for how long
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10 months after printing
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To whom data/document is available
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All researchers can take action
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Under which criteria data/document could be used
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Data and results will be available to all researchers for research on diabetes
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From where data/document is obtainable
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dr.azimm@gmail.com
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What processes are involved for a request to access data/document
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The data will be provided to the applicant after a review and approval of the request within a month
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Comments
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