Protocol summary
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Study aim
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Determination the efficacy of the myrtle syrup 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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Eligible patients with mild to moderate disease according to Fifth Edition of the Novel Corona Virus Guidelines who visit the clinics designated by the Kerman department of Health for Covid-19, and candidate for quarantine and receive home treatment will enter to the study.
Patients in both groups receive classical medicine according to the Fifth Edition of the Novel Corona Virus Guidelines. Patients in the intervention group receive myrtle syrup as well as classical medicine.
Clinical status of the patients will be assess 0-1-2-3-4-7-14 days after intervention.
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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 Allergy to myrtle, asthma or allergy, hypertension, diabetes, pregnancy/lactation, Congestive heart failure, 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 Fifth Edition of the Novel Corona Virus Guidelines with myrtle syrup for 5 days (Patients daily boil the contents of a pack containing 10 grams of myrtle fruit and 10 grams of sugar in 3 glasses of water gently to stay 2 glasses, then smooth it and drink one glass in the morning and one glass in the evening. )
Control group: receive medication for treatment of Covid-19 according to Fifth Edition of the Novel Corona Virus Guidelines.
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Main outcome variables
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Respiratory rate; cough (severity and frequency); temperature; weakness; and muscular pain
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:
IRCT20180923041093N3
Registration date:
2020-03-28, 1399/01/09
Registration timing:
prospective
Last update:
2020-06-03, 1399/03/14
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 myrtle (Myrtus Communis) syrup in the treatment of suspected novel coronavirus pneumonia (COVID-19)
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Public title
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Efficacy of the myrtle syrup 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 Fifth Edition of the Novel Corona Virus Guidelines
Candidate for outpatient treatment
Exclusion criteria:
Allergy to myrtle
Asthma or allergy
Hypertension
Diabetes
Pregnancy/lactation
Congestive heart failure
Chronic renal failure
Chemotherapy
Taking 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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3
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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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2020-02-23, 1398/12/04
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Ethics committee reference number
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IR.KMU.REC.1399.015
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 admssion
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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 medication for treatment of Covid-19 based on Fifth Edition of the Novel Corona Virus Guidelines, in addition they recieve myrtle syrup for 5 days (Patients daily boil the contents of a pack containing 10 grams of myrtle fruit and 10 grams of sugar in 3 glasses of water gently to stay 2 glasses, then smooth it and drink one glass in the morning and one 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 novel Corona virus country guideline version 5
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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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