Determination the efficacy of the myrtle syrup in the treatment of suspected novel coronavirus pneumonia (COVID-19)
Design
A randomized controlled clinical trial with parallel groups
Settings and conduct
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.
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 Allergy to myrtle, asthma or allergy, hypertension, diabetes, pregnancy/lactation, Congestive heart failure, chronic renal failure, chemotherapy, taking Corticosteroid, immune deficiency do not include.
Intervention groups
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.
Main outcome variables
Respiratory rate; cough (severity and frequency); temperature; weakness; and muscular pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180923041093N3
Registration date:2020-03-28, 1399/01/09
Registration timing:prospective
Last update:2020-03-28, 1399/01/09
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 myrtle (Myrtus Communis) syrup in the treatment of suspected novel coronavirus pneumonia (COVID-19)
Public title
Efficacy of the myrtle syrup 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 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
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
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
2020-02-23, 1398/12/04
Ethics committee reference number
IR.KMU.REC.1399.015
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 admssion
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 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.)
Category
Treatment - Drugs
2
Description
Control group: Patients in this group receive medication according to the novel Corona virus country guideline version 5