Investigating the efficacy and safety of herbal Myrtus inhalation spray in controlling the symptoms of patients with mild COVID-19
Design
This study is a single-center, prospective, randomized, open-labeled, controlled, parallel phase 3 clinical trial.
Settings and conduct
Outpatients with mild Qovid-19 referred to Baqiyatallah Hospital who are eligible for the study are randomly divided into intervention and control groups and are treated.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Age: equal or more than 18 years; The patient have written consciously and freely consent to participate in the study; The patient's clinical symptoms (dry cough, shortness of breath, fever) confirm COVID-19; Confirmed diagnosis of COVID-19, with RT-PCR confirmation; Less than 7 days have passed since the onset of symptoms.
Exclusion criteria: History of allergy to this nasal spray ingredients; The patient is in another clinical trial at the same time; The patient needs to receive medical care from the inpatient care; Pregnancy; Lactation.
Intervention groups
Intervention group: Myrtus inhalation spray 1 puff every 12 hours, for 14 days (In addition to routine treatment according to the latest national guideline for the treatment of new corona-virus). Control group: routine treatment according to the latest national guideline for the treatment of new corona-virus
Investigating the efficacy and safety of herbal Myrtus inhalation spray in controlling the symptoms of patients with mild COVID-19
Public title
Investigating the efficacy and safety of Myrtus inhalation spray in controlling the symptoms of patients with mild COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age: equal or more than 18 years;
The patient have written consciously and freely consent to participate in the study;
The patient's clinical symptoms (dry cough, shortness of breath, fever) confirm COVID-19.
Confirmed diagnosis of COVID-19, with RT-PCR confirmation.
Less than 7 days have passed since the onset of symptoms.
Exclusion criteria:
History of allergy to this nasal spray ingredients;
The patient is in another clinical trial at the same time;
The patient needs to receive medical care from the inpatient care;
Pregnancy;
Lactation.
Age
From 18 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
Block Randomization method is used to randomized the patients.
For randomization, we visited the www.sealedenvelope.com, then randomization tab and make a list option were selected, the number of intervention groups, sample size, block size (which was selected due to the small sample size, 4 )were entered the intended locations, then a random list containing the pattern of patient allocation was obtained in two intervention.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This study is a single-center, prospective, randomized, open-labeled, controlled, parallel phase 3 clinical trial.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Baqiyatallah University of Medical Science
Street address
Baqiyatallah University of Medical Science, south Sheikh-Bahaei St., Mollasadra St., Vanak Sq., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2020-05-09, 1399/02/20
Ethics committee reference number
IR.BMSU.REC.1399.159
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
Clinical symptoms (dry cough)
Timepoint
Baseline (before the initiation of intervention), and day 7 from the initiation
Method of measurement
Physical examination,questionnaire
2
Description
Clinical symptoms (respiratory distress)
Timepoint
Baseline (before the initiation of intervention), and day 7 from the initiation.
Method of measurement
Pulse-oxymetery device
3
Description
Clinical symptoms (fever)
Timepoint
Baseline (before the initiation of intervention), and day 7 from the initiation
Method of measurement
Thermometer
Secondary outcomes
1
Description
Side effects
Timepoint
Before the intervention initiation (baseline) and day 7
Method of measurement
Physical examination
2
Description
Need to be hospitalized
Timepoint
Before the intervention initiation (baseline) and day 7
Method of measurement
Question from the patient
3
Description
Mortality
Timepoint
Day 28 from the initiation
Method of measurement
Clinical assessment
Intervention groups
1
Description
Intervention group: Myrtus inhalation spray 1 puff every 12 hours, for 14 days (In addition to routine treatment according to the latest national guideline for the treatment of new corona-virus)
Category
Treatment - Drugs
2
Description
Control group: Routine treatment according to the latest national guideline for the treatment of new corona-virus.