Protocol summary
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Study aim
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Investigating the efficacy and safety of herbal Myrtus nasal spray in controlling the symptoms of patients with mild COVID-19
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Design
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This study is a single-center, prospective, randomized, open-labeled, controlled, parallel phase 3 clinical trial.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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Intervention group: Myrtus nasal spray 1 puff into each nostrile every 8 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
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Main outcome variables
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Clinical symptoms changes (dry cough, respiratory distress, fever)
General information
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Reason for update
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Correction of dose (from BD to TDS) and dosage form (from inhalation spray to nasal spray)
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20080901001165N63
Registration date:
2020-10-22, 1399/08/01
Registration timing:
retrospective
Last update:
2020-10-26, 1399/08/05
Update count:
1
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Registration date
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2020-10-22, 1399/08/01
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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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2020-07-22, 1399/05/01
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Expected recruitment end date
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2020-09-21, 1399/06/31
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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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Investigating the efficacy and safety of herbal Myrtus nasal spray in controlling the symptoms of patients with mild COVID-19
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Public title
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Investigating the efficacy and safety of Myrtus nasal spray in controlling the symptoms of patients with mild COVID-19
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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.
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Age
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From 18 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:
100
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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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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This study is a single-center, prospective, randomized, open-labeled, controlled, parallel phase 3 clinical trial.
Ethics committees
1
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Ethics committee
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Approval date
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2020-05-09, 1399/02/20
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Ethics committee reference number
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IR.BMSU.REC.1399.159
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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Clinical symptoms (dry cough)
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Timepoint
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Baseline (before the initiation of intervention), and day 7 from the initiation
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Method of measurement
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Physical examination,questionnaire
2
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Description
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Clinical symptoms (respiratory distress)
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Timepoint
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Baseline (before the initiation of intervention), and day 7 from the initiation.
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Method of measurement
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Pulse-oxymetery device
3
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Description
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Clinical symptoms (fever)
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Timepoint
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Baseline (before the initiation of intervention), and day 7 from the initiation
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Method of measurement
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Thermometer
Secondary outcomes
1
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Description
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Side effects
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Timepoint
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Before the intervention initiation (baseline) and day 7
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Method of measurement
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Physical examination
2
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Description
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Need to be hospitalized
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Timepoint
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Before the intervention initiation (baseline) and day 7
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Method of measurement
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Question from the patient
3
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Description
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Mortality
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Timepoint
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Day 28 from the initiation
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Method of measurement
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Clinical assessment
Intervention groups
1
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Description
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Intervention group: Myrtus nasal spray 1 puff into each nostril every 8 hours, for 14 days (In addition to routine treatment according to the latest national guideline for the treatment of new corona-virus)
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Category
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Treatment - Drugs
2
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Description
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Control group: Routine treatment according to the latest national guideline for the treatment of new corona-virus.
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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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Bagheiat-allah 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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be 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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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be 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