Comparison of the effect of marshmallow and eucalyptus nebulizer on cough intensity among patients with COVID-19 disease
Design
Three-group, randomized, phase two clinical trial on 45 patients.
First, the available samples are selected and then people will be randomly divided into three groups: intervention 1, intervention 2 and control.
Settings and conduct
The place of the study: COVID-19 Patients' ward in Allameh Behlool Gonabadi Hospital; Patients: who is affected by COVID-19 disease in Respiratory Phase; There is no blinding in the study
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Willingness to participate in the study;
Hospitalized in COVID-19 ward of Allameh Behlool Gonabadi Hospital;
Definite COVID-19 disease (PCR test positive);
Cough and approval by the treating physician;
Having almost similar cardex by all patients;
Being in the respiratory phase of the disease،
Criteria for not entering:
Have a history of allergies to any herbal medicine;
Having a history of underlying respiratory disease;
Having an underlying disease that causes a reaction to herbal medicines
Intervention groups
Intervention group 1: Marshmallow nebulizer 40 mg equivalent to 1 cc with 5 cc of normal saline for 15 minutes once a day with a special nebulizer mask;
Intervention group 2: Eucalyptus plant nebulizer 2% (pure eucalyptus globulus product of Zardband company) 4 cc in 5 cc of normal saline for 15 minutes once a day with a special nebulizer mask;
The control group performed routine interventions.
Main outcome variables
Cough intensity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190622043968N2
Registration date:2021-12-29, 1400/10/08
Registration timing:registered_while_recruiting
Last update:2021-12-29, 1400/10/08
Update count:0
Registration date
2021-12-29, 1400/10/08
Registrant information
Name
Maryam Moradi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5652 5792
Email address
moradi.mf69@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2022-03-15, 1400/12/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of marshmallow and eucalyptus nebulizer on cough intensity among patients with COVID-19 disease
Public title
The effect of marshmallow and eucalyptus nebulizer on cough intensity in patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study
Hospitalized in COVID-19 ward of Allameh Behlool Gonabadi Hospital
Definite COVID-19 disease (PCR test positive)
Cough and approval by the treating physician
Having almost similar cardex by all patients
Being in the respiratory phase of the disease
Exclusion criteria:
Having a history of allergy to any herbal medicine
Having a history of underlying respiratory disease
Having an underlying disease that causes a reaction to herbal medicines
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be selected from patients admitted to Covid ward by available sampling and assigned to three groups of intervention (A), intervention (B) and control group (C) by block randomized randomization method (numerical six blocks).
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients participating in the study will not know about the intervention group and the drug used.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Gonabad University of Medical Sciences
Street address
Research Center for Social Determinants of Health, Gonabad University of Medical Sciences, Next to the Asian Road
City
Gonabad
Province
Razavi Khorasan
Postal code
۹۶۹۱۷۹۳۷۱۸
Approval date
2021-10-23, 1400/08/01
Ethics committee reference number
IR.GMU.REC.1400.095
Health conditions studied
1
Description of health condition studied
Cough intensity in patients with COVID-19 disease
ICD-10 code
R05
ICD-10 code description
Cough
Primary outcomes
1
Description
Severity of cough in patients with COVID-19 disease
Timepoint
Before the intervention, then once a day for two hours after the intervention until the end of the hospitalization period
Method of measurement
Counting the number of coughs based on Visual Analogue Scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Marshmallow, Marshmallow nebulizer 40 mg equivalent to 1 cc with 5 cc of normal saline for 15 minutes with a special nebulizer mask once a day.
Category
Treatment - Drugs
2
Description
Intervention group 2: Eucalyptus plant, nebulizer 2% eucalyptus plant with 5 cc of normal saline for 15 minutes once a day with a special nebulizer mask.
Category
Treatment - Drugs
3
Description
Control group: routine interventions
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Allameh Behlool Gonabadi Hospital
Full name of responsible person
Maryam Moradi
Street address
Allameh Behoul Gonabadi Hospital; Parstar blvd; Saadi street
City
Gonabad
Province
Razavi Khorasan
Postal code
۹۷۸۵۲_۹۶۹۱۷
Phone
+98 51 5723 6832
Email
moradi.mf69@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr. Shahla Khosravan
Street address
Research Center for Social Determinants of Health, Gonabad University of Medical Sciences, Next to the Asian Road
City
Gonabad
Province
Razavi Khorasan
Postal code
۹۶۹۱۷۹۳۷۱۸
Phone
+98 51 5722 9025
Email
moradi.mf69@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice Chancellor for Research and Technology of Gonabad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Maryam Moradi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Vice Chancellor for Research; Gonabad University of Medical Sciences; Next to the Asian Road
City
Gonabad
Province
Razavi Khorasan
Postal code
۹۶۹۱۷۹۳۷۱۸
Phone
+98 51 5722 9025
Email
moradi.mf69@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Maryam Moradi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Research Center for Social Determinants of Health, Gonabad University of Medical Sciences, Next to the Asian Road
City
Gonabad
Province
Razavi Khorasan
Postal code
۹۶۹۱۷۹۳۷۱۸
Phone
+98 51 5722 9025
Email
moradi.mf69@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Maryam Moradi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Khorasan Razavi - Gonabad, Asian Roadside, Vice Chancellor for Research and Technology Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
۹۶۹۱۷۹۳۷۱۸
Phone
+98 51 5722 9025
Email
moradi.mf69@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to the observance of ethics in research, confidentiality of information as well as university rules, raw data files will not be provided to other researchers.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available