The aim of this study is to compare the effect of the bromhexine hydrochloride solution for inhalation and placebo on the improvement of respiratory condition in patients with COVID-19 by focusing on the severity of the cough.
Design
A double-blinded randomized, placebo-controlled clinical trial with parallel groups, on 78 patients. Blocks of 4 will used for randomization
Settings and conduct
The study is carried out in Semnan Kowsar Hospital and in an interventional approach. The patients are assigned into two groups, intervention group will receive the bromhexine hydrochloride solution for inhalation, 8 mg, three times a day for 7 days via a nebulizer mask and the control group receives placebo (normal saline in the same volume as inhaled bromhexine) in the same way and time pattern.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Positive result for PCR and Age more than 18 years
Exclusion criteria: Oxygen saturation level of lower than 90% and hypotension
Intervention groups
The way to get the medicine to the test group is that 8mg of Girambromhexine inhaled through a nebulizer mask every 8 hours for one week in Kausar Semnan hospital and 8mg of normal saline inhaled every 8 hours for 7 days to the control group.
Main outcome variables
Comparison of the respiratory function of patients based on cough severity, arterial blood oxygen saturation and carbon dioxide level as indicators of respiratory function.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230514058188N1
Registration date:2023-06-13, 1402/03/23
Registration timing:registered_while_recruiting
Last update:2023-06-13, 1402/03/23
Update count:0
Registration date
2023-06-13, 1402/03/23
Registrant information
Name
Sima gharibshah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3343 4253
Email address
simagharibshah@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-10, 1402/03/20
Expected recruitment end date
2023-10-11, 1402/07/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of inhaled bromhexine on clinical and laboratory symptoms and COVID-19
Public title
The effect of inhaled bromhexine on clinical symptoms and recovery of COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with COVID-19 confirmed by PCR
Patients with respiratory symptoms including caugh and dyspnea
Exclusion criteria:
Need to mechanical ventilation
Pregnancy or lactating
Peptic ulcer
Age
From 18 years old to 90 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
78
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, a block randomization method will be used. In the study, the allocation of samples is based on a random sequence provided by a statistical expert using statistical software. The block size will be 6. Meanwhile, the tool which is used for generating random-sequence blocks is a web-based software available at https://kitset.ir/numbers/random.
Blinding (investigator's opinion)
Double blinded
Blinding description
The blinding of the study is such that the outcome assessor and biostatistician do not know the content of the intervention. For administration, the drug will be given to the clinical care provider for administration by mentioning the administration method. The outcome assessor records the outcome based on the patient's identity number according to the randomization table, and the data collected based on the number and mention of the first and second intervention is provided to the biostatistician for analysis.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
kosar hospital , Amin Street , Golestan Town , Semnan
City
Semnan
Province
Semnan
Postal code
3519899951
Approval date
2023-05-01, 1402/02/11
Ethics committee reference number
IR.SEMUMS.REC.1402.015
Health conditions studied
1
Description of health condition studied
Dyspnea
ICD-10 code
R06
ICD-10 code description
Abnormalities of breathing
Primary outcomes
1
Description
Cough Severity
Timepoint
Before intervention and daily up to 7 day after intervention
Method of measurement
Visual Analogue Score
Secondary outcomes
1
Description
Arterial blood O2 saturation
Timepoint
Before intervention and daily up to 7 days after intervention
Method of measurement
Atrial blood gas measurment
2
Description
Arterial blood carbon dioxide level
Timepoint
Before intervention and daily up to 7 days after intervention
Method of measurement
Atrial blood gas measurment
Intervention groups
1
Description
Intervention group: Patients will receive bromhexine hydrochloride solution for inhalation (Mucolin ampoule 4 mg/2 ml, manufactured by Daru Pharmaceutical Company, Iran) 8 mg every 8 hours via a nebulizer mask for 7 days.
Category
Treatment - Drugs
2
Description
Control group: The patients will receive placebo (normal saline in a volume equal to inhaled bromhexine) every 8 hours through a nebulizer mask for 7 days.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar hospital
Full name of responsible person
Sima Gharibshah
Street address
Amin Street , Golestan Town
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3142 2120
Email
Simagharibshah@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Majid Mirmohammadkhani
Street address
Central Office of Semnan University of Medical Sciences, Basidj Blvd.
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
rds@semums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Mohammad Memarian
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Kowsar hospital, Amin Street , Golestan Town
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3142 2120
Email
draria2014@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohammad Foroozeshfard
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Kowsar hospital, Amin Street , Golestan Town
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3142 2230
Email
mff45@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Sima Gharibshah
Position
Researcher
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Amin Street , Golestan Town
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3142 2120
Email
Simagharibshah@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data will be presented anonymously.
When the data will become available and for how long
From the March of 2024
To whom data/document is available
All researchers and workers in the medical sciences
Under which criteria data/document could be used
The condition of using the data is that if it is used in scientific research, the name of the researchers of this project should be included.
From where data/document is obtainable
If needed, can be available by contacting the person responsible for general inquiries, Dr. Mohammad Memarian via email: draria2014@gmail.com.
What processes are involved for a request to access data/document
First, with one of the mentioned methods, he informs the researcher what information he needs; Then, if possible, the information will be sent to them one week later.