Evaluation of slow release mucoadhesive paste of” MUCODENTOL “ in oral vestibule on symptoms of COVID-19 disease in staff of hospitals of LUMS
Design
Clinical trial with intervention-control groups.
A blind, accidental strain, Phase 1 on 1300 patients.
The rand function of the Excel software was used for randomization.
Settings and conduct
In this study, 1,600 working staffs in the ICU and emergency departments and inpatient wards of the dependent Hospital of LUMS will enter the study.
Staffs taking part in the study are asked to apply two drops of the drug three times a day in the area between the upper lip and upper jaw.
Participants/Inclusion and exclusion criteria
Criteria for entering the study:
- Mental and physical ability to use this drug for three weeks
- Lack of sensitivity to drugs and similar drugs
- Staffs working in the ICU / emergency department/wards/etc
- Men and women
- Be able to communicate for a telephone interview
Criteria for leaving the study:
- Lack of cooperation
- Impossibility of a telephone interview
- Do not use the drug regularly
- Drug sensitivity
- Pregnancy and lactation
Intervention groups
1- Dentol group: Mocodentol ointment is given to them and they are asked to use it three times a day before going to bed and apply two drops of ointment in the upper oral vestibule. It does not need to be renewed until the next morning.
2- Control group: They will not take any medicine or pharmaceuticals.
Main outcome variables
Respiratory symptoms --- General
Severe sore throat
Severe dry cough
Severe shortness of breath
Migration intensity
The severity of erythema
Severity of fever
General information
Reason for update
Acronym
COVID-19
IRCT registration information
IRCT registration number:IRCT20090304001739N3
Registration date:2020-09-01, 1399/06/11
Registration timing:registered_while_recruiting
Last update:2020-09-01, 1399/06/11
Update count:0
Registration date
2020-09-01, 1399/06/11
Registrant information
Name
sepideh vahabi
Name of organization / entity
lorestan medical science university
Country
Iran (Islamic Republic of)
Phone
+98 66 1422 8071
Email address
vahabi.s@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-02, 1399/01/14
Expected recruitment end date
2020-09-05, 1399/06/15
Actual recruitment start date
2020-05-09, 1399/02/20
Actual recruitment end date
2020-09-05, 1399/06/15
Trial completion date
2020-09-05, 1399/06/15
Scientific title
Evaluation of slow release mucoadhesive paste of” MUCODENTOL “ in oral vestibule on symptoms of COVID-19 disease in staffs of hospitals of LUMS
Public title
Evaluation of slow release mucoadhesive paste of” MUCODENTOL “ in oral vestibule on symptoms of COVID-19 disease in hospital staff
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
-Mental and physical ability to use this drug for three weeks- Lack of sensitivity to drugs and similar drugs- staffs working in the ICU / Emergency / Hospital wards of the Corona Center for Nomadic Martyrs- Men and women - Be able to communicate for a telephone interview
Exclusion criteria:
-Lack of cooperation- Impossibility of telephone interviews- Do not use the drug regularly- - Drug sensitivity- Pregnancy and lactation
Age
From 18 years old to 60 years old
Gender
Both
Phase
0
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
1600
Actual sample size reached:
1600
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
All data collector didnot know about which groups staffs are in.
Placebo
Not used
Assignment
Parallel
Other design features
as placebo dosent have special smell of carvacrol we have to use metod of "use ot not use " of drug
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Lorestan University of Medical Sciences
Street address
kamalvand-LUMS
City
khoramabad
Province
Lorestan
Postal code
6587349807
Approval date
2020-04-12, 1399/01/24
Ethics committee reference number
IR.LUMS.REC.1399.013
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, PREVENTION
Primary outcomes
1
Description
Detection and severity if covid 19 disease
Timepoint
at the end of the first - second - third week of participation in study
Method of measurement
Examination by a doctor
Secondary outcomes
1
Description
Respiratory-general symptoms
Timepoint
weekly
Method of measurement
Mild - moderate - severe
2
Description
fever
Timepoint
weekly
Method of measurement
Thermometer
Intervention groups
1
Description
Intervention group: Evaluation of the effect of mucodentol continuous adhesive mucus in the mouth on the occurrence of COVID-19 disease symptoms in nurses working at the end of the first - second - third week of drug use
Category
Treatment - Drugs
2
Description
Control group: They will not take any medication or medication.
Category
N/A
3
Description
we didnt find placebo like carvacrol smell
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
dependent hospital of LUMS
Full name of responsible person
Sepideh Vahabi
Street address
Enghelab street, Shohada Ashayer hospital
City
Khorramabad
Province
Lorestan
Postal code
۶۵۷۴۸۳۹۸۲۳
Phone
+98 66 3322 9923
Email
vahabi.s@lums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Ebrahim Fallahi
Street address
Kamalvand Highway - Lorestan University of Medical Sciences
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3330 0661
Email
publicrelation@lums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
KHORRAMAN pharmacy
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Sepideh vahabi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Enghelab Street - Shohada Ashayer Hospital
City
Lorestan
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3342 8071
Email
vahabi.s@lums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Sepideh vahabi
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Enghelab Street - Shohada Ashayer Hospital
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3342 8071
Email
vahabi.s@lums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Sepideh vahabi
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
enghelab Street - Shohada Ashayer Hospital
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3342 8071
Email
vahabi.s@lums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
If published as an article, Relevant sections are published
When the data will become available and for how long
starts after publishing of results
To whom data/document is available
Available to the public when published
Under which criteria data/document could be used
In our study, all findings will be available for public after analysis and publication
From where data/document is obtainable
All findings are listed in the article and do not need to be referenced
What processes are involved for a request to access data/document
All findings are listed in the article and do not need to be referenced