Investigating the effect of slow release mucosal drug in mouth " MUCODENTOL" on disease Symptoms in COVID-19 patients.
Design
A randomized clinical trial with intervention / control and placebo groups on 200 patients. Excel software rand function was used for randomization. This study is not blind.
Settings and conduct
The study population consists of all infected patients with COVID-19 that hospitalized or referred to Shahid Beheshti Hospital in Qom in 1399. An infected person with Covid-19 should be diagnosed with clinical and radiographic symptoms or a positive CT scan that confirmed by two radiologists.
Sampling method: Convenience sampling from qualified people who are hospitalized in Shahid Beheshti Hospital in Qom and using the method of stratified random blocks (class in order to match the groups in terms of patient severity to COVID-19) for assigning patients to the study groups.
Participants/Inclusion and exclusion criteria
-Inclusion criteria
1- Age over 18 years
2- Mental and physical ability to use this drug for three weeks
3- No history of previous allergy to drugs and similar drugs
4- Definitive diagnosis of COVID-19
5 - People are aware of time, place and person and are intellectually and mentally in a normal state.
6- Be able to communicate verbally in the interview by phone or in person
7- The patient should not be hospitalized in the intensive care unit.
- exclusion criteria
1- Impossibility of a telephone interview
2- Pregnancy and lactation
3- Allergy to drugs
Intervention groups
Dentol group: mucodentol paste (carvacrol 3%) produced in Khorraman Pharmaceutical Company has been recommended to use it three times a day as well as before going to the bed and put the paste between the upper lip and gums. It does not need to be renewed until the next morning. Control group 2: They will not take any medicine or placebo.
Main outcome variables
COVID-19 symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130428013151N2
Registration date:2020-10-28, 1399/08/07
Registration timing:retrospective
Last update:2020-10-28, 1399/08/07
Update count:0
Registration date
2020-10-28, 1399/08/07
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 1322 4918
Email address
farzan.b@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-25, 1399/02/06
Expected recruitment end date
2020-05-26, 1399/03/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of slow release mucosal drug in mouth " MUCODENTOL" on disease Symptoms in COVID-19 patients.
Public title
Evaluation of the effect of mucodentol on people with coronavirus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years old
Mental and physical ability to use this drug for three weeks
Lack of sensitivity to drugs and similar drugs
People are aware of time, place
person, are mentally and emotionally normal
be able to communicate verbally for telephone interviews
Infected to covid-19
Exclusion criteria:
Lack of cooperation
Do not use the drug regularly
Having corona and need to be hospitalized
Drug sensitivity
Pregnancy and lactation
Age
From 18 years old to 60 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
The quadruple block method is used to assign patients to two groups A (intervention) and group B (control). To do this, first write a list of blocks and assign numbers to them. (AABB (1) - ABAB (2) - ABBA (3) - BBAA (4) - BABA (5) - BAAB (6) Then use the random number table to randomly select numbers between 1 and 6 and finally the assignment list The treatment will be based on a sequence of letters A and B. Excel software rand function was used for randomization.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Lorestan University of Medical Sciences
Street address
Kamalvand Highway - Lorestan University of Medical Sciences
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Approval date
2020-05-06, 1399/02/17
Ethics committee reference number
IR.LUMS.REC.1399.046
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
The symptoms caused by the Covid-19
Timepoint
Three times a day before bed
Method of measurement
In case of home quarantine, since it is advisable for personal protection, people should not leave the house. At the end of the first week, Second and third week, the desired symptoms will be asked and recorded as a telephone interview. In case of hospitalization, patients will be interviewed and examined.
Secondary outcomes
1
Description
fever
Timepoint
daily
Method of measurement
Thermometer
2
Description
Respiratory-general symptoms
Timepoint
daily
Method of measurement
yes/no
Intervention groups
1
Description
Dental Intervention Group: mucoadhesive slow-release paste mucodentol (carvacrol 3%) produced in Khorraman Pharmaceutical Company located in Khorramabad has been recommended to use it three times a day as well as before going to the bed by participants and put the paste between the upper lip and gums.
Category
Treatment - Drugs
2
Description
Control group: will not take any medicine or placebo.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital-Qom
Full name of responsible person
Behrooz Farzan
Street address
Qom Province, Qom, Beheshti Blvd, Iran
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3612 2000
Email
tsabokbar@muq.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
University of Medical Sciences, Shahid Anoushirvan Rezaei Square,Moallem St,Khorramabad,Lorestan,Iran
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?
Yes
Title of funding source
Khoram-Abad 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
Khoram-Abad University of Medical Sciences
Full name of responsible person
Behrooz Farzan
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Bimarestan street, Shohada Ashayer hospital
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
0098 66 33300661
Email
farzan.b@lums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Behrooz Farzan
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Bimarestan street, Shohada Ashayer hospital
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3330 0661
Email
publicrelation@lums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Behrooz Farzan
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Bimarestan street, Shohada Ashayer hospital
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3330 0661
Email
publicrelation@lums.ac.ir
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