Evaluation of slow release mucoadhesive paste of” Mucodentol “ on symptoms of COVID-19 disease in non infected family members of infected patients by COVID-19
Evaluation of slow release mucoadhesive paste of” Mucodentol “ on symptoms of COVID-19 disease in non infected family members of infected patients by COVID-19
Design
Clinical trial with intervention-control and placebo groups. A blind, accidental strain, Phase 1 on 600 patients. The rand function of the Excel software was used for randomization.
Settings and conduct
In this study, a double-blind clinical trial is performed on the covid-19 patient's companions. 600 family members of coronary patients who have been diagnosed with the disease and have been referred or hospitalized in Qom will be included in the study. These patient companions, both men and women over the age of 18, with any level of education and marital status, will enter the plan if they agree.
Participants/Inclusion and exclusion criteria
Study entry criteria:
1- Age over 18 years
2- Mental and physical ability to use this drug for three weeks
3- The presence of a person with COVID-19 in the family
4- To be able to communicate verbally for a telephone interview
Exclusion criteria:
1-Covid-19 infection
2- Drug sensitivity
3- Underlying diseases: Cardiovascular diseases, Diabetes, Immune system deficiency
4- Pregnancy or 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- Plasbo group: Plasbo ointment is given to them and they are asked to use the ointment in the above order and to apply two drops of the ointment in the upper oral vestibule. 3- 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
IRCT registration information
IRCT registration number:IRCT20200711048076N1
Registration date:2020-09-05, 1399/06/15
Registration timing:retrospective
Last update:2020-09-05, 1399/06/15
Update count:0
Registration date
2020-09-05, 1399/06/15
Registrant information
Name
Sahar Behzad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 0061
Email address
s.behzad@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of slow release mucoadhesive paste of” Mucodentol “ on symptoms of COVID-19 disease in non infected family members of infected patients by COVID-19
Public title
The effect of mucodentol on covid-19 symptoms
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years.
Mental and physical ability to use this drug for three weeks.
Lack of sensitivity to similar drugs.
Existence of a person with COVID -19 in the family.
People are aware of time, place and person, are in a natural state mentally and mentally, Be able to communicate verbally for a telephone interview.
Exclusion criteria:
Covid-19 infection
Drug sensitivity
Underlying diseases: Cardiovascular diseases, Diabetes, Immune system deficiency,...
Pregnancy or lactation
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
600
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized block design (4 blocks) is planned as: group A (intervention) and group B (control). At first, the list of blocks is prepared and numbers are assigned.
AABB(1)- ABAB(2)- ABBA(3)- BBAA(4)- BABA(5)- BAAB(6)
Then numbers between 1 to 6 will be selected by using random number table and finally, assigned list is based on A and B
sequence.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
School of Pharmacy, Shahid Beheshti University of Medical Sciences, ValieAsr-Hashemi Rafsanjani Junction
City
Tehran
Province
Tehran
Postal code
1991953381
Approval date
2020-04-06, 1399/01/18
Ethics committee reference number
IR.SBMU.RETECH.REC.1399.042
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Severity of dry coughs
Timepoint
At the end of the first - second and third week of medication use
Method of measurement
Phone call, Self-declaration and fill the related questionnaire
2
Description
Severity of a sore throat
Timepoint
At the end of the first - second and third week of medication use
Method of measurement
Phone call, Self-declaration and fill the related questionnaire
3
Description
Severity of a shortness of breath
Timepoint
At the end of the first - second and third week of medication use
Method of measurement
Phone call, Self-declaration and fill the related questionnaire
4
Description
severity of a myalgia
Timepoint
At the end of the first - second and third week of medication use
Method of measurement
Phone call, Self-declaration and fill the related questionnaire
5
Description
Severity of arthralgia
Timepoint
At the end of the first - second and third week of medication use
Method of measurement
Phone call, Self-declaration and fill the related questionnaire
6
Description
Severity of fever
Timepoint
At the end of the first - second and third week of medication use
Method of measurement
Phone call, Self-declaration and fill the related questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: All the non-infected family members who live with an infected COVID-19. Every one will receive 3 mucodentol 3% (Khorraman co) tubes for 3 weeks . They will take it on oral upper vestibule BD (ones before sleeping). There is no need to retake it.
Category
Treatment - Drugs
2
Description
Control group: They do not receive Mucodentol but receive all the general advises and self-protection protocols by Iranian ministry of health and medical education for prevention of COVID-19 infection
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Qom Hospitals
Full name of responsible person
Nina Farzan
Street address
Qom, Bazaar Junction, at the beginning of 19th Dey Street (Bajak 1), Kamkar Hospital - Arabnia
City
Qom
Province
Ghoum
Postal code
1991953381
Phone
+98 25 3771 3511
Email
dr.ninafarzan@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sahar Behzad
Street address
School of Pharmacy, Shahid Beheshti University of Medical Sciences, Valieasr-Hashemi Rafsanjani Junction
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 8820 0061
Email
s.behzad@sbmu.ac.ir
Web page address
https://sbmu.ac.ir
Grant name
----------
Grant code / Reference number
------
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Behruz Farzan
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Khoram-Abad University of Medical Sciences,Shahid Anushirvan Rezaie Square, Moallem Street
City
Khoram-Abad
Province
Lorestan
Postal code
6813833946
Phone
0098 6633300661-5
Email
B_farzan41@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Behruz Farzan
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Khoram-Abad University of Medical Sciences,Shahid Anushirvan Rezaie Square, Moallem Street
City
Khoram-Abad
Province
Lorestan
Postal code
6813833946
Phone
0098 6633300661-5
Email
B_farzan41@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sahar Behzad
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmacognosy
Street address
School of Pharmacy, Shahid Beheshti University of Medical Sciences, ValieAsr-Hashemi Rafsanjani Junction
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 8820 0061
Email
s.behzad@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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