The effect of Aftogel strips on nasopharyngeal secretion PCR test in volunteers with positive test for COVID-19 virus
Design
This study is a double blind clinical trial which has two intervention and control groups which will be followed parallel. For randomization the patients will be located in quadruplet blocks in which 2 patients will receive the placebo and 2 patients will receive the tentative drug. After the study the codes of the drug will be opened and the results will be evaluated.
Settings and conduct
This study will be conducted in outpatient clinic. and the patients which are in stage 0 or 1 of the disease will be enrolled in the study. After selection on inclusion and exclusion criteria the patients will be located in one of the intervention and control group and the drugs which nominated by a code will be gave to the patients and after 5 days the COVID-19 RtPCR will be done on the patients. At the end the codes of the drug will be opened and the results of the tests will be evaluated.
Participants/Inclusion and exclusion criteria
Every patient with positive COVID-19 PCR and positive regard for our study will be accepted for study and if the patient who has one of the below condition will not be accepted for study: age below 18 years, on compliance for use our drug, old age, mental disturbance, user of other chemical and/or any traditional drug, the patients with underlying diseases such as hypertention, user of oral antiseptic solutions and the users of antiviral drugs.
Intervention groups
Strip of the drug (Aftogel) and placebo will give the patients and request them to consume the drugs 4 times a day. they should retain the drug in their mouth till to wash by their saliva and consume. Five days later the COVID-19 PCR test will be repeat on their nasopharyngeal secretions.
Main outcome variables
Positive or negative COVID-19 RtPCR test after consuming the drug.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181208041886N2
Registration date:2020-10-29, 1399/08/08
Registration timing:prospective
Last update:2020-10-29, 1399/08/08
Update count:0
Registration date
2020-10-29, 1399/08/08
Registrant information
Name
Morteza Pourahmad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3322 0197
Email address
mortezapourahmad@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Aftogel strips on results of nasopharyngeal secretion PCR test in volunteers with positive test for COVID-19 virus
Public title
Aftogel and COVID-19 PCR test
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Every body with positive COVID-19 Rt PCR
Positive regard of the patient for cooperation
Exclusion criteria:
age< 18 years old
No compliance for drug consumption
Very old age patients and the patients with mental disturbance which can not cooperate.
the patients who use other chemical and/or traditional drugs
the patients with underlying diseases such as Hypertention
the patients who use antiseptic oral solutions
the patients who use antiviral drugs
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
the selected patients on inclusion and exclusion criteria in out patient clinic they will be located in nominated quadruplet blocks and in every block they will be located in placebo or intervention groups and will be received their own drugs.
Blinding (investigator's opinion)
Double blinded
Blinding description
For blinding the study; the palcebo and tentative drug will be used in same form and same boxes with different codes. the physician and the patient both , will not be informed about the drugs and only the pharmacist will be informed about the nature of the drugs. At the end of study the codes will be opened and the results will be evaluated.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Negative COVID-19 Rt-PCR test after consuming the drug
Timepoint
5 days
Method of measurement
COVID-19 Rt- PCR test on nasopharyngeal secretions
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: the patients with positive COVID-19 Rt PCR test will be selected and on random manner they will be treated with tentative drug (Aftogel strip) . This drug is made by Exir Danesh Asia pharmaceutical company and contain the extract of black licorice. Black licorice contain 7% glycyrrhizin which has known antiviral effects. This drug is made in form of strip. In every time of use the patient will use 2 strip of this drug and will keep it in mouth for about 30 minutes till it resolves completely by saliva and be swallowed. The patient should repeat this using four times a day and for five days. The patients will be instructed about the method of use by physician.
Category
Treatment - Drugs
2
Description
Control group:the patients with positive COVID-19 Rt PCR test will be selected and on random manner they will be treated with placebo drug (as strip) . This drug is made by Exir Danesh Asia pharmaceutical company and will be in the same form as Aftogel strip (which will be used in intervention group) and will not contain the extract of black licorice. In every time of use the patient will use 2 strip of this drug and will keep it in mouth for about 30 minutes till it resolves completely by saliva and be swallowed. The patient should repeat this using four times a day and for five days. The patients will be instructed about the method of use by physician.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amin out patient clinic in Isfahan
Full name of responsible person
Dr. Morteza Pourahmad
Street address
Sofeh street
City
Isfahan
Province
Isfehan
Postal code
8189111491
Phone
+98 31 3322 0996
Email
mortezapourahmad@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Exir Danesh Asia Pharmaceutical company
Full name of responsible person
Dr. Mohsen Saniei
Street address
Hakim Nezami street
City
Isfahan
Province
Isfehan
Postal code
8175978467
Phone
+98 31 3624 1167
Email
admin@exirpd.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Exir Danesh Asia Pharmaceutical company
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Morteza Pourahmad
Position
professor of infectious diseases
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Sofeh street
City
Isfahan
Province
Isfehan
Postal code
8189111491
Phone
+98 31 3322 0996
Email
mortezapourahmad@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Morteza Pourahmad
Position
Professor of infectious diseases
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Sofe Street
City
Isfahan
Province
Isfehan
Postal code
8189111491
Phone
+98 31 3322 0996
Email
mortezapourahmad@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Morteza Pourahmad
Position
Professor of Infectious diseases
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Sofe street
City
Isfahan
Province
Isfehan
Postal code
8189111491
Phone
+98 31 3322 0996
Email
mortezapourahmad@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
the article from this study will be published about the effect of the herbal drug (Aftogel) on the COVID-19 RtPCR test.
When the data will become available and for how long
Immediately after article publish.
To whom data/document is available
Every body
Under which criteria data/document could be used
No condition except the conditions of the publisher
From where data/document is obtainable
the article which will be published
What processes are involved for a request to access data/document
the procedure which will be prescribed by the publisher