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IRCT20181208041886N2 IRCT 2020-10-29 Exir Danesh Asia Pharmaceutical company Aftogel and COVID-19 PCR test The effect of Aftogel strips on results of nasopharyngeal secretion PCR test in volunteers with positive test for COVID-19 virus 2020-11-21 anticipated 60 Complete https://irct.ir/trial/51774 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. N/A COVID-19. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: the article from this study will be published about the effect of the herbal drug (Aftogel) on the COVID-19 RtPCR test. When: Immediately after article publish. To whom: Every body Conditions: No condition except the conditions of the publisher Where to obtain: the article which will be published How to obtain: the procedure which will be prescribed by the publisher Comments: No comment
public Morteza Pourahmad
Sofeh street
Isfahan Iran (Islamic Republic of) 8189111491 +98 31 3322 0996 mortezapourahmad@yahoo.com Esfahan University of Medical Sciences scientific Dr. Morteza Pourahmad
Sofe Street
Isfahan Iran (Islamic Republic of) 8189111491 +98 31 3322 0996 mortezapourahmad@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Every body with positive COVID-19 Rt PCR Positive regard of the patient for cooperation 18 years no limit Both 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 U07.1COVID U07.1 COVID-19, virus identified•U07.2 COVID-19, virus not identifiedoClinically-epidemiologically diagnosed COVID-19oProbable COVID-19 oSuspected COVID-19 Treatment - Drugs Treatment - Drugs 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. 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. Negative COVID-19 Rt-PCR test after consuming the drug. Timepoint: 5 days. Method of measurement: COVID-19 Rt- PCR test on nasopharyngeal secretions. Exir Danesh Asia Pharmaceutical company Approved 2020-09-21 Ethics committee of Isfahan University of Medical Sciences Sofeh street Isfahan Isfehan Iran (Islamic Republic of)