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IRCT20200725048199N1 IRCT 2020-08-11 Dezfoul University of Medical Sciences Evaluation of the effect of Shalomin on the treatment and improvement of symptoms in patients with Covid 19 Investigating the effect of oral and spray shalomine on the treatment and improvement of symptoms in patients with COVID19 2020-08-10 anticipated 146 Complete https://irct.ir/trial/49853 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Initially, random sampling is simple and uses a random number table. Samples are selected over a two-week period. In the next step, using block randomization, patients are divided into two groups of 73 intervention patients (oral shalomin and its respiratory spray) and a 73-member control group (without additional intervention). The basis of block random division is based on a quadruple chain of combinations A (intervention group) and B (control group), Blinding description: In terms of blinding, this study is performed as a double-blind. In the control group, syrups and sprays containing distilled water are used to blind patients. Based on the labeling of the main drug and placebo, the researcher will also be unaware of the use of intervention in groups. Proper blinding is done in two directions (Double Blinding). 3 Coronavirus disease (COVID-19). Intervention 1: The intervention group, in addition to receiving the approved treatment protocol for COVID19, uses Shalomin oral syrup (prepared from shallot extract) 10 cc every 6 hours and Shalomin spray 1 puff every 6 hours in each nostril and 2 puffs in the throat. To prepare the antiviral fraction, which is one of the flavonoids in the active plant ingredients, first aqueous extract is prepared from shallot plant, then column chromatography is used to separate the active ingredient from the extract and the active ingredient is separated and purified. It is then used as a syrup and spray for formulation. The formulation of the drug is a syrup containing 0.1% shalomine and 10% glycerin in double distilled water and a spray containing 0.1% shalomine and 10% ethanol in double distilled water, which will be prepared in Sadra Noor Biotechnology Pharmaceutical Company. (This drug has been patented by Dr. Mansour Amin for the treatment of herpes simplex virus type 1). Intervention 2: Control group: The control group will receive the approved treatment protocol for COVID19 without additional intervention. Yes - There is a plan to make this available What will be shared: After the study, the demographic information and clinical and paraclinical status of patients and the result of their treatment will be provided to researchers in an anonymous and completely confidential manner. When: 6 months after the publication of research results. To whom: Academic researchers and scientific centers Conditions: For therapeutic and research use Where to obtain: The first author or responsible author of the research article mahnaz.nosratabadi@gmail.com How to obtain: After communicating via email with the author or the first person of the published article, the accuracy and scientific status of the applicant will be checked and identified, and after confirmation, the information will be provided to the applicants as soon as possible. Comments: Any contribution to the dissemination of science in the field of current research can be provided, we are ready to cooperate.
public mahnaz nosratabadi
Azadegan Boulevard
Dezful Iran (Islamic Republic of) 6461665145 +98 61 4242 3308 nosratabadi.m@Dums.ac.ir Dezfoul University of Medical Sciences scientific mahnaz nosratabadi
Azadegan Boulevard
Dezful Iran (Islamic Republic of) 6461665145 +98 61 4242 3308 nosratabadi.m@Dums.ac.ir Dezfoul University of Medical Sciences Iran (Islamic Republic of) Positive coronavirus test willingness to participate in the study not receiving any medication other than the common COVID19 treatment protocol people who need to be hospitalized based on blood oxygen saturation and respiratory status. no limit no limit Both Infection with other microbial or viral infections severe form of COVID19 disease inability to use syrup and respiratory spray Shalomin U07.1 COVID-19, virus identified Treatment - Drugs Treatment - Drugs The intervention group, in addition to receiving the approved treatment protocol for COVID19, uses Shalomin oral syrup (prepared from shallot extract) 10 cc every 6 hours and Shalomin spray 1 puff every 6 hours in each nostril and 2 puffs in the throat. To prepare the antiviral fraction, which is one of the flavonoids in the active plant ingredients, first aqueous extract is prepared from shallot plant, then column chromatography is used to separate the active ingredient from the extract and the active ingredient is separated and purified. It is then used as a syrup and spray for formulation. The formulation of the drug is a syrup containing 0.1% shalomine and 10% glycerin in double distilled water and a spray containing 0.1% shalomine and 10% ethanol in double distilled water, which will be prepared in Sadra Noor Biotechnology Pharmaceutical Company. (This drug has been patented by Dr. Mansour Amin for the treatment of herpes simplex virus type 1). Control group: The control group will receive the approved treatment protocol for COVID19 without additional intervention. Alteration of clinical and paraclinical symptoms of Covid 19 in patients. Timepoint: Once every three days after starting treatment until finally one month after starting treatment. Method of measurement: Based on vital signs and paraclinical information. Corona virus test result. Timepoint: Two weeks after starting treatment. Method of measurement: Based on the results of corona virus polymerase chain reaction test. Dezfoul University of Medical Sciences Approved 2020-07-07 Ethics committee ofِ Dezful University of Medical Sciences No. 162, Ghoncheh St., Rusta Blvd. Dezful Khouzestan Iran (Islamic Republic of)