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IRCT20200516047462N1 IRCT 2020-05-17 Kashan University of Medical Sciences Intervention The effect of methanolic extract of hyoscyamus niger containing steroidal glycosides with propolis in patients with acute respiratory infection (infection or suspected covid-19): A clinical trials 2020-05-06 anticipated 50 Complete https://irct.ir/trial/48141 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: After acceptance and registration, these samples are entered in study by physician and nurse of clinic and also project manager based on the entry and exit criteria. The samples are divided into two groups by method of terminated block randomization with blocks 4 and 6. Prescriptive drugs (intervention and placebo) are determined based on this method with a special number to them. Physician and patient are not aware of intervention type and the patient's assignment to each treatment will be assign randomly, Blinding description: Physician and patient are unaware of drug or placebo receiving and there are codes that were registered on syrup and only the epidemiologist informs as a plan executor. N/A covid 19. Intervention 1: Intervention group: Products containing 10 mg of methanolic extract plus 450 mg of propolis will be prescribed three times a day for each patient. This amount of active ingredients is dissolved in 30cc of simple BP syrup. This 30 cc is ordered in 10cc (one tablespoon) every 8. The time will be prescribed. The formulated syrup will be given to the patients in the amount of 60 cc required by the above-mentioned order for 2 days and the patients will go to the clinic every two days after receiving the medicine again, the questionnaire and clinical symptoms will be referred to the clinic. In addition, suspected patients with covid 19 will be delivered to patients after the approval of an infectious disease specialist and, if the patient agrees, and will receive a signature and fingerprint in the syrup consent form. Prescribing syrup and examining the patient's symptoms are 6 days. Intervention 2: Control group: Simple BP syrup (without therapeutic products) will be prescribed every 10 hours with a 10cc (one tablespoon) recipe. Two days later, the drug will be returned to the clinic, a questionnaire and clinical signs will be sent to the clinic. In addition, suspected patients with covid 19 will be delivered to patients after the approval of an infectious disease specialist and, if the patient agrees, and will receive a signature and fingerprint in the syrup consent form. Prescribing syrup and examining the patient's symptoms are 6 days. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Due to the completion of the second drug research
public Morteza Kosari
No. 16, Hakim Alley. , Montazeri St. , Badrod Town
Isfahan Iran (Islamic Republic of) 8766113894 +98 31 5434 6622 kosarimorteza12@gmail.com Kashan University of Medical Sciences scientific Morteza Kosari
No. 16, Hakim Alley., Montazeri St. , Badrod Town
Badrod Iran (Islamic Republic of) 8766113894 +98 31 5434 6622 kosarimorteza12@gmail.com Kashan University of Medical Sciences Iran (Islamic Republic of) The patient must have a voluntary consent to participate in operation; The patient's clinical symptoms such as: dry cough, shortness of breath, fever, shortness of breath, fatigue, etc. in suspected or associated with COVID-19 is evaluated after treatment and these symptoms are compared with placebo group. no limit no limit Both Heart patients, mental patients and pregnant women U07.1 Covid-19 Treatment - Drugs Placebo Intervention group: Products containing 10 mg of methanolic extract plus 450 mg of propolis will be prescribed three times a day for each patient. This amount of active ingredients is dissolved in 30cc of simple BP syrup. This 30 cc is ordered in 10cc (one tablespoon) every 8. The time will be prescribed. The formulated syrup will be given to the patients in the amount of 60 cc required by the above-mentioned order for 2 days and the patients will go to the clinic every two days after receiving the medicine again, the questionnaire and clinical symptoms will be referred to the clinic. In addition, suspected patients with covid 19 will be delivered to patients after the approval of an infectious disease specialist and, if the patient agrees, and will receive a signature and fingerprint in the syrup consent form. Prescribing syrup and examining the patient's symptoms are 6 days. Control group: Simple BP syrup (without therapeutic products) will be prescribed every 10 hours with a 10cc (one tablespoon) recipe. Two days later, the drug will be returned to the clinic, a questionnaire and clinical signs will be sent to the clinic. In addition, suspected patients with covid 19 will be delivered to patients after the approval of an infectious disease specialist and, if the patient agrees, and will receive a signature and fingerprint in the syrup consent form. Prescribing syrup and examining the patient's symptoms are 6 days. Shortness of breath, medicine, dry cough, chills and etc. Timepoint: May and June. Method of measurement: Quantitative and qualitative. Kashan University of Medical Sciences Approved 2020-05-06 Ethics committee of Kashan University of Medical Sciences Ghotb Ravandi Blvd Kashan Isfehan Iran (Islamic Republic of)