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IRCT20201111049348N1 IRCT 2021-01-03 Shahid Beheshti University of Medical Sciences The Effect of Licorice Root Extract on the Treatment of Patients with Covid-19 Comparison of the Effect of Alcoholic Extract of Licorice Root and Placebo Capsule on Alpha Tumor Necrosis Factor (TNF-α) Inflammatory Factor Interleukin-6 (IL-6) and Inflammatory Factor 1-Beta (IL-1β) in Patients with Covid-19 2021-01-29 anticipated 120 Complete https://irct.ir/trial/52276 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this research, the law of random allocation has been used. Thus, in the above study, with a sample size of 120 people, 60 balls for the intervention group (consumers of capsules containing licorice extract) with the title A and 60 balls for the control group (users of placebo capsules) with the title B were placed in a lottery container. And then randomly for each patient the balls are taken out of the container without replacement and the sequence created for each patient is recorded, Blinding description: Because the capsule containing licorice extract and the placebo are exactly the same color and size, patients and the research team are unaware of its contents, and only the treating physician knows which patient has taken which capsule. 3 People with COVID 19 whose disease has been confirmed by Real Time PCR. Intervention 1: Consumption of capsules containing licorice extract in the intervention group.Alcoholic extract of licorice root will be purchased from Shirin Daroo Company and will be received in sterile packages. Prior to purchase, the manufacturer will receive a Certificate of Sale and Good Manufacturing Practice. The received sample will be sent to Zarband Pharmaceutical Company before the final order for glycyrrhizin content analysis and microbial test and the result of the analysis will be received. Alcoholic extract of licorice will be obtained from Shirin Daroo company along with COA product analysis sheet.Then, the sample will be sent to Zardband Pharmaceutical Company for confirmation of the mentioned parameters and final approval according to the standards mentioned in international pharmacopoeias. The extract will be added and mixed thoroughly. The powder obtained in the pharmaceutical factory (Osweh, Iran) will be packaged in an orange gelatin capsule (400 mg) and in a brown opaque can. Capsules containing licorice extract will be taken for one month in the amount of one capsule the day after lunch with a glass of water. Intervention 2: Control group: Placebo in capsules with the same color and size as the drug in cans similar to capsules containing licorice. Microcrystalline cellulose composition under the brand name AVICEL (particle diameter: less than 50 micrometers) as a placebo from the pharmaceutical company (Elixir , Iran) will be purchased. Placebo capsules will be taken for one month in the amount of one capsule per day after lunch with a glass of water. No - There is not a plan to make this available Justification or reason for not sharing IPD is Because patient information is private and not available to the public
public Mrs Shokofe Noori
Shahid Beheshti University of Medical Sciences , Koodkiar Street, Student Boulevard, Velenjak
Tehran Iran (Islamic Republic of) 1985717443 +98 21 2387 2570 shnoori85@yahoo.com Shahid Beheshti University of Medical Sciences scientific Mrs Shokofe Noori
Shahid Beheshti University of Medical Sciences , Koodkiar Street, Student Boulevard, Velenjak
Tehran Iran (Islamic Republic of) 1985717443 +98 21 2387 2570 shnoori85@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Includes people with laboratory confirmation of Quid 19 virus regardless of clinical signs and close association Age over 15 years 15 years no limit Both Patient request to leave the study for any reason Request the treating physician to exclude the patient from the study for any reason History of drug allergies History of allergies Patients with immunodeficiency Patients with hypertension Group of patients with underlying disease U07.1 Placebo Placebo Consumption of capsules containing licorice extract in the intervention group.Alcoholic extract of licorice root will be purchased from Shirin Daroo Company and will be received in sterile packages. Prior to purchase, the manufacturer will receive a Certificate of Sale and Good Manufacturing Practice. The received sample will be sent to Zarband Pharmaceutical Company before the final order for glycyrrhizin content analysis and microbial test and the result of the analysis will be received. Alcoholic extract of licorice will be obtained from Shirin Daroo company along with COA product analysis sheet.Then, the sample will be sent to Zardband Pharmaceutical Company for confirmation of the mentioned parameters and final approval according to the standards mentioned in international pharmacopoeias. The extract will be added and mixed thoroughly. The powder obtained in the pharmaceutical factory (Osweh, Iran) will be packaged in an orange gelatin capsule (400 mg) and in a brown opaque can. Capsules containing licorice extract will be taken for one month in the amount of one capsule the day after lunch with a glass of water. Control group: Placebo in capsules with the same color and size as the drug in cans similar to capsules containing licorice. Microcrystalline cellulose composition under the brand name AVICEL (particle diameter: less than 50 micrometers) as a placebo from the pharmaceutical company (Elixir , Iran) will be purchased. Placebo capsules will be taken for one month in the amount of one capsule per day after lunch with a glass of water. Interleukin 6( IL-6). Timepoint: Major measurements of variables are performed on the first day before the intervention and on the 10th day after the intervention. Method of measurement: Using the kit. Interleukin One Beta( IL-1β). Timepoint: Major measurements of variables are performed on the first day before the intervention and on the 10th day after the intervention. Method of measurement: Using the kit. Alpha tumor necrosis factor(TNF-α). Timepoint: Major measurements of variables are performed on the first day before the intervention and on the 10th day after the intervention. Method of measurement: Using the kit. The international normalized ratio (INR). Timepoint: Sampling is done on the first day before the intervention and on the 10th day after the intervention for the main and routine variables of the study. Method of measurement: Through a clinical laboratory. D -Dimmer. Timepoint: Sampling is done on the first day before the intervention and on the 10th day after the intervention for the main and routine variables of the study. Method of measurement: Through a clinical laboratory. Fibrinogen. Timepoint: Sampling is done on the first day before the intervention and on the 10th day after the intervention for the main and routine variables of the study. Method of measurement: Through a clinical laboratory. Ferritin. Timepoint: Sampling is done on the first day before the intervention and on the 10th day after the intervention for the main and routine variables of the study. Method of measurement: Through a clinical laboratory. C Reactive Protein (CRP). Timepoint: Sampling is done on the first day before the intervention and on the 10th day after the intervention for the main and routine variables of the study. Method of measurement: Through a clinical laboratory. Shahid Beheshti University of Medical Sciences Approved 2020-10-11 Shahid Beheshti University of Medical Sciences Velenjak Daneshjo Boulevard Kodakyar Alley Tehran Tehran Iran (Islamic Republic of)