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IRCT20200610047722N1 IRCT 2020-07-07 Hossein Nik Tale ٍEffect of Allicin derivatives capsule in treatment of patients with new Coronavirus Comparing the efficacy of Allicin derivatives capsule and Placebo as an adjuvant for patients with COVID-19: A double-blind randomized placebo controlled clinical trial 2020-06-21 anticipated 25 Complete https://irct.ir/trial/48869 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: No, Randomization description: Random allocation to study groups including intervention and placebo will be done using online randomization website (randomization.com). This website will allocate the patients (100) into both medication and placebo groups with the same sample size. The numbers will be produced in a row (between 1-100) for both medication and placebo groups, Blinding description: Medication and placebo will be coded by the researcher. Allicin derivatives capsules and Placebo have the same color, shape and size; so participants, physicians and nurses who evaluate the results are blinded to the intervention and groups allocation. 0 (exploratory trials) Condition 1: COVID-19. Condition 2: COVID-19. Intervention 1: Intervention group: Standard treatment for COVID-19 plus Allicin derivatives capsule (90 mg) twice per day for 14 days. Intervention 2: Control group: Standard treatment for COVID-19 plus Placebo twice per day for 14 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 There is no more information.
public Amir Masoud Hashemian
Emam Reza hospital, Ebn Sina street
Mashhad Iran (Islamic Republic of) ٩١٣٧٩١٣٣١۶ +98 51 3854 3031 hashemianam@mums.ac.ir Mashhad University of Medical Sciences scientific Amir Masoud Hashemian
Ebn Sina street
Mashhad Iran (Islamic Republic of) ٩١٣٧٩١٣٣١۶ +98 51 3854 3031 HashemianAM@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients with RT-PCR positive for SARS-CoV-2 , clinical sign and symptoms (fever, cough and myalgia) and CT scan indicate COVID-19 positive. Age 18-70 Sign consent form 18 years 70 years Both History of allergic reaction to Allicin History of allergic reaction to Garlic or Onion History of low blood pressure or gastrointestinal tract bleeding Low blood pressure and the beginning of study (lower that 120/80 mmHg) Patients with immune deficiency disorders (patients undergo chemotherapy, organ or bone marrow transplants and patients with autoimmune disease) No need to use ventilator during the study Unable to swallow the oral medication Pregnancy Breastfeeding U07.2 U07.1 COVID-19, virus not identified COVID-19, virus identified Treatment - Drugs Placebo Intervention group: Standard treatment for COVID-19 plus Allicin derivatives capsule (90 mg) twice per day for 14 days Control group: Standard treatment for COVID-19 plus Placebo twice per day for 14 days Body temperature. Timepoint: Before starting the study and every day during the study. Method of measurement: Thermometer. O2 saturation. Timepoint: Before starting the study and every day during the study. Method of measurement: pulse oximeter. Time to recovery. Timepoint: Everyday until the full recovery. Method of measurement: WHO criteria for COVID-19. Lymphocytopenia. Timepoint: Before starting the study, one week and two week later. Method of measurement: Cell Counter (CBC). C-reactive protein. Timepoint: Before starting the study, one week and two week later. Method of measurement: C-RP kit. Serious side effects. Timepoint: Before starting the study and everyday during the study. Method of measurement: questionnaire. Hossein Nik Tale Approved 2020-06-06 Ethics committee of Mashhad University of Medical Sciences Daneshgah St, Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)