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IRCT20200506047323N2 IRCT 2020-05-31 Bandare-abbas University of Medical Sciences Effects of Licorice in treatment of COVID-19 Evaluation of the effects of Licorice on clinical symptoms and laboratory signs in patients with COVID-19: An open-label randomized clinical trial 2020-05-21 anticipated 60 Complete https://irct.ir/trial/47990 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization method and table of random numbers will be used. If selected number is even, the patient is allocated to treatment group, and if it is odd, the patient is allocated to control group. 3 COVID-19 disease. Intervention 1: Intervention group: The standard treatment regimen for COVID-19 based on the Ministry of Health's protocol, including hydroxychloroquine sulfate (Amin Pharmaceutical company, Isfahan) at a dose of 200 mg twice a day, along with a licorice-based herbal medicine (D-REGLIS 380 mg tablets, registration number: 4750956176234914, Irandarouk Pharmaceutical Company) at a dose of 760 mg three times a day for a period of 14 days. Intervention 2: Control group: Standard treatment for COVID-19 based on the Ministry of Health's protocol, including hydroxychloroquine sulfate (Amin Pharmaceutical company, Isfahan) at a dose of 200 mg twice a day for a period of 14 days. Yes - There is a plan to make this available What will be shared: Information regarding the study outcomes will be shared. When: Data will become available after publication of obtained results To whom: Only academic institutions Conditions: The study protocol or proposal should be approved by Ethics committee of institutions. The rights of authors and sponsors should be respected. Where to obtain: M.fathalipour@yahoo.com M.fathalipour@hums.ac.ir How to obtain: این درخواست باید خطاب به معاونت تحقیقات و فناوری دانشگاه علوم پزشکی هرمزگان باشد و با اطلاع مجری طرح انجام می شود. Comments:
public Mohammad Fathalipour
Emam Hossein Blvd
Bandar Abbas Iran (Islamic Republic of) 7919691982 +98 76 3371 0406 m.fathalipour@hums.ac.ir Bandare-abbas University of Medical Sciences scientific Parivash Davoodian
Jomhuri Eslami Blvd
Bandar Abbas Iran (Islamic Republic of) 7919915519 +98 76 3333 3280 parivash.davoodian@hums.ac.ir Bandare-abbas University of Medical Sciences Iran (Islamic Republic of) Age ≥18 years Positive polymerase chain reaction (PCR) test for COVID-19 or/and lung involvement in imaging Primary clinical symptoms Hospitalized Signing informed consent and willingness of study participant to accept randomization to any assigned treatment arm 18 years no limit Both Underlying diseases (heart disease, chronic hypertension, severe renal failure, severe liver failure, and thyroid disorders) Use of warfarin, SSRIs, MAOIs, diuretics, corticosteroids, and antiarrhythmic drugs History of drug allergy Pregnancy and breastfeeding U07.2 COVID-19, virus not identified Treatment - Drugs Treatment - Drugs Intervention group: The standard treatment regimen for COVID-19 based on the Ministry of Health's protocol, including hydroxychloroquine sulfate (Amin Pharmaceutical company, Isfahan) at a dose of 200 mg twice a day, along with a licorice-based herbal medicine (D-REGLIS 380 mg tablets, registration number: 4750956176234914, Irandarouk Pharmaceutical Company) at a dose of 760 mg three times a day for a period of 14 days Control group: Standard treatment for COVID-19 based on the Ministry of Health's protocol, including hydroxychloroquine sulfate (Amin Pharmaceutical company, Isfahan) at a dose of 200 mg twice a day for a period of 14 days. Body temperature. Timepoint: Before intervention and daily during the study. Method of measurement: Thermometer. Respiratory rate. Timepoint: Before intervention and daily during the study. Method of measurement: Respiratory Count. Oxygen saturation. Timepoint: Before intervention and daily during the study. Method of measurement: Pulse oximeter. Lymphocytopenia. Timepoint: Before intervention and days 7 and 14 after the intervention. Method of measurement: Cell count. C-reactive protein. Timepoint: Before intervention and days 7 and 14 after the intervention. Method of measurement: C-RP kit. Incidence of serious adverse events. Timepoint: Before intervention and daily during the study. Method of measurement: Questionnaire. Hormozgan University of Medical Sciences Approved 2017-05-06 Ethics committee of Hormozgan University of Medical Sciences Jomhuri Eslami Blvd Bandar Abbas Hormozgan Iran (Islamic Republic of)