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IRCT20200506047323N1 IRCT 2020-05-23 Bandare-abbas University of Medical Sciences The effects of Ginger in treatment COVID-19 The effects of Ginger on clinical manifestations and paraclinical features of patients with COVID-19: A randomized double-blind placebo-control clinical trial 2020-11-21 anticipated 84 Complete https://irct.ir/trial/48114 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization will be performed (each block consists 6 patients). Allocation sequence and concealment codes will be generated using www.sealedenvelope.com. The closed envelope method will be used to hide the allocation sequence, Blinding description: The medication and placebo will be coded by the project manager. Patients will be randomly allocated within the blocks based on the hidden codes, and study participants, physicians, and nurses who evaluate the outcomes will be blind to the intervention and studied groups. 3 COVID-19 disease. Intervention 1: Intervention group: The standard treatment regimen for COVID-19 along with a Ginger-based herbal medicine (Vomigone 500 mg tablets, registration number: 9406633051781240, Dineh Iran Pharmaceutical Company) at a dose of 1000 mg three times a day for a period of seven days. Intervention 2: Control group: The 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 seven days, along with a Vomigone-liked placebo tablets (Dineh Iran Pharmaceutical Company) at a dose of two tablets three times a day for a period of seven 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: Requests should be addressed to the Technology and Research Vice-chancellery of Hormozgan University of Medical Sciences and the project executor should informed. 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, including chronic hepatitis, cirrhosis, cholestatic liver diseases, cholecystitis, and peptic ulcers Use of anticoagulant drugs like warfarin, and hormonal drugs History of allergy to ginger Pregnancy and breastfeeding U07.2 COVID-19, virus not identified Treatment - Drugs Treatment - Drugs Intervention group: The standard treatment regimen for COVID-19 along with a Ginger-based herbal medicine (Vomigone 500 mg tablets, registration number: 9406633051781240, Dineh Iran Pharmaceutical Company) at a dose of 1000 mg three times a day for a period of seven days Control group: The 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 seven days, along with a Vomigone-liked placebo tablets (Dineh Iran Pharmaceutical Company) at a dose of two tablets three times a day for a period of seven days SARS-CoV-2 clearance. Timepoint: Before intervention and day 7. Method of measurement: PCR test. Fever. Timepoint: Before intervention and daily during the study. Method of measurement: Thermometer. White blood cell count. Timepoint: Before intervention and day 7. Method of measurement: Labratory. Hospital admission. Timepoint: During the intervention. Method of measurement: Questionnaire. Incidence of serious adverse events. Timepoint: Before intervention and daily during the study. Method of measurement: Questionnaire. Hormozgan University of Medical Sciences Approved 2020-05-20 Ethics committee of Hormozgan University of Medical Sciences Jomhuri Eslami Blvd Bandar Abbas Hormozgan Iran (Islamic Republic of)