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IRCT20140312016968N2 IRCT 2020-11-01 Shahid Beheshti University of Medical Sciences Study of the effects of grapefruit extract on COVID-19 Pilot study of the Grapefruit seed extract adjuvant therapy on COVID-19 2020-04-21 anticipated 20 Complete https://irct.ir/trial/47381 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients with inclusion criteria are allocated to a medication or placebo category based on coin chance, Blinding description: Only the principal investigator knows the codes and all of the clinical staff are blinded. Containers containing the medicine/ placebo, their color and viscosity are the same, but their taste is different. N/A COVID-19. Intervention 1: Intervention group: For 7 days, three times a day, each time 10 drops of grapefruit seed extract in addition to routine medication that is Kaltra receive. The medicine should be poured in half a glass of water and consumed. The drug uses the GSE brand made by Nutribiotic Company, which is dissolved in oral glycerin, which has been poured and labeled to be hidden in plastic dropper containers. Intervention 2: Control group: For 7 days, three times a day, each time 10 drops of orange concentrate in addition to routine medication that is Kaltra receive. The medicine should be poured in half a glass of water and consumed. The placebo solution is Sunich orange extract, which is poured into the same plastic dropper containers and labeled the same as the medicine, only the code is different. Yes - There is a plan to make this available What will be shared: Generalities are presented as a printed article. And detailed information is available to the researcher and is provided whenever requested. When: Since the publication of the article To whom: Researchers and regulatory organizations Conditions: To review the results by regulatory agencies and researchers Where to obtain: To the principal investigator and clinical associate How to obtain: By email to the principal investigator aliziai@sbmu.ac.ir Comments:
public Majid Marjani
Darabad, Shahid Bahonar St.
Tehran Iran (Islamic Republic of) 1956944413 +98 21 2610 5050 marjani216@hotmail.com Shahid Beheshti University of Medical Sciences scientific Seyed Ali Ziai
Koodakyar St., daneshjoo Blvd., Velenjak
Tehran Iran (Islamic Republic of) 1985717443 +98 21 2243 9969 saziai@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Ages between 18-60 years Inpatients of the wards Daily Lopinavir / Ritonavir PCR confirmed COVID-19 Without background disease 18 years 60 years Both Age above 60 and below 18 Cardiovascular disease Diabetes Autoimmune disease Renal disease Respiratory distress on admission time Allergy history Consumption of cardiovascular drugs, anti diabetes, anti coagulants, anti HIV, anti cholesterol, immunsuppressive, and cancer chemotherapy agents Reluctance to participate in the study U07.1 COVID-19, virus identified Treatment - Drugs Placebo Intervention group: For 7 days, three times a day, each time 10 drops of grapefruit seed extract in addition to routine medication that is Kaltra receive. The medicine should be poured in half a glass of water and consumed. The drug uses the GSE brand made by Nutribiotic Company, which is dissolved in oral glycerin, which has been poured and labeled to be hidden in plastic dropper containers. Control group: For 7 days, three times a day, each time 10 drops of orange concentrate in addition to routine medication that is Kaltra receive. The medicine should be poured in half a glass of water and consumed. The placebo solution is Sunich orange extract, which is poured into the same plastic dropper containers and labeled the same as the medicine, only the code is different. O2 saturation. Timepoint: Measurement of oxygen saturation every day during the study. Method of measurement: Pulse oximetry device. Adverse drug reaction. Timepoint: Daily recording of possible adverse effects of the extract. Method of measurement: Observational recording. Shahid Beheshti University of Medical Sciences Approved 2020-04-06 Ethics committee of Shahid Beheshti University of Medical Sciences Shahid Beheshti University of Medical Science, Arabi St., Daneshjoo Blvd., Velenjak Tehran Tehran Iran (Islamic Republic of)