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IRCT20201128049520N1 IRCT 2021-02-22 Khoram-Abad University of Medical Sciences effect of olive leaf extract on Covid-19 patients The effect of alcoholic extract of the olive leaf on clinical and Laboratory outcomes of patients with Covid-19 2021-03-05 anticipated 129 Complete https://irct.ir/trial/52677 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Allocation of samples in study groups by random blocking method, Blinding description: Capsules containing olive leaf extract in two doses of 250 and 500 mg and placebo are exactly the same in terms of color, shape and size and are coded and packaged by another person without the knowledge of the researcher, analyst and participant The contents of the capsule will be placed in the participants' medicine boxes. Before the start of the study and when informed consent is obtained from the participant, they are informed that they are randomly placed in one of the intervention or control groups. Before the start of the study and when informed consent is obtained from the participant, they are informed that they are randomly placed in one of the intervention or control groups. 2-3 COVID - 19. Intervention 1: Intervention group: Patients who at the same time with standard treatments, capsules containing olive leaf extract (capsules with a dose of 250 mg twice a day for five days) olive leaf extract by Rose Daru Pharmaceutical Company in drug capsules of the same shape and size as other groups The intervention will be prepared and stored in conditions away from light and moisture. Intervention 2: Intervention group: Patients who at the same time with standard treatments, capsules containing olive leaf extract (capsules with a dose of 500 mg twice a day for five days) olive leaf extract by Rose Daru Pharmaceutical Company in drug capsules of the same shape and size as other groups The intervention will be prepared and stored in conditions away from light and moisture. Intervention 3: Control group: Patients who receive placebo at the same time as standard treatments in the form of capsules containing wheat flour twice a day for five days. The placebo will be stored by Rose Drug Pharmaceutical Company in drug capsules of the same shape and size as the other intervention groups prepared away from light and moisture. 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 Elham Ahmadpour
University of Medical Sciences, Shahid Anoushirvan Rezaei Square, Moallem St, Khorramabad
Khorramabad Iran (Islamic Republic of) 381251698 +98 66 3341 3823 elhamahmadpour10@gmail.com Khoram-Abad University of Medical Sciences scientific Elham Ahmadpour
University of Medical Sciences, Shahid Anoushirvan Rezaei Square, Moallem St, Khorramabad
Khorramabad Iran (Islamic Republic of) 381251698 +98 66 3341 3823 elhamahmadpour10@gmail.com Khoram-Abad University of Medical Sciences Iran (Islamic Republic of) All patients with Quid-19 based on standard diagnostic test (positive PCR test, CT scan of lung) approved by infectious disease specialist Age range is 18 to 70 years Have a level of consciousness of 15 according to the Glasgow standard 18 years 70 years Both Take oleopurine supplements 3 months before the study Use of mechanical ventilation equipment Existence of underlying respiratory diseases such as COPD, asthma Taking anti-hypertensive, anti-platelet and anti-diabetic drugs Pregnancy and lactation Immune system deficiency or the use of immunosuppressive drugs Malignancies Presence of heart, kidney, liver, blood pressure, diabetes and corticosteroid disorders Reluctance to continue cooperation The patient is discharged earlier than the completion of the treatment period Hypotension (mean arterial pressure less than 70 mm Hg) Hypoglycemia (blood sugar less than 75 mg / dL) Existence of allergies to drugs before and during the study Lack of proper use of drugs The need for therapeutic interventions other than the usual therapeutic interventions during research such as the need for dialysis, angioplasty and ... Participate in other research that in any way affects the results of the research B34.2 Coronavirus infection, unspecified Treatment - Drugs Treatment - Drugs Placebo Intervention group: Patients who at the same time with standard treatments, capsules containing olive leaf extract (capsules with a dose of 250 mg twice a day for five days) olive leaf extract by Rose Daru Pharmaceutical Company in drug capsules of the same shape and size as other groups The intervention will be prepared and stored in conditions away from light and moisture. Intervention group: Patients who at the same time with standard treatments, capsules containing olive leaf extract (capsules with a dose of 500 mg twice a day for five days) olive leaf extract by Rose Daru Pharmaceutical Company in drug capsules of the same shape and size as other groups The intervention will be prepared and stored in conditions away from light and moisture. Control group: Patients who receive placebo at the same time as standard treatments in the form of capsules containing wheat flour twice a day for five days. The placebo will be stored by Rose Drug Pharmaceutical Company in drug capsules of the same shape and size as the other intervention groups prepared away from light and moisture. Arterial oxygen saturation. Timepoint: Before starting the intervention, then for five days twice a day from 6 am to 6 pm. Method of measurement: Medair pulse oximeter device. Heart rate. Timepoint: Before starting the intervention, then for five days twice a day from 6 am to 6 pm. Method of measurement: pulse oximeter device. Temperatures. Timepoint: Before starting the intervention, then for five days twice a day from 6 am to 6 pm. Method of measurement: Digital thermometer. Blood pressure. Timepoint: Before starting the intervention, then for five days twice a day from 6 am to 6 pm. Method of measurement: Hand pressure gauge. Complete blood count. Timepoint: Before and during the intervention on a daily basis. Method of measurement: Patient file. Severity of general symptoms of Covid-19 disease. Timepoint: Before and during the intervention on a daily basis. Method of measurement: Symptom Severity Questionnaire. Duration of hospitalization. Timepoint: Patient discharge time. Method of measurement: Counting the number of days the patient is hospitalized. Khoram-Abad University of Medical Sciences Approved 2021-02-15 Ethics committee of Lorestan University of Medical Sciences University of Medical Sciences, Shahid Anoushirvan Rezaei Square, Moallem St, Khorramabad Khorramabad Lorestan Iran (Islamic Republic of)