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IRCT20200404046937N3 IRCT 2020-06-25 Ahvaz University of Medical Sciences Evaluating the effect of Phyllanthus Emblica, Rosa Damascene, Marshmallow and Honey on COVID 19 The study of the effect of herbal drug Phyllanthus Emblica, Rosa Damascene, Althaea Officinalis and Honey in patient with covid 19 referring to Ahvaz Jundishapur university of Medical Science hospitals. 2020-06-27 anticipated 60 Complete https://irct.ir/trial/49029 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are divided into two Therapeutic groups by random method and used 6 blocks method. Individuals are the randomization unit and randomization tools are statistical soft ware, make a random sequence is by using statistical soft ware allocation concealment is by assigning unique codes, Blinding description: Double blind: Supervisor and the participants are blind to the prescription drug of the target group and the control group The drugs of both groups are distinguished in the same form. phyllanthus Emblica, Rosa damascene, Honey and Marshmallow have no significant smell and placebo will be the same color as the medicine by using allowed color. Also there is no significant difference between drug and placebo taste. The package are separated by mentioning the number. The list of numbers will be provided to the statistical consultant and then the data will be analyzed. 3 COVID 19. Intervention 1: Intervention group: Patients in the target group will receive the target group drug after treatment with routine medications. To prepare the target drug, 1000 g of Amla fruit is soaked in rose water and then ground, then combined with 500 g of rose petal powder, 500 g of marshmallow powder and 5 kg of honey, and the ingredients are carefully mixed together. Stir slowly to form a homogeneous composition and the final product is an oral concoction that is packaged in suitable 150 g storage cans and patients will want 5 g of this drug every 6 hours. Intervention 2: Control group: Patients will be treated with placebo after treatment with routine medications. To prepare a placebo, 3500 g of starch powder with 3500 g of sugar syrup are mixed well and with natural and authorized color, it is completely similar to the main medicine and then it is packed in 150 g packages and patients should take 5 g of medicine every 6 hours. 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 Mehran Varnaseri Ghandali
Razi hospital, Felestin Ave, Amanieh Ave
Ahvaz Iran (Islamic Republic of) 6196514941 +98 61 3333 7446 drvarnasseri.m@gmail.com Ahvaz University of Medical Sciences scientific Mehran Varnaseri Ghandali
Razi hospital, Felestin Ave, Amanieh ave
Ahvaz Iran (Islamic Republic of) 6196514941 +98 61 3333 7446 drvarnasseri.m@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Age ≥18 years Laboratory polymerase chain reaction (PCR) confirmed infection with COVID19 Lung involvement confirmed with chest imaging Hospitalized with: Fever or Respiratory rate >24/min Or Cough Less than 8 days since illness onset Willingness of study participant to accept randomization to any assigned treatment arm Acceptance of non-participation in another study before the 28th day of the study 18 years no limit Both Receipt of any experimental treatment for COVID 19 within the 30 days prior to the time of the screening evaluation Severe liver disease Known allergic reaction to drugs Severe renal disease Pregnant or breastfeeding women Transfer to another hospital within the next 72 hours U07.1 Corona virus infection, unspecified Treatment - Drugs Placebo Intervention group: Patients in the target group will receive the target group drug after treatment with routine medications. To prepare the target drug, 1000 g of Amla fruit is soaked in rose water and then ground, then combined with 500 g of rose petal powder, 500 g of marshmallow powder and 5 kg of honey, and the ingredients are carefully mixed together. Stir slowly to form a homogeneous composition and the final product is an oral concoction that is packaged in suitable 150 g storage cans and patients will want 5 g of this drug every 6 hours. Control group: Patients will be treated with placebo after treatment with routine medications. To prepare a placebo, 3500 g of starch powder with 3500 g of sugar syrup are mixed well and with natural and authorized color, it is completely similar to the main medicine and then it is packed in 150 g packages and patients should take 5 g of medicine every 6 hours. Viral diagnostic test. Timepoint: The first day of the study and the end of the study. Method of measurement: Polymerase chain reaction. Fever. Timepoint: Daily. Method of measurement: Thermometer. Chill. Timepoint: Daily. Method of measurement: Patients interview and patient file. Respiratory Rate. Timepoint: Daily. Method of measurement: Patients interview and patient file. Dyspnea. Timepoint: Daily. Method of measurement: Patients interview and patient file. Cough. Timepoint: Daily. Method of measurement: Patients interview and patient file. Body Pain. Timepoint: Daily. Method of measurement: Patients interview and patient file. Weakness. Timepoint: Daily. Method of measurement: Patients interview and patient file. Lymphocyte blood count. Timepoint: The first day of the study and the end of the. Method of measurement: Cell counter. C_reactive protein. Timepoint: The first day of the study and the end of the. Method of measurement: Agglutination Kit. Erythrocyte sedimentation Rate. Timepoint: The first day of the study and the end of the study. Method of measurement: Wester Green. Neutrophyle blood count. Timepoint: The first day of the study and the end of the study. Method of measurement: Cell counter. Platelet. Timepoint: The first day of the study and the end of the study. Method of measurement: Cell counter. Chest CT Scan. Timepoint: The first day of the study and the end of the study. Method of measurement: CT scan set. Ahvaz University of Medical Sciences Approved 2020-05-29 Ethics committee of Ahvaz University of Medical Ethics committee, main building, Ahvaz University of medical science, Golestan Ahvaz Khouzestan Iran (Islamic Republic of)