]>
IRCT20200405046960N2 IRCT 2020-05-19 Ardabil University of Medical Sciences Efficacy of Kelofan syrup on COVID-19 Evaluating efficacy of Kelofan syrup, a traditional Iranian medicine product on pulmonary & other clinical and laboratory manifestations of patients with or probable of covid-19 2020-05-17 anticipated 60 Complete https://irct.ir/trial/48126 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Samples will be randomly assigned to four blocks using Random Allocation Software. Blocking and allocation sequences for concealment will be done by the non-involved researcher (Allocation Concealment).The sample allocation ratio will be Allocation 1:1 and will be divided into two groups of receiving Iranian medicine products and control group (Assignment). Then based on blocks and allocation sequences medication will be given to patients, Blinding description: In this study, patients will be informed by consent form that they would either be in the intervention group or the control group, but they won't be aware of the type of medication. Nurses who supply the drug are also unaware of its content because the appearance, taste, color, and prescription of the drug are similar, but the code on the drug will be different. The written codes on the drugs are random and only the non-involved researcher is aware of the drug type and the inserted code on it. The patient data collector and the project statistical partner are also unaware of the type of intervention. As the control group uses placebo, which is similar in appearance, taste, color, and prescription, patients will be unaware of the type of drug being administered. 2-3 Condition 1: Covid-19. Condition 2: Covid-19. Intervention 1: Intervention group: In the intervention group, in addition to the standard treatment, medicinal herbal products will be prescribed.The drug will be given in syrup form. The syrup will contain the following medicinal herbs: Nepeta bracteata، Adiantum capillus veneris، Glycyrrhiza glabra, Foeniculum vulgare، Viola odorata, Ziziphus jujube, Malva sylvestris, Nigella sativa . The intervention group will receive 7.5 cc of Kelofan syrup every 12 hours one week. Intervention 2: Control group: This group receive routine treatments for COVID-19 disease and placebo. Placebo will be given as an oral syrup, two servings a day. For the placebo syrup, of stevia, authorized oral dyes are used to make the color and taste relatively similar to the original drug. 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 Ramin Nasimi Doost Azgomi
Ardabil University of Medical Sciences; Daneshgah street
Ardabil Iran (Islamic Republic of) 5618985991 +98 45 3142 2529 modir7060@yahoo.com Ardabil University of Medical Sciences scientific Ramin Nasimi Doost Azgomi
Ardabil University of Medical Sciences; Daneshgah street
Ardabil Iran (Islamic Republic of) 5618985991 +98 45 3142 2529 modir7060@yahoo.com Ardabil University of Medical Sciences Iran (Islamic Republic of) Patients over 18 years old Hospitalized patients withprobable or confirmed COVID-19 based on radiologicalfindings or positive PCR test according to the instructions22of the Ministry of Health Clinically classified as moderateand severe, no need for intubation Written and informedsatisfaction of patients 18 years no limit Both Liver, kidney and heart failure History of allergies to medicinal herbs Immunodeficiency Uncontrolled hypertension Uncontrolled diabetes Alcohol or drug addiction Patients with transplanted organs Cor Pulmonel Patients Takinganticoagulants, antiarrhythmics, antihypertensives, corticosteroids and immunosuppressants Pregnancy Breast feeding U07.1 U07.2 COVID19, virus identified COVID19, virus not identified Treatment - Drugs Placebo Intervention group: In the intervention group, in addition to the standard treatment, medicinal herbal products will be prescribed.The drug will be given in syrup form. The syrup will contain the following medicinal herbs: Nepeta bracteata، Adiantum capillus veneris، Glycyrrhiza glabra, Foeniculum vulgare، Viola odorata, Ziziphus jujube, Malva sylvestris, Nigella sativa . The intervention group will receive 7.5 cc of Kelofan syrup every 12 hours one week. Control group: This group receive routine treatments for COVID-19 disease and placebo. Placebo will be given as an oral syrup, two servings a day. For the placebo syrup, of stevia, authorized oral dyes are used to make the color and taste relatively similar to the original drug. Oxygen saturation. Timepoint: Clinical examination and Pulse Oximetry before starting intervention and regularly during hospitalized. Method of measurement: Pulse Oximeter. Respiratory Rate. Timepoint: Clinical examination before starting intervention and regularly during hospitalized. Method of measurement: Respiratory Count. C-reactive protein. Timepoint: Intravenous blood testing before starting intervention and during hospitalized. Method of measurement: Venous blood test. Lymphocytes. Timepoint: Intravenous blood testing before starting intervention and during hospitalized. Method of measurement: Venous blood test. White Cell blood count. Timepoint: Intravenous blood testing before starting intervention and during hospitalized. Method of measurement: Venous blood test. Liver enzymes. Timepoint: Intravenous blood testing before starting intervention and during hospitalized. Method of measurement: Venous blood test. Cough. Timepoint: Clinical examination before starting intervention and regularly during treatment. Method of measurement: Patient follow up. Fever. Timepoint: Clinical examination before starting intervention and regularly during treatment. Method of measurement: Thermometer. Ardabil University of Medical Sciences Approved 2020-04-05 Ethics committee of Ardabil University of Medical Sciences Ardabil University of Medical Sciences; Daneshgah street Ardabil Ardabil Iran (Islamic Republic of)