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IRCT20200404046937N1 IRCT 2020-04-09 Ahvaz University of Medical Sciences Evaluating the effect of Marshmallow and Licorice on COVID 19 patients Evaluating the therapeutic effect of a mixed herbal drink of Marshmallow and Licorice on COVID 19 patients, A double blind clinical trial 2020-04-09 anticipated 60 Complete https://irct.ir/trial/46903 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(aluminium package). Licorice 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:After routine treatment , the main group will be received the drug of the study . drugs are in the sacher form. every sacher contain 2.5 gram of Marshmallow and 2.5 gram of Licorice. For 10 days Patients should infuse the contents of one packet with 250 cc of boiling water for 10 minutes every 12 hours, then strain and sip. Intervention 2: Control group: after routine treatment, the control group willl be received the placebo. they are in the sacher form. The contents of each package of placebo is 5 grams of starch powder. For 10 days, patients should infuse the contents of one packet with 250 cc of boiling water for 12 minutes every 12 hours, then strain and sip. 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 Dr.varnaseri@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 Dr.varnaseri@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 (axillar or oral temperature ≥ 38.0 °centigrade(C) or ≥38.6°centigrade tympanic or rectal) 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 Physician makes a decision that trial involvement is not in patients' best interest, or any condition that does not allow the protocol to be followed safely. Severe liver disease Oxygen saturation≤94% Known allergic reaction to Marshmallow or Licorice Severe renal impairment Pregnant or breastfeeding women Transfer to another non-study hospital within the next 72 hours Receipt of any experimental treatment for COVID 19 within the 30 days prior to the time of the screening evaluation. Angiotensin converting enzyme (ACE) inhibitor users Hypertensive patients U07.1 Corona virus infection, unspecified Treatment - Drugs Placebo Intervention group:After routine treatment , the main group will be received the drug of the study . drugs are in the sacher form. every sacher contain 2.5 gram of Marshmallow and 2.5 gram of Licorice. For 10 days Patients should infuse the contents of one packet with 250 cc of boiling water for 10 minutes every 12 hours, then strain and sip Control group: after routine treatment, the control group willl be received the placebo. they are in the sacher form. The contents of each package of placebo is 5 grams of starch powder. For 10 days, patients should infuse the contents of one packet with 250 cc of boiling water for 12 minutes every 12 hours, then strain and sip. Viral diagnostic test. Timepoint: The first day of the study and the end of the study (10th day). Method of measurement: Polymerase chain reaction. Fever. Timepoint: The first day of the study and the end of the study (10th day). Method of measurement: Thermometer. Chill. Timepoint: The first day of the study and the end of the study (10th day). Method of measurement: Patients interview and patient file. Cough. Timepoint: The first day of the study and the end of the study (10th day). Method of measurement: Patients interview and patient file. Dyspnea. Timepoint: The first day of the study and the end of the study (10th day). Method of measurement: Patients interview and patient file. Lymphocyte blood count. Timepoint: The first day of the study and the end of the study (10th day). Method of measurement: Cell counter. C_reactive protein. Timepoint: The first day of the study and the end of the study (10th day). Method of measurement: Agglutination kit. Chest X ray. Timepoint: The first day of the study and the end of the study (10th day). Method of measurement: Radiology set. Chest CT scan. Timepoint: The first day of the study and the end of the study (10th day). Method of measurement: CT scan set. Ahvaz University of Medical Sciences Approved 2020-04-04 Ethics committee of Ahvaz University of Medical Ethics committee, main building, Ahvaz university of medical science, Golestan Ahvaz Khouzestan Iran (Islamic Republic of)