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IRCT20200426047212N1 IRCT 2020-05-02 Shooshtar University of Medical Sciences Effect of of Inhalation of Thyme Oil in COVID-19 The Effect of Inhalation of Thyme Oil with Standard Nationwide Medication on Respiratory Markers and Laboratory Findings in Patients with COVID-19 2020-05-04 anticipated 48 Complete https://irct.ir/trial/47572 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Allocation of samples to each of the intervention and control groups was performed by block random method using 4 blocks. Random chains and concealment codes were generated by the website "www.sealedenvelope.com". To hide the random chain, the method of envelopes in non-transparent packages is also used, Blinding description: Thyme oil and placebo oil is imported in uniform bottles of the same color and is given to patients and clinical caregivers in envelopes A and B. Thyme oil does not have a special smell and using the allowed color, the placebo is the same color as the medicine. All research teams except the lead researcher and the treating physician will be blind, and the information will be given to the analyzer by the treating physician with a special code extracted from the table of random numbers. 2-3 COVID-19. Intervention 1: Intervention group: The intervention group in addition to receiving a standard nationwide medication [2 tablets of Hydroxychloroquine sulfate 200 mg as a single dose and 2 tablets of Kaletra(Lopinavir/Ritonavir) 200/200 mg every 12 hours], receives pure thyme oil every 8 hours (8 am, 4 pm, 12 pm) for 30 minutes through a nebulizer for 5 days. So that 4 drops of pure thyme oil with 10 cc of distilled water were prepared for each nebulization. Intervention 2: Control group: The control group in addition to receiving a standard nationwide medication [2 tablets of Hydroxychloroquine sulfate 200 mg as a single dose and 2 tablets of Kaletra(Lopinavir/Ritonavir) 200/200 mg every 12 hours], receives 10 cc of distilled water (placebo) every 8 hours (8 am, 4 pm, 12 pm) for 30 minutes through a nebulizer for 5 days. 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 Ali Hatami
Shahid Rajaei Ave., Al-Hadi Hospital, Education, Research, Cultural and Student Department of Shushtar Faculty of Medical Sciences
Shoushtar Iran (Islamic Republic of) 6451684534 +98 61 3622 8926 hatami_a@shoushtarums.ac.ir Shooshtar University of Medical Sciences scientific Mohammad Nikzadian
Shahid Rajaei Ave., Al-Hadi Hospital, Education, Research, Cultural and Student Department of Shushtar Faculty of Medical Sciences
Shoushtar Iran (Islamic Republic of) 6451684534 098 61 36228926 nikzadian-m@shoushtarums.ac.ir Shooshtar University of Medical Sciences Iran (Islamic Republic of) Age over 18 years Mild to moderate disease Positive polymerase chain reaction (PCR) test Lung involvement based on CT scan Hospitalization 18 years no limit Both Patient death Sensitivity to inhalation of the drug Intolerance of nebulizer Physician's diagnosis of not participating in the study Pregnancy and lactation Use of angiotensin-converting enzyme inhibitor Severe renal, hepatic, respiratory and cardiovascular failure Taking cytotoxic or corticosteroid drugs Transfer to another hospital U07.1 COVID-19, virus identified Treatment - Drugs Treatment - Drugs Intervention group: The intervention group in addition to receiving a standard nationwide medication [2 tablets of Hydroxychloroquine sulfate 200 mg as a single dose and 2 tablets of Kaletra(Lopinavir/Ritonavir) 200/200 mg every 12 hours], receives pure thyme oil every 8 hours (8 am, 4 pm, 12 pm) for 30 minutes through a nebulizer for 5 days. So that 4 drops of pure thyme oil with 10 cc of distilled water were prepared for each nebulization. Control group: The control group in addition to receiving a standard nationwide medication [2 tablets of Hydroxychloroquine sulfate 200 mg as a single dose and 2 tablets of Kaletra(Lopinavir/Ritonavir) 200/200 mg every 12 hours], receives 10 cc of distilled water (placebo) every 8 hours (8 am, 4 pm, 12 pm) for 30 minutes through a nebulizer for 5 days. Percentage of oxygen saturation. Timepoint: Before the start of the intervention, 5 consecutive days during the intervention and one day after the intervention. Method of measurement: Pulse oximeter. Respiratory rate. Timepoint: Before the start of the intervention, 5 consecutive days during the intervention and one day after the intervention. Method of measurement: Count the respiratory rate per minute. C-Reactive Protein. Timepoint: Before the intervention and one day in between during the intervention until discharge. Method of measurement: Venous blood test. White blood cell. Timepoint: Before the intervention and one day in between during the intervention until discharge. Method of measurement: Venous blood test. Neutrophil. Timepoint: Before the intervention and one day in between during the intervention until discharge. Method of measurement: Venous blood test. Lymphocytes. Timepoint: Before the intervention and one day in between during the intervention until discharge. Method of measurement: Venous blood test. Red blood count. Timepoint: Before the intervention and one day in between during the intervention until discharge. Method of measurement: Venous blood test. Erythrocyte sedimentation rate. Timepoint: Before the intervention and one day in between during the intervention until discharge. Method of measurement: Venous blood test. Shooshtar University of Medical Sciences Approved 2020-04-22 Ethics committee of Shoushtar Faculty of Medical Sciences Shahid Rajaei Ave., Al-Hadi Hospital, Education, Research, Cultural and Student Department of Shushtar Faculty of Medical Sciences Shoushtar Khouzestan Iran (Islamic Republic of)