]>
IRCT20200809048337N1 IRCT 2022-11-29 Mazandaran University of Medical Sciences The effect of Mentha longifolia spray on patients with COVID-19 Explanation of Havay-e-Vabaie based on Iranian medicine and relation of it with epidemies. Determining the effect of the Iranian Medicine Product based on Mentha longifolia (nasal spray) on clinical and para clinical conditions of patients with COVID-19: clinical trial 2020-07-10 anticipated 60 Complete https://irct.ir/trial/50169 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After selecting the samples with inclusion criteria, the samples will be assigned to two groups using blocking. The random allocation process will be done with Randm allocation software. For this purpose, 10 blocks will be determined with this software and the block size is six. Based on this list, these samples are assigned to each of the intervention or control groups, respectively. 1-2 COVID-19. Intervention 1: Intervention group: included patients who have been admitted to the corona sections of Razi Hospital in Ghaemshahr with a definitive diagnosis of Covid 19. They are also eligible for inclusion in the study based on inclusion criteria. After the needed explanations by the assistant of Persian medicine or infectious disease physician assistant about the study and obtaining written consent, they enter the study and their information is recorded. In addition to routine medications, this group is also treated with Mentha longifolia spray. This spray is prepared in the Faculty of Pharmacy of Shahid Beheshti University. The product is made using a carbol with a concentration of 1.5% as a dilute gel with a pH: 6 to prevent mucosal damage. This group receives 2 puffs in each nostril, 15 minutes before breakfast and dinner, for 2 weeks in maximum. Before use, the drug must be examined and controlled in terms of microbial contamination . The prepared spray will be examined in terms of sterility in the microbiological laboratory of Shahid Beheshti School of Pharmacy. Intervention 2: Control group: includes patients who have been admitted to the corona sections of Razi Hospital in Ghaemshahr with a definitive diagnosis of Covid 19. They are also eligible for inclusion in the study based on inclusion criteria. After the needed explanations by the assistant of Persian medicine or infectious disease physician assistant about the study and obtaining written consent, they enter the study and their information is recorded. This group only receives routine medications. No intervention is made for this group. Only the necessary information will be recorded. Yes - There is a plan to make this available What will be shared: The items that can be shared are: The rate of reduction of patients' hospitalization Their clinical condition Their laboratory status Other related data When: The access period will be started 6 months after the results are published To whom: Researchers working in academic institutions and industrialist can send request to receive data. Conditions: Applicants must obtain written permission from the owners of the documents if they intend to use the documents commercially. Where to obtain: Dr. Mohammad Yousofpour Mazandaran University of Medical Sciences Postal Code: 4815733971 Phone: 00981133044426 Fax: 00981133044426 Email: m.yousofpoor@yahoo.com How to obtain: Sending a written request through the institution or the factory manager to the email of the first project executor Sending the necessary identification documents Checking in documents signing a memorandum of agreement Providing the required documentations to the applicant Comments:
public Yousofpour Mohammad
Hazrat Vali Asr Highway
Sari Iran (Islamic Republic of) 4815733971 +98 11 3304 4426 m.yousefpour@mazums.ac.ir Mazandaran University of Medical Sciences scientific Babam Mahmoodi Culture
Yousef Reza Street
Ghaemshahr city Iran (Islamic Republic of) 4815733971 +98 11 4221 8018 farhang.baba@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Patients who, have one / more of the following symptoms, in addition to acute respiratory illness (ARI):•RR> 30•PO2 <93% •Pulmonary infiltration in chest x-ray •Clinical judgment of a specialist physician 2- Age range of (18-75) years of both sexes 3- patient must not have any serious simultaneous heart, lung, brain and endocrine diseases 4- The patient's ability and personal desire to fill out a personal consent form to enter the study 18 years 75 years Both Pregnancy and breastfeeding Existence of any history of allergy to Mentha longifolia and its products patient's Inability to consume the oral form existence of any condition that prevents the continuing of the therapeutic intervention based on the physician's judgment Patient intubation Nausea and vomiting Resistant hypoxemia loss of consciousness Hemodynamic instability U07.1 Diseases of the respiratory system Treatment - Drugs N/A Intervention group: included patients who have been admitted to the corona sections of Razi Hospital in Ghaemshahr with a definitive diagnosis of Covid 19. They are also eligible for inclusion in the study based on inclusion criteria. After the needed explanations by the assistant of Persian medicine or infectious disease physician assistant about the study and obtaining written consent, they enter the study and their information is recorded. In addition to routine medications, this group is also treated with Mentha longifolia spray. This spray is prepared in the Faculty of Pharmacy of Shahid Beheshti University. The product is made using a carbol with a concentration of 1.5% as a dilute gel with a pH: 6 to prevent mucosal damage. This group receives 2 puffs in each nostril, 15 minutes before breakfast and dinner, for 2 weeks in maximum. Before use, the drug must be examined and controlled in terms of microbial contamination . The prepared spray will be examined in terms of sterility in the microbiological laboratory of Shahid Beheshti School of Pharmacy. Control group: includes patients who have been admitted to the corona sections of Razi Hospital in Ghaemshahr with a definitive diagnosis of Covid 19. They are also eligible for inclusion in the study based on inclusion criteria. After the needed explanations by the assistant of Persian medicine or infectious disease physician assistant about the study and obtaining written consent, they enter the study and their information is recorded. This group only receives routine medications. No intervention is made for this group. Only the necessary information will be recorded. Reduction of hospitalization rate. Timepoint: Daily. Method of measurement: Patient record. Respiratory rate. Timepoint: Daily. Method of measurement: By RR monitor or manual counting of breaths. Oxygen saturation. Timepoint: 8 am and 8 pm. Method of measurement: Pulsoximeter. Heart rate. Timepoint: twice a day. Method of measurement: By monitor or manually. Blood pressure measurement. Timepoint: Daily. Method of measurement: Mercury sphygmomanometer. Mazandaran University of Medical Sciences Approved 2020-05-12 Ethics Committee of Mazandaran University of Medical Sciences Hazrat Vali Asr Highway Sari Mazandaran Iran (Islamic Republic of) Approved 2020-05-12 National Research Ethics Committee. Qods Town Tehran Tehran Iran (Islamic Republic of)