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IRCT20160131026298N2 IRCT 2020-04-20 Bagheiat-allah University of Medical Sciences The effect of PHR spray on patients with coronavirus-19 Assessment of the effect of Pinen.Hydronoplacton.Ribonucleic acid (PHR) spray in pulmonary problems of the patients with Covid-19 2020-03-10 anticipated 64 Complete https://irct.ir/trial/46733 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method is cluster randomization.Randomization units are hospitalized wards. First, two inpatient wards (capacity of each ward is 32 patients) are selected with similar conditions and, as two clusters, are randomly assigned to the intervention and control group. Referral to departments in the intervention group and control group is based on the patient's turn and is not related to the patient's condition or severity of the disease. patients admitting method in two wards will cause approximately similarities between two clusters before randomization. This study has no concealment and patients in the intervention group will receive the intervention medication in addition to the routine treatment, but in the control group they will only receive the routine treatment. 2-3 COVID-19. Intervention 1: Intervention group:The group uses the following herbal medicine in addition to the current medicine for Covid-19: Drug Name: Pinene-Hydronoplactone-Ribonucleoic-Abbreviation: PHR160 - Drug Form: Inhaler Spray --- Ingredients: Sineol Menthol Crocin Safranol Alpha Tojun Oleic Acid Linoleic Acid Linolenic AcidIt was extracted from natural products found in 7 plant species by steam distillation method. These herbs have previously had a single, double or triple human consumption history. Effectives per puff: 160 micrograms How to use PHR160: Determine the dosage approach for the above product based on the following: 1. Due to the volume of the nozzle output and pump MDIs and the presence of propylant (HFA gas) and alcohol in the product concentration of essential oils and herbal compounds in the total MDI is about 0.3%. Therefore, the total amount of soluble natural substances available per puff is less than 300 nL or 270 mg, which, of course, reaches a limited proportion in the lungs. 1-20 g / kg of human body weight and these compounds are considered very safe and high dosage is much lower than the toxic range indicated and is 1/100 toxic in the case of essential oils.3. Products available on the market such as Eucalyptus Barrage incense, Eucalyptus dyne incense Pulmonary doses of essential oils are similar to our product compounds in excess of 30mg. Of the amount in each puff investigated product is less than 1/100 of the amount above 0.4. External products mainly used in Aroma Therapy Ascents, MBC Aerosol, Primatene Mist are examples of those with higher doses of essential oil.5.Refruitment time to discuss the use or inhalation of the above product 30-45 In this case, the maximum time interval of 1 hour of awakening has been suggested for this product to reach the maximum dose possible with this product. Highly effective at the same time as the above dosage and the regimen, it was suggested to administer once per waking hour to be used in preliminary studies. It's the day. The spray was formulated by Jaber ebne Hayyan Pharmaceutical Company and the entire project is owned by the taam asrar Research Institute, Baqiyatallah University of Medical Sciences and Jaber Bin Hayan Pharmaceuticals. Intervention 2: Control group: This group only uses current medicine (according to the Ministry of Health protocol) for the new corona virus. Yes - There is a plan to make this available What will be shared: Questionnaires and related paraclinic tests in cases of discretion When: The next three to six months To whom: Approved faculty members and professors Conditions: Use for spreading science and under legal terms and organizational guidelines Where to obtain: Vice chancellor for research of university How to obtain: Send an email to the address of the Vice Chancellor for Research Comments: Compliance with organizational requirements
public Ahmad Reza Sharifi Olounabadi
Vice-Chancellor for Research and Technology, Third Floor, Baqiyatallah University, Sheikh Bahaei St, Mulla Sadra St, Vanak Square
Tehran Iran (Islamic Republic of) 1435916471 +98 21 8755 5250 a-sharifi@bmsu.ac.ir Bagheiat-allah University of Medical Sciences scientific Reza Mohtashami
Baqiyatallah University of Medical Sciences,Sheikh Bahai Street, Molla Sadra Street, Vanak Square
Tehran Iran (Islamic Republic of) 1435916471 +98 21 8755 5250 reza_mohtashami1979@bmsu.ac.ir Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Male or female patients 18-65 years with COVID-19 confirmed by PCR (with mild involvement) - Ground glass view on CT scan - Arterial oxygen saturation less than 93% - Breathing more than 24 times per minute - At the Beginning onset of the disease - Negative pregnancy test in women - Completion of informed consent form by patient or supervisor 18 years 65 years Both Oral ulcer or malignancy - history of pulmonary malignancy - history of asthma or COPD U07.2 U07.2COVID-19, virus not identified, COVID-19 Treatment - Drugs Other Intervention group:The group uses the following herbal medicine in addition to the current medicine for Covid-19: Drug Name: Pinene-Hydronoplactone-Ribonucleoic-Abbreviation: PHR160 - Drug Form: Inhaler Spray --- Ingredients: Sineol Menthol Crocin Safranol Alpha Tojun Oleic Acid Linoleic Acid Linolenic AcidIt was extracted from natural products found in 7 plant species by steam distillation method. These herbs have previously had a single, double or triple human consumption history. Effectives per puff: 160 micrograms How to use PHR160: Determine the dosage approach for the above product based on the following: 1. Due to the volume of the nozzle output and pump MDIs and the presence of propylant (HFA gas) and alcohol in the product concentration of essential oils and herbal compounds in the total MDI is about 0.3%. Therefore, the total amount of soluble natural substances available per puff is less than 300 nL or 270 mg, which, of course, reaches a limited proportion in the lungs. 1-20 g / kg of human body weight and these compounds are considered very safe and high dosage is much lower than the toxic range indicated and is 1/100 toxic in the case of essential oils.3. Products available on the market such as Eucalyptus Barrage incense, Eucalyptus dyne incense Pulmonary doses of essential oils are similar to our product compounds in excess of 30mg. Of the amount in each puff investigated product is less than 1/100 of the amount above 0.4. External products mainly used in Aroma Therapy Ascents, MBC Aerosol, Primatene Mist are examples of those with higher doses of essential oil.5.Refruitment time to discuss the use or inhalation of the above product 30-45 In this case, the maximum time interval of 1 hour of awakening has been suggested for this product to reach the maximum dose possible with this product. Highly effective at the same time as the above dosage and the regimen, it was suggested to administer once per waking hour to be used in preliminary studies. It's the day. The spray was formulated by Jaber ebne Hayyan Pharmaceutical Company and the entire project is owned by the taam asrar Research Institute, Baqiyatallah University of Medical Sciences and Jaber Bin Hayan Pharmaceuticals. Control group: This group only uses current medicine (according to the Ministry of Health protocol) for the new corona virus. Measurement of cough severity. Timepoint: Day 1 before and at the end of treatment. Method of measurement: Standard cough questionnaire. Severity of shortness of breath. Timepoint: Day 1 before and at the end of treatment. Method of measurement: Shortness Of Breath With Daily Activity (SOBDA) Questionnaire. Lung radiologic changes. Timepoint: At beginning and end of the study. Method of measurement: Chest CT scan. CBC Test. Timepoint: At beginning and end of the study. Method of measurement: Intravenous blood sampling and standard blood cell counter device. www.taamasrar.com Approved 2020-03-10 Ethics Committee of Baqiyatallah University of Medical Sciences Baqiyatallah University of Medical Sciences, Shahid Nosrati Alley, Shaikh Bahai St., Vanak Square, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)