Protocol summary
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Study aim
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Assessment of the effect of Pinen.Hydronoplacton.Ribonucleic acid(PHR) spray in pulmonary problems of the patients with Covid-19
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Design
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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.
Study Phase:2-3.Blinding is not done.
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Settings and conduct
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In addition to the usual medicines for coronavirus, participants in the drug group take the spray for ten days and ten times daily (every hour, once). The control group only uses current medicine. The study site is Baqiyatallah Hospital.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:Male or female patients 18-65 years with COVID-19 confirmed by PCR and Ground glass view on CT scan.arterial oxygen saturation of less than 93%.completed informed consent
Exclusion criteria:pregnancy, ulcer or oral malignancy, history of pulmonary malignancy,history of asthma or COPD.
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Intervention groups
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The intervention groups will be two.In addition to the usual medicines for coronavirus, participants in intervention group take the spray .The control group only uses current medicine.
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Main outcome variables
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3D CT Scans
dyspnea
cough
arterial oxygen saturation
Respiratory Rate (RR)
CBC diff
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20160131026298N2
Registration date:
2020-04-20, 1399/02/01
Registration timing:
retrospective
Last update:
2025-01-04, 1403/10/15
Update count:
2
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Registration date
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2020-04-20, 1399/02/01
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-03-10, 1398/12/20
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Expected recruitment end date
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2020-03-15, 1398/12/25
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Actual recruitment start date
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2020-03-10, 1398/12/20
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Actual recruitment end date
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2020-03-15, 1398/12/25
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Trial completion date
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2020-03-24, 1399/01/05
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Scientific title
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Assessment of the effect of Pinen.Hydronoplacton.Ribonucleic acid (PHR) spray in pulmonary problems of the patients with Covid-19
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Public title
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The effect of PHR spray on patients with coronavirus-19
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
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
Exclusion criteria:
Oral ulcer or malignancy - history of pulmonary malignancy - history of asthma or COPD
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
64
Actual sample size reached:
64
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-03-10, 1398/12/20
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Ethics committee reference number
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IR.BMSU.REC.1398.387
Health conditions studied
1
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Description of health condition studied
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COVID-19
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ICD-10 code
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U07.2
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ICD-10 code description
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U07.2COVID-19, virus not identified, COVID-19
Primary outcomes
1
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Description
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Measurement of cough severity
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Timepoint
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Day 1 before and at the end of treatment
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Method of measurement
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Standard cough questionnaire
2
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Description
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severity of shortness of breath
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Timepoint
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Day 1 before and at the end of treatment
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Method of measurement
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Shortness Of Breath With Daily Activity (SOBDA) Questionnaire
3
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Description
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lung radiologic changes
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Timepoint
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At beginning and end of the study
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Method of measurement
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Chest CT scan
Secondary outcomes
1
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Description
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CBC Test
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Timepoint
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At beginning and end of the study
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Method of measurement
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Intravenous blood sampling and standard blood cell counter device
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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Control group: This group only uses current medicine (according to the Ministry of Health protocol) for the new corona virus.
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Category
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Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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www.taamasrar.com
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Proportion provided by this source
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10
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Other
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Questionnaires and related paraclinic tests in cases of discretion
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When the data will become available and for how long
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The next three to six months
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To whom data/document is available
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Approved faculty members and professors
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Under which criteria data/document could be used
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Use for spreading science and under legal terms and organizational guidelines
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From where data/document is obtainable
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Vice chancellor for research of university
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What processes are involved for a request to access data/document
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Send an email to the address of the Vice Chancellor for Research
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Comments
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Compliance with organizational requirements