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Person responsible for general inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Ahmad Reza Sharifi Olounabadi
Full name of responsible person - Persian: احمدرضا شریفی علون آبادی
Position - English: Assistant Professor
Position - Persian: استادیار
Latest degree: phd
Area of specialty/work: 58
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Vice-Chancellor for Research and Technology, Third Floor, Baqiyatallah University, Sheikh Bahaei St, Mulla Sadra St, Vanak Square
Street address - Persian: میدان ونک ، خ ملاصدرا ، خ شیخ بهایی، دانشگاه بقیه الله ، طبقه سوم ، معاونت تحقیقات و فن آوری
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1435916471
Phone: +98 21 8755 5250
Mobile: +98 913 366 0446
Fax:
Email: a-sharifi@shahed.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Ahmad Reza Sharifi Olounabadi
Full name of responsible person - Persian: احمدرضا شریفی علون آبادی
Position - English: Assistant Professor
Position - Persian: استادیار
Latest degree: phd
Area of specialty/work: 58
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Vice-Chancellor for Research and Technology, Third Floor, Baqiyatallah University, Sheikh Bahaei St, Mulla Sadra St, Vanak Square
Street address - Persian: میدان ونک ، خ ملاصدرا ، خ شیخ بهایی، دانشگاه بقیه الله ، طبقه سوم ، معاونت تحقیقات و فن آوری
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1435916471
Phone: +98 21 8755 5250
Mobile: +98 913 366 0446
Fax:
Email: a-sharifi@bmsu.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Ahmad Reza Sharifi Olounabadi Full name of responsible person - Persian: احمدرضا شریفی علون آبادی Position - English: Assistant Professor Position - Persian: استادیار Latest degree: phd Area of specialty/work: 58 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Vice-Chancellor for Research and Technology, Third Floor, Baqiyatallah University, Sheikh Bahaei St, Mulla Sadra St, Vanak Square Street address - Persian: میدان ونک ، خ ملاصدرا ، خ شیخ بهایی، دانشگاه بقیه الله ، طبقه سوم ، معاونت تحقیقات و فن آوری City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1435916471 Phone: +98 21 8755 5250 Mobile: +98 913 366 0446 Fax: Email: a-sharifi@shahed.ac.irbmsu.ac.ir Web page address:
Person responsible for updating data
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Ahmad Reza Sharifi Olounabadi
Full name of responsible person - Persian: احمد رضا شریفی علون آبادی
Position - English: Assistant Professor
Position - Persian: استادیار
Latest degree: phd
Area of specialty/work: 58
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Baqiyatallah University of Medical Sciences,Sheikh Bahai Street, Molla Sadra Street, Vanak Square
Street address - Persian: میدان ونک ، خ ملاصدرا ، خ شیخ بهایی، دانشگاه علوم پزشکی بقیه الله ، طبقه سوم ، معاونت تحقیقات و فن آوری
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1435916471
Phone: +98 21 8755 5253
Mobile: +98 913 366 0446
Fax:
Email: a-sharifi@shahed.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Ahmad Reza Sharifi Olounabadi
Full name of responsible person - Persian: احمد رضا شریفی علون آبادی
Position - English: Assistant Professor
Position - Persian: استادیار
Latest degree: phd
Area of specialty/work: 58
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Baqiyatallah University of Medical Sciences,Sheikh Bahai Street, Molla Sadra Street, Vanak Square
Street address - Persian: میدان ونک ، خ ملاصدرا ، خ شیخ بهایی، دانشگاه علوم پزشکی بقیه الله ، طبقه سوم ، معاونت تحقیقات و فن آوری
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1435916471
Phone: +98 21 8755 5253
Mobile: +98 913 366 0446
Fax:
Email: a-sharifi@bmsu.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Ahmad Reza Sharifi Olounabadi Full name of responsible person - Persian: احمد رضا شریفی علون آبادی Position - English: Assistant Professor Position - Persian: استادیار Latest degree: phd Area of specialty/work: 58 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Baqiyatallah University of Medical Sciences,Sheikh Bahai Street, Molla Sadra Street, Vanak Square Street address - Persian: میدان ونک ، خ ملاصدرا ، خ شیخ بهایی، دانشگاه علوم پزشکی بقیه الله ، طبقه سوم ، معاونت تحقیقات و فن آوری City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1435916471 Phone: +98 21 8755 5253 Mobile: +98 913 366 0446 Fax: Email: a-sharifi@shahed.ac.irbmsu.ac.ir Web page address:
Protocol summary
Study aim
Assessment of the effect of Pinen.Hydronoplacton.Ribonucleic acid(PHR) spray in pulmonary problems of the patients with Covid-19
Design
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.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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.
Intervention groups
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.
Baqiatallah University of Medical Science, Department of Traditional Iranian Medicine
Country
Iran (Islamic Republic of)
Phone
+98 21 8804 0060
Email address
a-sharifi@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-10, 1398/12/20
Expected recruitment end date
2020-03-15, 1398/12/25
Actual recruitment start date
2020-03-10, 1398/12/20
Actual recruitment end date
2020-03-15, 1398/12/25
Trial completion date
2020-03-24, 1399/01/05
Scientific title
Assessment of the effect of Pinen.Hydronoplacton.Ribonucleic acid (PHR) spray in pulmonary problems of the patients with Covid-19
Public title
The effect of PHR spray on patients with coronavirus-19
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
64
Actual sample size reached:
64
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Baqiyatallah University of Medical Sciences
Street address
Baqiyatallah University of Medical Sciences, Shahid Nosrati Alley, Shaikh Bahai St., Vanak Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2020-03-10, 1398/12/20
Ethics committee reference number
IR.BMSU.REC.1398.387
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.2
ICD-10 code description
U07.2COVID-19, virus not identified, COVID-19
Primary outcomes
1
Description
Measurement of cough severity
Timepoint
Day 1 before and at the end of treatment
Method of measurement
Standard cough questionnaire
2
Description
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
3
Description
lung radiologic changes
Timepoint
At beginning and end of the study
Method of measurement
Chest CT scan
Secondary outcomes
1
Description
CBC Test
Timepoint
At beginning and end of the study
Method of measurement
Intravenous blood sampling and standard blood cell counter device
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
Control group: This group only uses current medicine (according to the Ministry of Health protocol) for the new corona virus.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatallah Hospital
Full name of responsible person
REZAMOHTASHAMI; AHMAD REZA SHARIFI OLOUNABADI
Street address
Mulla Sadra Street, Vanak Square, After Sheikh Baha'i, Baqiyatallah Hospital
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8805 0436
Email
a-sharifi@shahed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Gholamhosein Alishiri
Street address
Baqiyatallah University, Third Floor, Vice-Chancellor for Research and Technology, Sheikh Bahai St, Mulla Sadra St,Vanak Square
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8755 5250
Email
a-sharifi@shahed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
www.taamasrar.com
Proportion provided by this source
10
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Ahmad Reza Sharifi Olounabadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Vice-Chancellor for Research and Technology, Third Floor, Baqiyatallah University, Sheikh Bahaei St, Mulla Sadra St, Vanak Square
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8755 5250
Email
a-sharifi@bmsu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Reza Mohtashami
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Baqiyatallah University of Medical Sciences,Sheikh Bahai Street, Molla Sadra Street, Vanak Square
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8755 5250
Email
reza_mohtashami1979@bmsu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Ahmad Reza Sharifi Olounabadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Baqiyatallah University of Medical Sciences,Sheikh Bahai Street, Molla Sadra Street, Vanak Square
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8755 5253
Email
a-sharifi@bmsu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Questionnaires and related paraclinic tests in cases of discretion
When the data will become available and for how long
The next three to six months
To whom data/document is available
Approved faculty members and professors
Under which criteria data/document could be used
Use for spreading science and under legal terms and organizational guidelines
From where data/document is obtainable
Vice chancellor for research of university
What processes are involved for a request to access data/document
Send an email to the address of the Vice Chancellor for Research