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Recruitment centers
#1
Name of recruitment center - English: Baqiyatallah Hospital
Name of recruitment center - Persian: بیمارستان بقیه الله الأعظم (عج)
Full name of responsible person - English: Ahmad Reza Sharifi Olounabadi
Full name of responsible person - Persian: احمدرضا شریفی علون آبادی
Street address - English: Mulla Sadra Street, Vanak Square, After Sheikh Baha'i, Baqiyatallah Hospital
Street address - Persian: میدان ونک خیابان ملاصدرا بعد از شیخ بهایی بیمارستان بقیه الله الاعظم (عج)
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1435915371
Phone: +98 21 8805 0436
Fax:
Email: a-sharifi@shahed.ac.ir
Web page address:
Name of recruitment center - English: Baqiyatallah Hospital
Name of recruitment center - Persian: بیمارستان بقیه الله الأعظم (عج)
Full name of responsible person - English: Ahmad Reza Sharifi Olounabadi
Full name of responsible person - Persian: احمدرضا شریفی علون آبادی
Street address - English: Mulla Sadra Street, Vanak Square, After Sheikh Baha'i, Baqiyatallah Hospital
Street address - Persian: میدان ونک خیابان ملاصدرا بعد از شیخ بهایی بیمارستان بقیه الله الاعظم (عج)
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1435915371
Phone: +98 21 8805 0436
Fax:
Email: a-sharifi@bmsu.ac.ir
Web page address:
Name of recruitment center - English: Baqiyatallah Hospital Name of recruitment center - Persian: بیمارستان بقیه الله الأعظم (عج) Full name of responsible person - English: Ahmad Reza Sharifi Olounabadi Full name of responsible person - Persian: احمدرضا شریفی علون آبادی Street address - English: Mulla Sadra Street, Vanak Square, After Sheikh Baha'i, Baqiyatallah Hospital Street address - Persian: میدان ونک خیابان ملاصدرا بعد از شیخ بهایی بیمارستان بقیه الله الاعظم (عج) City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1435915371 Phone: +98 21 8805 0436 Fax: Email: a-sharifi@shahed.ac.irbmsu.ac.ir Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Gholamhosein Alishiri
Full name of responsible person - Persian: غلامحسین علیشیری
Street address - English: Baqiyatallah University, Third Floor, Vice-Chancellor for Research and Technology, Sheikh Bahai 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
Country: Iran (Islamic Republic of)
Postal code: 1435916471
Phone: +98 21 8755 5250
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: Gholamhosein Alishiri
Full name of responsible person - Persian: غلامحسین علیشیری
Street address - English: Baqiyatallah University, Third Floor, Vice-Chancellor for Research and Technology, Sheikh Bahai 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
Country: Iran (Islamic Republic of)
Postal code: 1435916471
Phone: +98 21 8755 5250
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: Gholamhosein Alishiri Full name of responsible person - Persian: غلامحسین علیشیری Street address - English: Baqiyatallah University, Third Floor, Vice-Chancellor for Research and Technology, Sheikh Bahai 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 Country: Iran (Islamic Republic of) Postal code: 1435916471 Phone: +98 21 8755 5250 Fax: Email: a-sharifi@shahed.ac.irbmsu.ac.ir Web page address:
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 scientific 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 - Seyed Hadi Hosseini
Full name of responsible person - Persian: احمدرضا شریفی علون آبادی - سید هادی حسینی
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 - Seyed Hadi Hosseini
Full name of responsible person - Persian: احمدرضا شریفی علون آبادی - سید هادی حسینی
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 - Seyed Hadi Hosseini Full name of responsible person - Persian: احمدرضا شریفی علون آبادی - سید هادی حسینی 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:
Protocol summary
Study aim
Assessment of the effect of Iranian medicine product, Nigle 7 capsule and black seed mixture , on the symptoms of patients with covid-19 (Coronavirus 19 disease)
Design
This clinical trial has control group, and with parallel groups, One-way blind, randomized, phase 2 to 3 and is performed on 80 patients. Randomization method will be blocked randomization (Quaternary random blocks).
Settings and conduct
Patients in the drug group take the Iranian traditional drug for ten days (three capsules a day and ten grams of black seed mixture daily). Patient in control group use routine treatment (According to the protocol of the Ministry of Health). The study is performed in Baqiyatallah Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Male or female patients 18 years old and older with COVID-19, Ground glass view at low-dose CT scan, Consciously completed consent form completed by the patient or the patient's supervisor. Exclusion criteria: History of pulmonary malignancy, History of asthma or COPD, History of Disabling disease or malignancy, Liver or kidney disorders.
Intervention groups
Intervention groups will be two ones.Patients in the intervention group will receive the intervention drug in addition to the routine treatment, but in control group, they will receive routine treatment.
Main outcome variables
3D lung CT Scans, dyspnea, cough, CBC diff
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160131026298N6
Registration date:2020-09-08, 1399/06/18
Registration timing:prospective
Last update:2020-11-01, 1399/08/11
Update count:2
Registration date
2020-09-08, 1399/06/18
Registrant information
Name
Ahmad Reza Sharifi Olounabadi
Name of organization / entity
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
2020-11-05, 1399/08/15
Expected recruitment end date
2021-03-20, 1399/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of Nigel-7 capsule and black seed mixture on COVID-19
Public title
Evaluation of the effectiveness of Nigel-7 capsule and black seed mixture on corona
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male or female patients 18 years old and older with Coronavirus Disease 2019 (COVID-19)
Ground glass view at low-dose CT scan
Consciously completed consent form completed by the patient or the patient's supervisor
Exclusion criteria:
History of pulmonary malignancy
History of asthma or COPD
History of Disabling disease or malignancy
Liver or kidney disorders
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method will be blocked randomization (Blocks of size 4). Randomization units are individuals. Eighty outpatients referred to the hospital emergency department are randomly assigned to one of the two intervention and control groups according to form of random string produced by online random allocation .
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
2020-03-29, 1399/01/10
Ethics committee reference number
IR.BMSU.REC.1399.157
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.2
ICD-10 code description
U07.2 COVID-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
Cough scoring form
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
empty
Intervention groups
1
Description
Intervention group: Intervention groups will be two ones. Patients in the intervention group will receive the intervention drug (three capsules a day and ten grams of black seed mixture daily) that is made by Talaye sabze tooba company; in addition to the routine treatment (Azithromycin 250 mg daily for 10 days and Naproxen 250 mg twice a day for 10 days) .
Category
Treatment - Drugs
2
Description
Control group: The control group will receive the routine treatment (Azithromycin 250 mg daily for 10 days and Naproxen 250 mg twice a day for 10 days) .
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatallah Hospital
Full name of responsible person
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@bmsu.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@bmsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
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
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 updating data
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Ahmad Reza Sharifi Olounabadi - Seyed Hadi Hosseini
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
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available