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Evaluation of PHR160 spray effect on improvement of lung function, asthma severity and exacerbation in severe asthmatic patients.

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History
# Registration date Revision Id
2 2022-11-27, 1401/09/06 249170
1 2022-11-01, 1401/08/10 244417
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  • Recruitment centers

    #1
    Name of recruitment center - English: Imam Khomeini Hospital of Ahvaz
    Name of recruitment center - Persian: بیمارستان امام خمینی اهواز
    Full name of responsible person - English: mehrdad dargahi
    Full name of responsible person - Persian: مهرداد درگاهی
    Street address - English: Imam Khomeini Hospital, Azadegan Street, Ahvaz
    Street address - Persian: اهواز خیابان آزادگان بیمارستان امام خمینی
    City - English: Ahvaz
    City - Persian: اهواز
    Province: Khouzestan
    Country: Iran (Islamic Republic of)
    Postal code: 6135733118
    Phone: +98 61 3222 2818
    Fax:
    Email: medmosahneh@gmail.com
    Web page address:
    Name of recruitment center - English: Imam Khomeini Hospital of Ahvaz
    Name of recruitment center - Persian: بیمارستان امام خمینی اهواز
    Full name of responsible person - English: mehrdad dargahi maal amir
    Full name of responsible person - Persian: مهرداد درگاهی مال امیر
    Street address - English: Imam Khomeini Hospital, Azadegan Street, Ahvaz
    Street address - Persian: اهواز خیابان آزادگان بیمارستان امام خمینی
    City - English: Ahvaz
    City - Persian: اهواز
    Province: Khouzestan
    Country: Iran (Islamic Republic of)
    Postal code: 6193673166
    Phone: +98 61 3222 2818
    Fax:
    Email: dr_mehrdad_dargahi@yahoo.com
    Web page address:
    #2
    Name of recruitment center - English: Golestan Hospital Ahvaz
    Name of recruitment center - Persian: بیمارستان گلستان اهواز
    Full name of responsible person - English: mehrdad dargahi
    Full name of responsible person - Persian: مهرداد درگاهی
    Street address - English: Golestan Hospital Farvardin Street Ahvaz
    Street address - Persian: اهواز خیابان فروردین بیمارستان گلستان
    City - English: ahvaz
    City - Persian: اهواز
    Province: Khouzestan
    Country: Iran (Islamic Republic of)
    Postal code: 6135733118
    Phone: +98 61 3320 4501
    Fax:
    Email: Golestanjpspital@yahoo.com
    Web page address:
    Name of recruitment center - English: Golestan Hospital Ahvaz
    Name of recruitment center - Persian: بیمارستان گلستان اهواز
    Full name of responsible person - English: mehrdad dargahi maal amir
    Full name of responsible person - Persian: مهرداد درگاهی مال امیر
    Street address - English: Golestan Hospital Farvardin Street Ahvaz
    Street address - Persian: اهواز خیابان فروردین بیمارستان گلستان
    City - English: ahvaz
    City - Persian: اهواز
    Province: Khouzestan
    Country: Iran (Islamic Republic of)
    Postal code: 6135733118
    Phone: +98 61 3320 4501
    Fax:
    Email: dr_mehrdad_dargahi@yahoo.com
    Web page address:

  • Person responsible for general inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: mehrdad dargahi
    Full name of responsible person - Persian: مهرداد درگاهی
    Position - English: Associate Professor
    Position - Persian: دانشیار
    Latest degree: sub_specialist
    Area of specialty/work: 40
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Ahvaz, Farvardin Blvd., Golestan Hospital, Internal Department Office
    Street address - Persian: اهواز بلوار فروردین بیمارستان گلستان دفتر گروه داخلی
    City - English: Ahvaz
    City - Persian: اهواز
    Province: Khouzestan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 6135733118
    Phone: +98 61 3320 4501
    Mobile: +98 916 612 6311
    Fax:
    Email: dargahi.m@ajums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Hoda Mohsenikia
    Full name of responsible person - Persian: هدی محسنی کیا
    Position - English: Resident
    Position - Persian: رزیدنت
    Latest degree: med_doctor
    Area of specialty/work: 40
    Area of specialty/work title - English: Internal medicine
    Area of specialty/work title - Persian: بیماری های دخلی
    Street address - English: Golestan farhang2 no51
    Street address - Persian: گلستان خیابان فرهنگ دو مجتمع افتاب پلاک51
    City - English: Ahvaz
    City - Persian: اهواز
    Province: Khouzestan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: ۶۶۷۸۵۸۴۴۵۵
    Phone: +98 61 4283 1367
    Mobile: +98 916 340 9681
    Fax:
    Email: medmosahneh@gmail.com
    Web page address:

  • Person responsible for scientific inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: mehrdad dargahi
    Full name of responsible person - Persian: مهرداد درگاهی
    Position - English: Associate professor
    Position - Persian: دانشیار
    Latest degree: sub_specialist
    Area of specialty/work: 40
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Ahvaz, Farvardin Blvd., Golestan Hospital, Internal Department Office
    Street address - Persian: اهواز خیابان فروردین بیمارستان گلستان دفتر گروه داخلی
    City - English: Ahvaz
    City - Persian: اهواز
    Province: Khouzestan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 6135733118
    Phone: 009833204501
    Mobile: +98 916 612 6311
    Fax:
    Email: dargahi.m@ajums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: mehrdad dargahi maal amir
    Full name of responsible person - Persian: مهرداد درگاهی مال امیر
    Position - English: professor
    Position - Persian: استادیار
    Latest degree: sub_specialist
    Area of specialty/work: 40
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Ahvaz, Farvardin Blvd., Golestan Hospital, Internal Department Office
    Street address - Persian: اهواز خیابان فروردین بیمارستان گلستان دفتر گروه داخلی
    City - English: Ahvaz
    City - Persian: اهواز
    Province: Khouzestan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 6135733118
    Phone: 009833204501
    Mobile: +98 916 612 6311
    Fax:
    Email: dargahi.m@ajums.ac.ir
    Web page address:

Protocol summary

Study aim
Determining the effect of PHR160 (Pinen.Hydronoplacton.Ribonucleic acid )spray on improving lung function, severity and asthma attacks in patients with severe asthma
Design
A clinical trial with a control group and a placebo group, parallel, one-sided blind, randomized, the study was conducted on 60 patients and a table of random numbers was used for randomization.
Settings and conduct
The studied patients are selected from among those who refer to the lung clinic of Imam Khomeini Hospital in Ahvaz, Golestan Hospital in Ahvaz, or the personal office of Jundishapour University Pulmonary Doctors in Ahvaz.
Participants/Inclusion and exclusion criteria
including criteria is patients with severe asthma.exclusing criteria is history of reflux, sinusitis, allergic rhinitis, as well as patients with advanced liver and kidney failure, pregnant, or a history of allergy or contraindication to the use of herbal compounds such as menthone, saffron, crocin and Safranel
Intervention groups
Determining the effect of PHR160 spray on improving lung function, severity and asthma attacks in patients with severe asthma
Main outcome variables
FEV1:FVC:FEF25-75:6MWD:Number of asthma attacks

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220610055122N1
Registration date: 2022-11-01, 1401/08/10
Registration timing: registered_while_recruiting

Last update: 2022-12-16, 1401/09/25
Update count: 1
Registration date
2022-11-01, 1401/08/10
Registrant information
Name
hoda mohsenikia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 4283 1367
Email address
medmosahneh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-24, 1401/08/02
Expected recruitment end date
2022-12-23, 1401/10/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of PHR160 spray effect on improvement of lung function, asthma severity and exacerbation in severe asthmatic patients.
Public title
Evaluation of PHR160 spray effect on improvement of severe asthmatic patients.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with severe asthma
Exclusion criteria:
pregnancy history of reflux history of sinusitis History of allergic rhinitis History of advanced liver and kidney failure Allergy and contraindications of herbal compounds such as menthone, saffron, crocin, safranel
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Using a calculator, random numbers from 1 to 60 were generated, thirty numbers and the first number generated by the calculator were assigned to the intervention group and the next number to the control group, then the package of drugs was assigned from 1 to 60 in order. It was given to the researcher to prescribe to the patients.
Blinding (investigator's opinion)
Double blinded
Blinding description
All sprays were in the same package, a number label was on the spray box. Only the pharmacist was aware of the number assigned to the relevant group. Then, in order from number 1 to 60, the package of drugs was given to the researcher to prescribe to the patients.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Jundi Shapur Ahvaz University of Medical Sciences
Street address
Ahvaz Golestan, Farvardin St., Golestan Hospital
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2022-02-01, 1400/11/12
Ethics committee reference number
IR.AJUMS.REC.1400.167

Health conditions studied

1

Description of health condition studied
Severe asthma
ICD-10 code
J45. 998
ICD-10 code description
J45. 998

Primary outcomes

1

Description
Quality of life score (based on quality of life questionnaire in asthmatic patients)
Timepoint
Before the intervention and one month later
Method of measurement
questionnaire

2

Description
The distance covered in the 6-minute walk test (in meters)
Timepoint
Before the intervention and one month later
Method of measurement
6-minute walking test

3

Description
Forced expiratory volume in the first second (FEV1)
Timepoint
Before the intervention and one month later
Method of measurement
spirometry

4

Description
Forced vital capacity (FVC)
Timepoint
Before the intervention and one month later
Method of measurement
spirometry

5

Description
forced expiratory flow 25%-75%
Timepoint
Before the intervention and one month later
Method of measurement
spirometry

6

Description
The number of exacerbations
Timepoint
Before the intervention and one month later
Method of measurement
Calculation of the number of exacerbations of the disease

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: PHR160 spray two puffs every eight hours for one month
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital of Ahvaz
Full name of responsible person
mehrdad dargahi maal amir
Street address
Imam Khomeini Hospital, Azadegan Street, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61 3222 2818
Email
dr_mehrdad_dargahi@yahoo.com

2

Recruitment center
Name of recruitment center
Golestan Hospital Ahvaz
Full name of responsible person
mehrdad dargahi maal amir
Street address
Golestan Hospital Farvardin Street Ahvaz
City
ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3320 4501
Email
dr_mehrdad_dargahi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Vice President of Research and Technology of Jundishapur University of Medical Sciences, Ahvaz
Street address
Golestan Blvd., University City, Esfand St., Jundishapur University of Medical Sciences, Ahvaz, Vice President of Research and Technology Development
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 0000
Email
journal_ajums@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Hoda Mohsenikia
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Golestan farhang2 no51
City
Ahvaz
Province
Khouzestan
Postal code
۶۶۷۸۵۸۴۴۵۵
Phone
+98 61 4283 1367
Fax
Email
medmosahneh@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
mehrdad dargahi maal amir
Position
professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Ahvaz, Farvardin Blvd., Golestan Hospital, Internal Department Office
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
009833204501
Email
dargahi.m@ajums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
hoda mohsenikia
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Ahvaz, Farvardin Blvd., Golestan Hospital, Internal Department Office
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3320 4501
Email
medmosahneh@gmail.com

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
No - There is not a plan to make this available
Title and more details about the data/document
All personal data of study participants can be shared after de-identification
When the data will become available and for how long
Access starts one month after results are published
To whom data/document is available
There is no access limit for people
Under which criteria data/document could be used
There is no access limit for people
From where data/document is obtainable
Dr. Hoda Mohseni Kia, Ahvaz University of Medical Sciences medmosahneh@gmail.com
What processes are involved for a request to access data/document
Send the request to Dr. Mohseni Kia's email and it will be answered within a month
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