Protocol summary
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Study aim
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Determining the effect of PHR160 (Pinen.Hydronoplacton.Ribonucleic acid )spray on improving lung function, severity and asthma attacks in patients with severe asthma
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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Determining the effect of PHR160 spray on improving lung function, severity and asthma attacks in patients with severe asthma
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Main outcome variables
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FEV1:FVC:FEF25-75:6MWD:Number of asthma attacks
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:
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
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Registration date
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2022-11-01, 1401/08/10
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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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2022-10-24, 1401/08/02
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Expected recruitment end date
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2022-12-23, 1401/10/02
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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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Public title
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Evaluation of PHR160 spray effect on improvement of severe asthmatic patients.
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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No age limit
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Gender
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Both
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Phase
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3
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Groups that have been masked
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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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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2022-02-01, 1400/11/12
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Ethics committee reference number
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IR.AJUMS.REC.1400.167
Health conditions studied
1
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Description of health condition studied
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Severe asthma
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ICD-10 code
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J45. 998
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ICD-10 code description
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J45. 998
Primary outcomes
1
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Description
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Quality of life score (based on quality of life questionnaire in asthmatic patients)
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Timepoint
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Before the intervention and one month later
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Method of measurement
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questionnaire
2
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Description
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The distance covered in the 6-minute walk test (in meters)
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Timepoint
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Before the intervention and one month later
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Method of measurement
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6-minute walking test
3
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Description
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Forced expiratory volume in the first second (FEV1)
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Timepoint
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Before the intervention and one month later
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Method of measurement
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spirometry
4
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Description
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Forced vital capacity (FVC)
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Timepoint
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Before the intervention and one month later
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Method of measurement
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spirometry
5
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Description
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forced expiratory flow 25%-75%
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Timepoint
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Before the intervention and one month later
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Method of measurement
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spirometry
6
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Description
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The number of exacerbations
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Timepoint
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Before the intervention and one month later
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Method of measurement
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Calculation of the number of exacerbations of the disease
Intervention groups
1
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Description
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Intervention group: PHR160 spray two puffs every eight hours for one month
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Category
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Treatment - Drugs
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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Yes
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Title of funding source
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Ahvaz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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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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Academic
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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No - There is not a plan to make this available
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Title and more details about the data/document
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All personal data of study participants can be shared after de-identification
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When the data will become available and for how long
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Access starts one month after results are published
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To whom data/document is available
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There is no access limit for people
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Under which criteria data/document could be used
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There is no access limit for people
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From where data/document is obtainable
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Dr. Hoda Mohseni Kia, Ahvaz University of Medical Sciences
medmosahneh@gmail.com
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What processes are involved for a request to access data/document
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Send the request to Dr. Mohseni Kia's email and it will be answered within a month
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Comments
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