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IRCT20220610055122N1 IRCT 2022-11-01 Ahvaz University of Medical Sciences Evaluation of PHR160 spray effect on improvement of severe asthmatic patients. Evaluation of PHR160 spray effect on improvement of lung function, asthma severity and exacerbation in severe asthmatic patients. 2022-10-24 anticipated 60 Complete https://irct.ir/trial/66248 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 Severe asthma. Intervention group: PHR160 spray two puffs every eight hours for one month. Yes - There is a plan to make this available What will be shared: All personal data of study participants can be shared after de-identification When: Access starts one month after results are published To whom: There is no access limit for people Conditions: There is no access limit for people Where to obtain: Dr. Hoda Mohseni Kia, Ahvaz University of Medical Sciences medmosahneh@gmail.com How to obtain: Send the request to Dr. Mohseni Kia's email and it will be answered within a month Comments:
public Hoda Mohsenikia
Golestan farhang2 no51
Ahvaz Iran (Islamic Republic of) ۶۶۷۸۵۸۴۴۵۵ +98 61 4283 1367 medmosahneh@gmail.com Ahvaz University of Medical Sciences scientific mehrdad dargahi maal amir
Ahvaz, Farvardin Blvd., Golestan Hospital, Internal Department Office
Ahvaz Iran (Islamic Republic of) 6135733118 009833204501 dargahi.m@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients with severe asthma no limit no limit Both 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 J45. 998 J45. 998 Treatment - Drugs Intervention group: PHR160 spray two puffs every eight hours for one month 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. 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. Forced expiratory volume in the first second (FEV1). Timepoint: Before the intervention and one month later. Method of measurement: spirometry. Forced vital capacity (FVC). Timepoint: Before the intervention and one month later. Method of measurement: spirometry. Forced expiratory flow 25%-75%. Timepoint: Before the intervention and one month later. Method of measurement: spirometry. The number of exacerbations. Timepoint: Before the intervention and one month later. Method of measurement: Calculation of the number of exacerbations of the disease. Ahvaz University of Medical Sciences Approved 2022-02-01 Ethics Committee of Jundi Shapur Ahvaz University of Medical Sciences Ahvaz Golestan, Farvardin St., Golestan Hospital Ahvaz Khouzestan Iran (Islamic Republic of)