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IRCT20231030059905N1 IRCT 2024-01-21 Bojnourd University of Medical Sciences Investigating the effect of peppermint essential oil inhalation on improving lung function in patients with asthma Investigating the effect of inhalation and nebulization of peppermint plant essence on improving lung function in patients with asthma referred to a medical clinic 2023-12-22 anticipated 48 Complete https://irct.ir/trial/73517 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The division is done based on block randomization. Eligible patients will be randomly assigned using permuted blocked randomization (1:1) with a block size of 4 into two groups: an intervention group receiving inhalation (nebulizer) of peppermint plant essential oil and a placebo group. The order of blocks will also be randomized. According to the permuted blocked randomization scheme of the study, the whole randomization list will be created before a single patient is enrolled. Then, the prepared list will be numbered from the beginning of the list. The assignment of numbers to the study groups will be kept confidential and not shared with the research team. Therefore, with this numbering, the research team involved in the intervention process will be blinded to the allocated treatment. These numbers will be also included in the pockets of inhalation (nebulizer) of peppermint plant essential oil and its placebo. Upon randomization into the trial, patients will receive the next sequential assignment based on the randomization list, Blinding description: The researchers will try to blind the medical team involved in the entire interventional process for the allocated treatment. However, as the essential oil has its special odor, the blinding will not be perfect. This will be mentioned in the limitations of the relevant paper. Eligible patients will be randomly assigned using permuted blocked randomization (1:1) with a block size of 4 into two groups: an intervention group receiving inhalation (nebulizer) of peppermint plant essential oil and a placebo group. The order of blocks will also be randomized. According to the permuted blocked randomization scheme of the study, the whole randomization list will be created before a single patient is enrolled. Then, the prepared list will be numbered from the beginning of the list. The assignment of numbers to the study groups will be kept confidential and not shared with the research team. Therefore, with this numbering, the research team involved in the intervention process will be blinded to the allocated treatment. These numbers will be also included in the pockets of inhalation (nebulizer) of peppermint plant essential oil and its placebo. Upon randomization into the trial, patients will receive the next sequential assignment based on the randomization list. 3 Asthma disease, patients with grade 2 and 3 asthma. Intervention 1: Intervention group: women and men with grade 2 and 3 asthma diagnosed by a specialist doctor. Age range from 18 to 65 years. Without allergic symptoms and acute respiratory disease. People did not use anti-asthma drugs 6 hours before spirometry, and these patients were given 1.4 ml of peppermint essence (mint solution and ethanol). After 15 to 30 minutes of peppermint essential oil nebulization, FEV1 to FVC level is again measured and recorded. Intervention 2: Control group: women and men with grade 2 and 3 asthma diagnosed by a specialist doctor. Age range from 18 to 65 years. No allergic symptoms and acute respiratory disease. This group will receive placebo (ethanol and distilled water) and according to the block randomization system, other cases that were done in the intervention group will also be done on this group. Yes - There is a plan to make this available What will be shared: Demographic information form, informed consent, evaluations before and after the study and clinical trial, trial results, analysis table are shared at the end of the study. When: Access 6 months after printing the results To whom: Qualified researchers Conditions: Just to monitor and also help in scientific promotion . After getting approval from the first author and the project consultant Where to obtain: First author and project consultant How to obtain: Getting written approval from the first author and the person in charge and consultant of the project Comments:
public Dr Ali Haghbin
Dolat Blvd., Central Building of North Khorasan University of Medical Sciences, Bojnoord
Bojnourd Iran (Islamic Republic of) 74877-94149 +98 58 3151 0000 INFO@NKUMS.AC.IR Bojnourd University of Medical Sciences scientific Dr Ali Haghbin
Dolat Blvd., Central Building of North Khorasan University of Medical Sciences, Bojnoord
Bojnourd Iran (Islamic Republic of) 74877-94149 +98 58 3151 0000 INFO@NKUMS.AC.IR Bojnourd University of Medical Sciences Iran (Islamic Republic of) Patients with level 2 or 3 asthma who have visited the clinic and have no acute respiratory problems 18 years 65 years Both Measuring sensitivity to mint (one of the exit criteria): by taking a history of the symptoms of an allergic reaction to mint (itching, hives, shortness of breath). Lack of personal satisfaction Lack of bronchodilator-responsive asthma High grades of asthma with clinical symptoms such as chronic and severe shortness of breath J45 Asthma Treatment - Drugs Placebo Intervention group: women and men with grade 2 and 3 asthma diagnosed by a specialist doctor. Age range from 18 to 65 years. Without allergic symptoms and acute respiratory disease. People did not use anti-asthma drugs 6 hours before spirometry, and these patients were given 1.4 ml of peppermint essence (mint solution and ethanol). After 15 to 30 minutes of peppermint essential oil nebulization, FEV1 to FVC level is again measured and recorded. Control group: women and men with grade 2 and 3 asthma diagnosed by a specialist doctor. Age range from 18 to 65 years. No allergic symptoms and acute respiratory disease. This group will receive placebo (ethanol and distilled water) and according to the block randomization system, other cases that were done in the intervention group will also be done on this group. The amount of air that leaves the lungs during the first second of forced exhalation(FEV1). Timepoint: Measurement of variables in both control and control groups, before the start of the study, half an hour after inhaling the essential oil. Method of measurement: Spirometry, feNO test, demographic information is completed by questionnaire. FVC. Timepoint: Measurement of variables in both control and control groups, before the start of the study, half an hour after inhaling the essential oil. Method of measurement: Spirometry. The ratio of FEV1 to FVC. Timepoint: Measurement of variables in both control and control groups, before the start of the study, half an hour after inhaling the essential oil. Method of measurement: Spirometry. The amount of peppermint essential oil. Timepoint: Measurement of variables in both control and control groups, before the start of the study, half an hour after inhaling the essential oil. Method of measurement: ml. ِِِِِDemographic information. Timepoint: Before starting the study. Method of measurement: Examining patients' files and asking the patient or his companion. Improve lung function. Timepoint: Immediately 15 to 30 minutes after inhalation. Method of measurement: FVC , FVC, The ratio of FEV1 to FVC. Bojnourd University of Medical Sciences Approved 2023-11-19 Research Ethics Committees of North Khorasan University of Medical Sciences Bojnourd , chamran str , chamran36 Bojnourd North Khorasan Iran (Islamic Republic of)