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IRCT201209302695N4 IRCT 2015-04-29 Islamic Azad University of Mashhad Effect of Propolis on moderate asthma Effect of Propolis on clinical and physiological parameters of moderate Asthma. A double blind randomized placebo- controlled clinical trial. 2014-12-28 anticipated 50 Complete https://irct.ir/trial/2497 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: All recruited asthmatic subjects will randomly divided into two groups (Propolis and placebo) by computer generated randomization list. The physician and pharmacist are blind to the exact drug. Propolis and placebo will be packed in bottle with similar appearance and they will get code according to the randomization schedule. 2 asthma. Intervention 1: Moderate stage asthmatic subjects whom were not previously treated will be evaluated for clinical findings, spirometry, asthma control test, FENO, sputum cytology, IL-4 ، IFN-γ ، IL-17 and TLR-2 at the onset of the study. The subjects will be randomly divided in to two groups. Package of propolis and placebo will be produced in similar appearance and case group will recieve a pack ot Propolis which each pack contains 21 pills and each pill contains 125 mg. The package will get coded base on the random number table by a third person whom will be blind to groups. The code will be saved when the drug gives to the patient. The physician and pharmacist will blind to the codes. The subjects will follow during three weeks period of treatment by telephone call for assessing the side effects and exacerbation of symptoms. Emergency usage of Salbutamol inhaler will be permitted as needed. After 3 weeks the mentioned assessment will be repeated. Intervention 2: Control group: Moderate stage asthmatic subjects who randomly allocated in control group will be evaluated for clinical findings, spirometry, asthma control test, FENO, sputum cytology, IL-4 ، IFN-γ ، IL-17 and TLR-2 as the same as trial group. Package of propolis and placebo will produce in similar appearance and in this group the pack contains 21 placebo pills. The package will get coded base on the random number table by a third person who will be blind to groups. The physician and pharmacist will keep blind to the codes. The subjects will follow during three weeks period of treatment by telephone call for assessing the side effects and exacerbation of symptoms. Emergency usage of Salbutamol inhaler will be permitted as needed. After 3 weeks the mentioned assessment will be repeated. Introduction: Propolis is produced by honey bee, but it seems that its constituent is different from honey. Propolis was used by folk medicine for treatment of asthma but most of the studies were experimental. The objective of this study was to determine the effect of Propolis on clinical and physiological findings of moderate persistent asthma.<br /> Design: Prospective, randomized, double blind, placebo-controlled, clinical trial. <br /> Participants including major eligibility criteria: We enrolled patients aged 15-90 years with moderate asthma and FEV1 of 60-79% of predicted at a sub-specialty clinic of pulmonary medicine. We randomly allocated subjects to receive either Propolis (75 mg three times a day) or matched placebo for one month.<br /> Primary outcome was ACT (Asthma control test) score and secondary outcomes included dyspnea, Spirometry, FENO (Fractional Exhaled Nitric Oxide) and Sputum cytology including inflammatory cell. Sputum induction was made by hypertonic saline and cytology slides were stained by Papa Nicolaou stain.<br /> Results: Fifty two subjects were enrolled in this study and completed the course of therapy. Clinical findings including cough, dyspnea, wheezing, Sputum, post nasal drip, Nocturnal symptoms, Acute attack and wheezing were significantly improved after the treatment. ACT score was also significantly increased by Propolis (12.8±5.5 before and 18.1±4.99 after the trial) which was significantly higher than placebo (14.4±6.6 after the trial). The most significant physiological improvements were significant increase of FEV1, FEFV1/FVC, FEF25-75 and PEFR. FENO showed significant decrease in Propolis group, on the contrary it was increased in placebo group. Cytological examination of sputum showed that the pattern of inflammation was eosinophilic in 44% of subjects with average eosinophil of 7.2±1.01%. The eosinophilia was significantly decreased by Propolis after the trial (4.3±3.1%), but it was significantly increased in placebo group (11.1±6.6%).<br /> Conclusion: Propolis improved the clinical and physiological findings of moderate persistent of asthma, and it was also able to suppress the eosinophilic inflammation.<br />
public Majid Mirsadraee
No 80, 15th Kosar, Kosar Ave., Vakilabad Blv.
Mashhad Iran (Islamic Republic of) 91786 +98 51 1882 5505 majidmirsadraee@mshdiau.ac.ir Islamic Azad University- Mashhad Branch scientific Majid Mirsadraee MD
No 80, 15th Kosar, Kosar Ave., Vakilabad Blv.
Mashhad Iran (Islamic Republic of) 91786 +98 51 1882 5505 majidmirsadraee@mshdiau.ac.ir Islamic Azad University- Mashhad Branch Iran (Islamic Republic of) inclusion criteria: New subjects suffering from cough or dyspnea with an intermittent course and history of airway hyper responsiveness; controller drugs was not started; spirometry of the patients showing moderate asthma (forced expiratory volume in the first second between 60 to 80%). Exclusion criteria: mild (FEV1 mare than 80%); severe asthma (FEV1<60%); respiratory infection; treatment with systemic corticosteroid; rhinosinusitis; gastroesophageal reflux disease; other obstructive lung disease; Churg–Strauss syndrome; smokers; vocal cord dysfunction; reactive airway dysfunction syndrome. 7 years 90 years Both j459 asthma , unspecified Treatment - Drugs Placebo Moderate stage asthmatic subjects whom were not previously treated will be evaluated for clinical findings, spirometry, asthma control test, FENO, sputum cytology, IL-4 ، IFN-γ ، IL-17 and TLR-2 at the onset of the study. The subjects will be randomly divided in to two groups. Package of propolis and placebo will be produced in similar appearance and case group will recieve a pack ot Propolis which each pack contains 21 pills and each pill contains 125 mg. The package will get coded base on the random number table by a third person whom will be blind to groups. The code will be saved when the drug gives to the patient. The physician and pharmacist will blind to the codes. The subjects will follow during three weeks period of treatment by telephone call for assessing the side effects and exacerbation of symptoms. Emergency usage of Salbutamol inhaler will be permitted as needed. After 3 weeks the mentioned assessment will be repeated. Control group: Moderate stage asthmatic subjects who randomly allocated in control group will be evaluated for clinical findings, spirometry, asthma control test, FENO, sputum cytology, IL-4 ، IFN-γ ، IL-17 and TLR-2 as the same as trial group. Package of propolis and placebo will produce in similar appearance and in this group the pack contains 21 placebo pills. The package will get coded base on the random number table by a third person who will be blind to groups. The physician and pharmacist will keep blind to the codes. The subjects will follow during three weeks period of treatment by telephone call for assessing the side effects and exacerbation of symptoms. Emergency usage of Salbutamol inhaler will be permitted as needed. After 3 weeks the mentioned assessment will be repeated. Fractional exhaled Nitric Oxide (FENO). Timepoint: at the beginning of the study and at the end of the three weeks treatment. Method of measurement: expiratory nitric oxide test with NObreath equipment. ACT score test. Timepoint: At the beginning of the study and at the end of the three weeks treatment. Method of measurement: ACT questionnaire. Interleukin -4 (IL-4). Timepoint: At the begining and at the end of the three weeks of therapy. Method of measurement: ELIZA. Interleukin-17 (IL-17). Timepoint: At the begining and at the end of the three weeks of therapy. Method of measurement: ELIZA. Interferon-Y (INF-Y). Timepoint: At the begining and at the end of the three weeks of therapy. Method of measurement: ELIZA. Toll Like Receptor-2 (TLR-2). Timepoint: At the begining and at the end of the three weeks of therapy. Method of measurement: ELIZA. Dyspnea. Timepoint: At the beginning of the study and at the end of the three weeks treatment. Method of measurement: MMRC questionnaire. Forced expiratory volume in one second. Timepoint: at the beginning of the study and at the end of the three weeks treatment. Method of measurement: spirometry. Inflammatory cells of sputum. Timepoint: At the beginning of the study and at the end of the three weeks treatment. Method of measurement: sputum cytology. Cough. Timepoint: Before and after three weeks of trial time point. Method of measurement: Clinical assessment. Islamic Azad University of Mashhad Approved 2012-04-26 Ethical committee of Medical school Islamic Azad University- Mashhad branch Shahin Far Building , Azadi street , sarab alley mashhad Iran (Islamic Republic of)