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IRCT201107312695N2 IRCT 2013-05-13 Vice chancellor for research, Islamic Azad University- Mashhad Branch Benefit of platanus and Rosemary extract on treatment of resistant asthma Benefit of Oral Platanus and Rosemary extract on clinical, physiological and biological improvement of resistant asthma, a double blind randomized placebo controlled active comparator study on asthmatic resistant to traditional treatment. 2013-03-06 anticipated 30 Complete https://irct.ir/trial/2495 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Treatment, Other design features: All recruited asthmatic subjects will randomly divided to two groups of herbal extract by computer generated randomization list. Both groups contain one true herbal drug (Rosemary or Platanus) and one placebo. The physician and pharmacist are blind to the exact herbal drug which the subject will be started with (Rosemary or Platanus). The Platanus, Rosemary and their placebos were in bottle form and identical in appearance. They were prepacked in bottles and consecutively numbered for each patient according to the randomization schedule which is not introduced to the physician and pharmacist. 2 Asthma. Intervention 1: Starting the trial: As mentioned above all symptomatic asthmatic subjects whom were resistant to treatment with inhaled corticosteroids, Salmetrol, Montelukast and theophilline will be entered in this study. The subjects will continue their previous drugs after that they will be randomly divided in two groups to consume two new herbal drugs. One group will receive platanus extract and placebo in addition to previous drugs and second group will receive Rosemary extract and placebo. Rosemary and Platanus extract has produced by Birjand herbal company and served as liquid which will be drunk (50 CC three times a day). After one month the outcome variables will be evaluated. Evaluations consist of clinical evaluation as like as symptoms (cough and dyspnea) and sign (wheeze) and clinical improvement of asthma by validated ACT (Asthma control test) questionnaire; and paraclinical tests such as spirometry (Superspiro, Micromedical instruments, England) and FENO (No Breath, Bedfont Medical instruments, England). Subjects whom showed complete improving or side effects of extract will be exited from study. Then both groups will receive placebo with similar shape to previous drugs for one month in order to wash out previous drugs. Intervention 2: Second phase: Subjects will be evaluated for primary outcomes. Evaluations consist of clinical evaluation as like as symptoms (cough and dyspnea) and sign (wheeze) and clinical improvement of asthma by validated ACT (Asthma control test) questionnaire; and paraclinical tests such as spirometry (Superspiro, Micromedical instruments, England) and FENO (No Breath, Bedfont Medical instruments, England). Subjects whom showed complete improving or side effects of extract will be exited from study. At the third month the groups will be changed and they will use other extract. At the beginning of fourth month primary outcomes will be evaluated as mentioned above and then both groups will receive placebo again for wash out. Intervention 3: Third (last) phase: In the last month (fifth month) both groups will receive both extracts and trial will be finished with evaluation of outcome parameters for last time. Outcome parameters will be evaluated before and after of this phase. Evaluations consist of clinical evaluation as like as symptoms (cough and dyspnea) and sign (wheeze) and clinical improvement of asthma by validated ACT (Asthma control test) questionnaire; and paraclinical tests such as spirometry (Superspiro, Micromedical instruments, England) and FENO (No Breath, Bedfont Medical instruments, England).
public Majid Mirsadraee
No 80, 15th Kosar, Kosar Ave., Vakilabad Blv.
Mashhad Iran (Islamic Republic of) 9178673799 +98 51 1882 5505 majidmirsadraee@mshdiau.ac.irmajidmirsadraee@yahoo.com 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, majidmirsadraee@yahoo.com Islamic Azad University- Mashhad Branch Iran (Islamic Republic of) Inclusion criteria: 1- Resistant asthma to Inhaled corticosteroid, long acting beta 2 agonist, antileukotrien and theophyllin Exclusion criteria: 1- Respiratory infection 2- Fair Treatment with controller drugs 3- Not cooperative with project 4- congestive heart failure 5- Gastroesophageal reflux 6- Rhinosinusitis, 7- pregnancy 8- smoking 9- non asthmatic other lung disease and non pulmonary disease 12 years 91 years Both J459 Asthma, unspecified Treatment - Drugs Treatment - Drugs Treatment - Drugs Starting the trial: As mentioned above all symptomatic asthmatic subjects whom were resistant to treatment with inhaled corticosteroids, Salmetrol, Montelukast and theophilline will be entered in this study. The subjects will continue their previous drugs after that they will be randomly divided in two groups to consume two new herbal drugs. One group will receive platanus extract and placebo in addition to previous drugs and second group will receive Rosemary extract and placebo. Rosemary and Platanus extract has produced by Birjand herbal company and served as liquid which will be drunk (50 CC three times a day). After one month the outcome variables will be evaluated. Evaluations consist of clinical evaluation as like as symptoms (cough and dyspnea) and sign (wheeze) and clinical improvement of asthma by validated ACT (Asthma control test) questionnaire; and paraclinical tests such as spirometry (Superspiro, Micromedical instruments, England) and FENO (No Breath, Bedfont Medical instruments, England). Subjects whom showed complete improving or side effects of extract will be exited from study. Then both groups will receive placebo with similar shape to previous drugs for one month in order to wash out previous drugs. Second phase: Subjects will be evaluated for primary outcomes. Evaluations consist of clinical evaluation as like as symptoms (cough and dyspnea) and sign (wheeze) and clinical improvement of asthma by validated ACT (Asthma control test) questionnaire; and paraclinical tests such as spirometry (Superspiro, Micromedical instruments, England) and FENO (No Breath, Bedfont Medical instruments, England). Subjects whom showed complete improving or side effects of extract will be exited from study. At the third month the groups will be changed and they will use other extract. At the beginning of fourth month primary outcomes will be evaluated as mentioned above and then both groups will receive placebo again for wash out. Third (last) phase: In the last month (fifth month) both groups will receive both extracts and trial will be finished with evaluation of outcome parameters for last time. Outcome parameters will be evaluated before and after of this phase. Evaluations consist of clinical evaluation as like as symptoms (cough and dyspnea) and sign (wheeze) and clinical improvement of asthma by validated ACT (Asthma control test) questionnaire; and paraclinical tests such as spirometry (Superspiro, Micromedical instruments, England) and FENO (No Breath, Bedfont Medical instruments, England). FEV1. Timepoint: before treatment and one month after treatment. Method of measurement: spirometry superspiro, Micromedical company, England. Exhaled Nitric oxide (FENO). Timepoint: before treatment and one month after treatment. Method of measurement: Chemiluminescence instrument, No Breath, Bedfont company, England. ACT Questionnaire. Timepoint: before treatment and one month after treatment. Method of measurement: Validated Asthma control test Questionnaire. IL-17. Timepoint: Before treatment and One month after treatment. Method of measurement: ELIZA- Qiagen company Tehran Iran. INF- Gamma. Timepoint: Before treatment and One month after treatment. Method of measurement: ELIZA- Qiagen company Tehran Iran. Vice chancellor for research, Islamic Azad University- Mashhad Branch Approved 2011-04-08 Ethical committee of Medical school Islamic Azad University- Mashhad branch Shahin Far Building- Sarab Street- Azadi street Mashhad Iran (Islamic Republic of)