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IRCT20161226031584N2 IRCT 2019-06-17 Mashhad University of Medical Sciences Investigation of effect of Oral Nanomicelle Curcumin in Patients with Non-atopic Bronchial Asthma Investigation of effect of oral nanomicell curcumin on Improving of FEV1 and Quality of Life in Patients with Non-atopic Bronchial Asthma 2017-08-23 anticipated 60 Complete https://irct.ir/trial/24812 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: nanomicell curcumin, Randomization description: Simple randomization, randomization method :( Random Concealmen), Blinding description: A random allocation was made after explaining how to conduct the research and obtaining informed consent from patients. The type of treatment prescribed for each patient (in the form of Paired and odd numbers or code A, B) was written in tabs and each sheet was placed in an envelope. After the patient's visit, if the patient has inclusion critria, then he will remove the random concealment after explaining how the doctor will study. The checklist for demographic information and questionnaires used in the project is completed with the help of the researcher. The assigned number (Paired and odd numbers) is given to the patient (the blind doctor) and how they are used. The researcher records the delivered drug code (Paired and odd numbers). Due to the fact that the placebo is in every way similar to intervention, patients will not be aware of which group they are (patients are blind). After collecting the data, the analyzer analyzes the data according to their code (paired or individual).They (the evaluator and analyzer) will not be aware of the treatment. 3 Asthma. Intervention 1: Interventional group:Oral curcumin 40 mg three times a day (Sinacurcumin nanomicelle, Minoo Pharmacy Company, Tehran, Iran) as an Add-on therapy in Patients of Bronchial Asthma that the patient received in the past. Intervention 2: Control group: The placebo(which appears to be completely similar to the drug)was given three times daily as an Add-on therapy in Patients of Bronchial Asthma that the patient received in the past. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Data analysis has not yet been performed
public Shahrzad Mohamadzadeh Lari
Pulmonary Disease Research Center, Ghaem Hospital
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3859 4083 larish@mums.ac.ir Mashhad University of Medical Sciences scientific Shahrzad Mohamadzadeh Lar
Ahmadabad Ave, Ghaem Hosital
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3859 4083 larish@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) non atoic asthma informed consent 18 years no limit Both smoker COPD pregnancy/lactation heart ,liver,kidney disorder and gallbladder disease acute exacerbation within one month ago J40-J47 Chronic lower respiratory diseases Treatment - Drugs Placebo Interventional group:Oral curcumin 40 mg three times a day (Sinacurcumin nanomicelle, Minoo Pharmacy Company, Tehran, Iran) as an Add-on therapy in Patients of Bronchial Asthma that the patient received in the past. Control group: The placebo(which appears to be completely similar to the drug)was given three times daily as an Add-on therapy in Patients of Bronchial Asthma that the patient received in the past FEV1,ACT ,AQLQ. Timepoint: Measuring the FEV1-ACT, AQLQ questionnaire every two weeks to two months. Method of measurement: questionnaire ,spirometry,physical exam. Pulmonary Diseases Research Center Approved 2016-06-23 The code of ethics is "IR.MUMS.fm.REC.1395.259" and the date of approval is 03/04/1395. Ahmadabad steet Mashhad Razavi Khorasan Iran (Islamic Republic of)