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IRCT20191221045837N3 IRCT 2020-10-24 Mashhad University of Medical Sciences Effect of Nanomicelle Curcumin in pediatric asthma Evaluation of the Effectiveness of Nanomicelle Curcumin Formulation on Clinical and Spirometry Parameters of Asthma in Children 2020-11-05 anticipated 90 Complete https://irct.ir/trial/51161 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: Block randomization Randomization tool: https://www.sealedenvelope.com/ How to make a random sequence: To perform this method, the number of intervention groups (two groups A and B), the volume of each block (6 in each block) and the number of sample size (90 patients) were entered into the website. The site then provided a list of 15 blocks, each contains 6 patients. In this study, we use 6 patients in each block and the website randomizes and numbers the blocks. Allocation Concealment Method: Sealed Envelopes, Blinding description: The study is double-blinded in which the patients, evaluators, analysts, sample allocators will be unaware of the intervention and control groups. The medication and placebo will be produced in the same dosage form and packaging by the manufacturer and will be numbered according to a random list. Physicians, patients, and analyst will remain unaware of the type of drug or placebo formulation until the work is completed. At the beginning of the study, the patient will be explained that he or she may be in the medication or placebo group. 2-3 asthma. Intervention 1: Intervention group: In the intervention group, asthmatic patients will receive standard treatment of asthma (based on asthma severity and according to the Global Initiative for Asthma (GINA) 2019 Guidelines) along with curcumin syrup at a dose of 40 mg (1 ml) orally daily for two months. In this study, Sina curcumin product in syrup formulation (made by Exir Nano Sina Company) will be used. Medication and placebo are provided by the company. Curcumin syrup is prepared at a concentration of 40 mg/ml. Intervention 2: Control group: In the control group, asthmatic patients will receive standard treatment of asthma (based on asthma severity and according to the Global Initiative for Asthma (GINA) 2019 Guidelines) along with the volume equivalent of placebo syrup (1 ml) orally daily for two months. Medication and placebo are provided by the Exir Nano Sina company. Yes - There is a plan to make this available What will be shared: After the end of the study, data collection and data transfer to SPSS software, data can be shared. When: Access period starts 6 months after the results are published To whom: Researchers working in academic, scientific and industrial institutes Conditions: No one is allowed to use the documents except the principal investigator. Where to obtain: Send an email to Dr. Zeinat Heydari. heidarizn@mums.ac.ir How to obtain: Send an email to Dr. Zeinat Heydari. heidarizn@mums.ac.ir Comments:
public Zinat Heidari
Faculty of Pharmacy, University Campus, Azadi Square, Mashhad, Khorasan Razavi.
Mashhad Iran (Islamic Republic of) 9177948954 +98 51 3180 1584 heidarizn@mums.ac.ir Mashhad University of Medical Sciences scientific Zinat Heidari
Faculty of Pharmacy, University Campus, Azadi Square, Mashhad, Khorasan Razavi.
Mashhad Iran (Islamic Republic of) 9177948954 +98 51 3180 1584 heidarizn@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Pediatric patients admitted to allergy subspecialized clinic of Akbar hospital 6-12 years old With mild persistant asthma based on Global Initiative for Asthma (GINA) 2019 guideline Informed consent of patient/caregiver 6 years 12 years Both Patients with pulmunary infection Patients with underlying cardiac, hepatic, biliary, renal, or gastrointestinal diseases or allergic rhinitis Patients with smoker parents Patients taking anticoagolant or antiplatelet medications Patients with diabetes J45.3 Mild persistent asthma Treatment - Drugs Placebo Intervention group: In the intervention group, asthmatic patients will receive standard treatment of asthma (based on asthma severity and according to the Global Initiative for Asthma (GINA) 2019 Guidelines) along with curcumin syrup at a dose of 40 mg (1 ml) orally daily for two months. In this study, Sina curcumin product in syrup formulation (made by Exir Nano Sina Company) will be used. Medication and placebo are provided by the company. Curcumin syrup is prepared at a concentration of 40 mg/ml. Control group: In the control group, asthmatic patients will receive standard treatment of asthma (based on asthma severity and according to the Global Initiative for Asthma (GINA) 2019 Guidelines) along with the volume equivalent of placebo syrup (1 ml) orally daily for two months. Medication and placebo are provided by the Exir Nano Sina company. Patients' clinical signs score in asthma control questionnaire (c-ACT). Timepoint: At baseline and end of the study (end of the second month). Method of measurement: Asthma Control Questionnaire. Maximal Mid-Expiratory Flow rate (MMEF25-75). Timepoint: At baseline and end of the study (end of the second month). Method of measurement: spirometry test. Value of Forced expiratory volume in one second (FEV1). Timepoint: At baseline and end of the study (end of the second month). Method of measurement: spirometry test. Value of Forced Vital Capacity (FVC). Timepoint: At baseline and end of the study (end of the second month). Method of measurement: spirometry test. Ratio of Forced expiratory volume in one second (FEV1)/Value of Forced Vital Capacity (FVC). Timepoint: At baseline and end of the study (end of the second month). Method of measurement: spirometry test. Mashhad University of Medical Sciences Approved 2019-12-07 Ethics committee of Mashhad University of Medical Sciences Central department of Mashhad University of Medical Sciences, next to Alton Tower, Daneshgah Street, Mashhad, Khorasan Razavi Province Mashhad Razavi Khorasan Iran (Islamic Republic of)