]>
IRCT20210801052048N1 IRCT 2021-09-27 Shahid Beheshti University of Medical Sciences The effect of Flaxseed Syrup on clinical manifestation of the pediatric asthma The effect of Flaxseed Syrup on clinical manifestation of the pediatric asthma 2021-10-02 anticipated 80 Complete https://irct.ir/trial/57898 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: block Randomization unit: individual Randomization tool: Randomization number table Sequence making method: In a table of random numbers, a number is randomly selected from the table and the next numbers are selected in a row or column in the up, down, left or right direction. Because the number of modes of 4 blocks for two groups is 6 modes, numbers higher than 6 and zero are ignored in the table and each digit specifies the desired block. 3 Condition 1: Mild persistent asthma, uncomplicated. Condition 2: Moderate persistent asthma, uncomplicated. Intervention 1: Intervention group: Flaxseed syrup is prepared by boiling flaxseed in water and then adding honey until it reaches a suitable consistency and taste. Microbial preservatives are added and physical and chemical quality control tests are performed on the product. This syrup with a daily dose of 5-10 cc (5 cc for children weighing less than 30 kg and 10 cc for weights over 30 kg) in three servings (0.8 mg in 5 cc syrup) for group members Intervention is prescribed. All of these people will also be treated for mild to moderate persistent asthma (with fluticasone and salbutamol sprays). Intervention 2: Control group: These people will only receive the classic treatment for mild to moderate persistent asthma. (Fluticasone spray 125 micrograms 1 puff every 12 hours and salbutamol spray in case of acute exacerbation of symptoms). 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 There is no more information
public Soroush Samari Kermani
Unit 2, No. 7, Kermanshahi Alley, Mostaeddi St., Abdolazimi St, Imamat
Tehran Iran (Islamic Republic of) 1741873581 +98 21 7746 7432 soroush.samari@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Soroush Samari Kermani
Unit 2, No. 7, Kermanshahi Alley, Mostaeddi St., Abdolazimi St, Imamat
Tehran Iran (Islamic Republic of) 1741873581 +98 21 7746 7432 soroush.samari@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Asthmatic patients between 5-17 years old referring to respiratory diseases clinic at Mofid children hospital, Tehran in 1400 5 years 17 years Both unwillingness to participate in the study Suffering from severe asthma requiring hospitalization Suffering from other disease such as CF, BPD, heart failure, Tracheobronchomalacia, GERD, bronchiectasis, PTE and sarcoidosis Using ASA, beta blockers or NSAIDs Sensitivity to flaxseed and honey syrup components Suffering from acute asthma attack J45.30 J45.40 Mild persistent asthma, uncomplicated Moderate persistent asthma, uncomplicated Treatment - Drugs Treatment - Drugs Intervention group: Flaxseed syrup is prepared by boiling flaxseed in water and then adding honey until it reaches a suitable consistency and taste. Microbial preservatives are added and physical and chemical quality control tests are performed on the product. This syrup with a daily dose of 5-10 cc (5 cc for children weighing less than 30 kg and 10 cc for weights over 30 kg) in three servings (0.8 mg in 5 cc syrup) for group members Intervention is prescribed. All of these people will also be treated for mild to moderate persistent asthma (with fluticasone and salbutamol sprays). Control group: These people will only receive the classic treatment for mild to moderate persistent asthma. (Fluticasone spray 125 micrograms 1 puff every 12 hours and salbutamol spray in case of acute exacerbation of symptoms) Dyspnea based on ACT and CACT questionnaires, history and physical examination. Timepoint: Filling in ACT and CACT questionnaires at the beginning of the study and at the end of week 8, history and examination at the beginning of the study and at the end of weeks 4 and 8, telephone history at the end of weeks 2 and 6. Method of measurement: ACT and CACT questionnaires (Asthma Control Test & Children Asthma Control Test), visit of a pediatric specialist in respiratory diseases. Wheezing based on ACT and CACT questionnaire and history or hearing examination. Timepoint: Filling in ACT and CACT questionnaires at the beginning of the study and at the end of week 8, history and examination at the beginning of the study and at the end of weeks 4 and 8, telephone history at the end of weeks 2 and 6. Method of measurement: ACT and CACT questionnaires (Asthma Control Test & Children Asthma Control Test), visit of a pediatric specialist in respiratory diseases. Cough based on ACT and CACT questionnaires, history and physical examination. Timepoint: Filling in ACT and CACT questionnaires at the beginning of the study and at the end of week 8, history and examination at the beginning of the study and at the end of weeks 4 and 8, telephone history at the end of weeks 2 and 6. Method of measurement: ACT and CACT questionnaires (Asthma Control Test & Children Asthma Control Test), visit of a pediatric specialist in respiratory diseases. Shahid Beheshti University of Medical Sciences Approved 2021-08-31 Ethics committee of Shahid Beheshti University of Medical Sciences 7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak Tehran Tehran Iran (Islamic Republic of)