Determining the effect of flaxseed syrup on the clinical symptoms of asthma in children 5 to 17 years old referred to the pulmonary clinic of Mofid Children's Hospital in 1400
Design
Clinical trial, with control group, non-blind, randomized, phase 3, on 80 patients
Randomized with a table of random numbers and 4 blocks
Settings and conduct
This study will be done at pulmonary clinic of Mofid's children hospital. Patients enrolled in the study are divided into intervention and control groups, and both groups receive classic asthma (fluticasone spray 125 micrograms 1 puff every 12 hours and salbutamol spray in case of exacerbation of symptoms). The intervention group also receives flaxseed syrup.
At the beginning and end of the study (end of week 8) all patients will be evaluated by taking complete history, doing clinical examination and filling questionnaires (CACT (Children Asthma Control Test) for children under 12 years and ACT (Asthma Control Test) for children 12-17 years) . Finally the results of the two groups are compared.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age between 5-17 years, with mild to moderate persistent asthma, willingness to participate in the study
Non-inclusion criteria: ages less than 5 or more than 17 years, suffering from a variety of underlying respiratory diseases
Intervention groups
Both groups will receive classic asthma medication. The intervention group will also receive flaxseed syrup in addition to this treatment
Main outcome variables
Asthma control facilitation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210801052048N1
Registration date:2021-09-27, 1400/07/05
Registration timing:prospective
Last update:2021-09-27, 1400/07/05
Update count:0
Registration date
2021-09-27, 1400/07/05
Registrant information
Name
Soroush Samari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7746 7432
Email address
soroush.samari@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-02, 1400/07/10
Expected recruitment end date
2022-03-21, 1401/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Flaxseed Syrup on clinical manifestation of the pediatric asthma
Public title
The effect of Flaxseed Syrup on clinical manifestation of the pediatric asthma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Asthmatic patients between 5-17 years old referring to respiratory diseases clinic at Mofid children hospital, Tehran in 1400
Exclusion criteria:
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
Age
From 5 years old to 17 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
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
2
Description
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
3
Description
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
Secondary outcomes
empty
Intervention groups
1
Description
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).
Category
Treatment - Drugs
2
Description
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)