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IRCT20210914052477N1 IRCT 2022-01-09 Mashhad University of Medical Sciences Evaluation the effects of camel milk on treatment of children with Cystic Fibrosis Evaluation the effects of camel milk in spirometry parameters in over 6 year’s children with Cystic Fibrosis lung disease 2021-12-22 anticipated 60 Complete https://irct.ir/trial/60180 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be assigned to either control or intervention groups according to a random number table provided by a computer (simple randomization). Allocation Concealment is done using sealed envelopes, Blinding description: Patients and patient outcome assessment will be unaware of Intervention and control groups. 3 Cystic Fibrosis lung disease in children. Intervention 1: Control group: Patients will receive airway clearance therapies( Hypertonic Saline, Inhaled shortacting beta-2 agonist, azithromycin) and 300 milliliter of cow milk per day as a placebo. Intervention 2: Intervention group: In addition to drug treatment, will receive 300 milliliter of pasteurized camel milk per day for two months. Yes - There is a plan to make this available What will be shared: All data can be shared after patients are made unidentifiable. When: Data can be accessible 6 months after results are published. To whom: Data will be available for researchers in universities and other scientific institutes. Conditions: Carrying out analysis on data is permitted. Where to obtain: Data can be accessible through sending an email to the corresponding author. How to obtain: After sending a request email to the corresponding author, data will be sent in 1 month. Comments:
public Dr Seyed Javad Sayedi
Akbar children Hospital, In front of Shahid Kave 14, Shahid Kaveh sq
Mashhad Iran (Islamic Republic of) 9139963185 +98 51 3870 9202 SayediJ@mums.ac.ir Mashhad University of Medical Sciences scientific Dr Seyed Javad Sayedi
Akbar children Hospital, In front of Shahid Kave 14, Shahid Kaveh sq
Mashhad Iran (Islamic Republic of) 9139963185 +98 51 3870 9202 SayediJ@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Over 6 year’s children with Cystic Fibrosis lung disease undergoing airway Clearance Treatment The patient is not in the acute exacerbation phase of the disease The patient has completed the Informed consent Form Those who have FEV1 more than 60% in spirometry 6 years no limit Both Those who are allergic to cow's milk Those who have a severe cough and sputum Those who are hospitalized Those who do not cooperate properly in spirometry E84 Cystic fibrosis Treatment - Drugs Treatment - Other Control group: Patients will receive airway clearance therapies( Hypertonic Saline, Inhaled shortacting beta-2 agonist, azithromycin) and 300 milliliter of cow milk per day as a placebo. Intervention group: In addition to drug treatment, will receive 300 milliliter of pasteurized camel milk per day for two months. Patients with Expiratory Volume in First Second (FEV1) greater than 60%. Timepoint: At the beginning of the study (before the intervention) and two months after beginning milk use (after the intervention). Method of measurement: spirometer device. Percentage of patient whose Forced Expiratory Volume in First Second (FEV1) increase 10%. Timepoint: At the beginning of the study (before the intervention) and two months after beginning milk use (after the intervention). Method of measurement: spirometer device. Mashhad University of Medical Sciences Approved 2021-08-15 Ethics Committee of Mashhad University of Medical Sciences Central Building of Mashhad University of Medical Sciences (Ghorshi),Daneshgah 16, Daneshgah Street Mashhad Razavi Khorasan Iran (Islamic Republic of)