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IRCT20180527039867N1 IRCT 2018-06-13 Iran University of Medical Sciences Evaluation the effect of syrup made from sweet Almond in pediatric nocturnal cough Evaluation of the effectiveness of a syrup made from sweet Almond in pediatric nocturnal cough with upper respiratory tract infection(common cold) compared to Diphenhydramine: A randomized clinical trial 2018-08-23 anticipated 60 Complete https://irct.ir/trial/31586 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization based on random numbers. 3 Cough due to upper respiratory tract infection(common cold). Intervention 1: Intervention group: The oral syrup from sweet almond (equivalent to the dose of Diphenhydramine syrup received in the control group: 1 mg/ kg ) will be prescribed in 1 Dose half an hour before bedtime.Duration of treatment is 2 nights. Intervention 2: Control group: Diphenhydramine syrup (Al Havi®) will be prescribed 1 mg/kg/day in 1 Dose half an hour before bedtime.Duration of treatment is 2 nights. 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 No more information
public Zahra Karimi
No. 847 , Vahdat-e-Islami St , South side of Park City , Hassan Abad Square, Behesht Street, Faculty of Iranian Medicine
Tehran Iran (Islamic Republic of) 114733311 +98 21 5558 0388 karimi.z@tak.iums.ac.ir Iran University of Medical Sciences scientific Omid Sadeghpour
Faculty of Iranian Medicine, 847,Behesht Street,South side of Park City,Vahdat-e-Islami St.,, Hassan Abad Square,tehran
Tehran Iran (Islamic Republic of) 1114733311 +98 21 5558 0388 o.sadegh33@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) The patients's age is two to twelve years old Cough due to upper respiratory tract infection (common cold) for less than 7 days Concomitant symptoms (mild fever: less than 39 ° C, sore throat, cramps, rhinorrhea, mild headache, feeling tired, sneezing Do not use any anti-cough product 18 hours before the intervention Lack of underlying disease (asthma, allergic rhinitis, sinusitis, laryngo tracheobronchitis, congenital heart disease, chronic lung disease, diabetes, kidney disease) Conscious written consciously from parents to enter the study Possibility of patient Follow up 2 years 12 years Both Children with signs and symptoms of asthma, pneumonia, allergic rhinitis, sinusitis, laryngo tracheobronchitis, congenital heart disease, chronic lung disease, diabetes, kidney disease The onset of symptoms of otitis, sinusitis, onset of symptoms of of the lower respiratory tract infection , the addition of a bacterial infection to the viral infection (edema, respiratory problem, severe sore throat with painful ingestion, nausea, vomiting, fever above 39 °, septic nasal discharge, Facial and peri orbital pain) during the intervention Lack of allergy (presence of symptoms such as i itchy eye & nose, a history of prolonged cold periods,history of repeating similar symptoms, positive family history of allergy, history of drug and food allergy), The presence of sign and symptoms of a Reactive Airway Disease including: tachypnea and tachycardia, short breath, chest tightness ) Getting any anti cough drug before intervention Not using or using irregularly recommended medications Add other cough drugs to treatment during the intervention allergic reaction to drug combinations during the study disrelish to cooperate until the end of the study Inaccessibility of the patient during the study J06 Acute nasopharyngitis [common cold] Treatment - Drugs Treatment - Drugs Intervention group: The oral syrup from sweet almond (equivalent to the dose of Diphenhydramine syrup received in the control group: 1 mg/ kg ) will be prescribed in 1 Dose half an hour before bedtime.Duration of treatment is 2 nights Control group: Diphenhydramine syrup (Al Havi®) will be prescribed 1 mg/kg/day in 1 Dose half an hour before bedtime.Duration of treatment is 2 nights. Cough frequency. Timepoint: At the beginning of the study, the first and second day of intervention. Method of measurement: Likert scale Checklist. Cough severity. Timepoint: At the beginning of the study, the first and second day of intervention. Method of measurement: Likert scale Checklist. Nightly sleep quality of the child. Timepoint: At the beginning of the study, the first and second day of intervention. Method of measurement: Likert scale Checklist. Nightly sleep quality of the parent. Timepoint: At the beginning of the study, the first and second day of intervention. Method of measurement: Likert scale Checklist. Time Control Signs. Timepoint: Any time during the study. Method of measurement: Report by the child's parents. Iran University of Medical Sciences Approved 2018-05-30 Ethics committee of Iran University of Medical Sciences Fifth Floor, Headquarters, Hemet Highway Between Chamran and Sheikh Fazlullah, Iran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)