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IRCT20151230025772N11 IRCT 2022-12-31 Zojaj Darman Toos Pharmaceutical company The preventive effect of short-term administration of a herbal combination of jujube and chamomile on the symptoms of intermittent mild asthma in children under 7 years old with viral cold. The preventive effect of short-term administration of a herbal combination of jujube and chamomile on the symptoms of intermittent mild asthma in children under 7 years old with viral cold. 2022-12-11 anticipated 50 Complete https://irct.ir/trial/67070 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization. Sealed envelopes are used to hide the treatment. Random numbers between 0 and 1 will be generated using the calculator. Envelopes that receive codes between 0 and 0.5 will be filled with placebo and envelopes that receive codes between 0.5 and 1 will be filled with medicine. In this way, the envelopes are arranged in a random order. The envelopes are thick and opaque. Patients and physicians do not know the content of the codes until the end of the study, Blinding description: In this study, double-blind sealed packages were used to hide the treatment from doctors and patients. The doctor and patients did not know the contents of the drug or placebo package. The drug and placebo are given to the patient in the same package. 2-3 asthma. Intervention 1: Intervention group: 25 children with mild intermittent asthma will be included in the study if they meet the inclusion criteria and do not have the exclusion criteria. In addition to their standard treatment, patients receive up to 2 weeks herbal drops containing chamomile and jujuba, prepared by a pharmacist and with an approved dose by a pediatric allergy and asthma specialist, at the rate of 0.5 cc per kilogram of the child's weight every 8 hours. Follow-up is done on the 3rd and 7th and 14th days by phone and according to the checklist .(The composition of the herbal drop,contains 10% of jujuba concentrate, 10% of chamomile concentrate and 80% water as solvent). Intervention 2: Control group: 25 children with mild intermittent asthma will be included in the study if they meet the inclusion criteria and do not have the exclusion criteria. In addition to their standard treatment, patients receive placebo drops for up to 2 weeks, which are completely similar to the examined drug and prepared by a pharmacist, with a dose approved by a pediatric allergy and asthma specialist, at the rate of 0.5 cc per a kilogram of the child's weight every 8 hours. Follow-up is done on the 3rd and 7th and 14th days by phone and according to the checklis .(the Placebo drop composition includes 10% starch syrup). No - There is not a plan to make this available Justification or reason for not sharing IPD is It is not yet known if there will be a plan to make this available.
public Dr.Hamid Ahanchian
Shahinfar Medical School , Emam Khomeini Ave.
Mashhad Iran (Islamic Republic of) 9187147578 +98 51 3225 0041 Ahanchianh@mums.ac.ir Islamic Azad University of medical science mashhad branch scientific Seyed Abbas Zojaji
Bo Ali Square, Mashhad University of Medical Sciences Technology Development Center
Mashhad Iran (Islamic Republic of) 9196773113 +98 51 3711 2611 info@zojaj.club Zojaj Darman Toos Pharmaceutical Company Iran (Islamic Republic of) children under 7 years old Confirmation of the diagnosis of mild intermittent asthma by a pediatric immunologist based on the GINA guidelines Having an acute respiratory viral infection no limit 7 years Both Bacterial respiratory infection Asthma exacerbation History of allergy to herbal medicines Congenital abnormalities Any underlying disease Lack of appropriate compliance for drug treatment Failure to refer for follow-up J44 Other chronic obstructive pulmonary disease Treatment - Drugs Placebo Intervention group: 25 children with mild intermittent asthma will be included in the study if they meet the inclusion criteria and do not have the exclusion criteria. In addition to their standard treatment, patients receive up to 2 weeks herbal drops containing chamomile and jujuba, prepared by a pharmacist and with an approved dose by a pediatric allergy and asthma specialist, at the rate of 0.5 cc per kilogram of the child's weight every 8 hours. Follow-up is done on the 3rd and 7th and 14th days by phone and according to the checklist .(The composition of the herbal drop,contains 10% of jujuba concentrate, 10% of chamomile concentrate and 80% water as solvent) Control group: 25 children with mild intermittent asthma will be included in the study if they meet the inclusion criteria and do not have the exclusion criteria. In addition to their standard treatment, patients receive placebo drops for up to 2 weeks, which are completely similar to the examined drug and prepared by a pharmacist, with a dose approved by a pediatric allergy and asthma specialist, at the rate of 0.5 cc per a kilogram of the child's weight every 8 hours. Follow-up is done on the 3rd and 7th and 14th days by phone and according to the checklis .(the Placebo drop composition includes 10% starch syrup) Cough. Timepoint: first visit , the third day, the seventh day, the fourteenth day. Method of measurement: Number of coughs per day/cough severity based on visual analog scale. Nighttime wakeup due to coughing. Timepoint: first visit , the third day, the seventh day, the fourteenth day. Method of measurement: amount. The amount of salbutamol usage. Timepoint: first visit , the third day, the seventh day, the fourteenth day. Method of measurement: number of puff per day. Oral corticosteroid need. Timepoint: first visit , the third day, the seventh day, the fourteenth day. Method of measurement: has/doesn't have. Specialist visit requierment. Timepoint: the third day, the seventh day, the fourteenth day. Method of measurement: has/doesn't have. Need for hospital admission. Timepoint: the third day, the seventh day, the fourteenth day. Method of measurement: has/doesn't have. Zojaj Darman Toos Pharmaceutical company Approved 2022-07-27 Ethics Committee of islamic Azad university -Mashhad Branch Shahinfar Medical School . Imam khomeini ave. Mashhad Razavi Khorasan Iran (Islamic Republic of)