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Trial Status
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Before
on_going
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completed
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Abstract
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Before
Abstract
Introduction: Asthma is the most common chronic pulmonary disease in children. Despite improvement in control and treatment of it, its prevalence within children is increasing in the world, especially in developing countries.¬ Cough is a most prevalent and disturbing symptom in these children. This study aims for investigating the effect of violet syrup on cough alleviation and suppression in children with intermittent asthma.
Materials and Methods: ¬ this case-control clinical trial was conducted on children (2-12 years old) with intermittent asthma, visiting outpatient clinics in Qom from August 23, 2013 to February 20, 2014.¬ Children were divided into two equal groups, namely case and control, each with 91 subjects. The control group undertook intermittent asthma treatment (using salbutamol inhaler). The case group received violet syrup for 5 days, in addition to standard treatment. Both control and case groups were asked about the duration of cough reduction and suppression.
Findings: ¬ in total, among 182 participants 107 subjects (58.8%) were boy and 75 subjects (41.2%) were girl. Frequency distribution of samples in both control and case groups was not statistically significant in terms of sex (p=0.292).¬ Children were 3.24±2.05 years old, on average, which was not significantly different in both groups (p=0.914). Frequency distribution of cough reduction and suppression in both groups was not statistically significant in terms of sex (p=0.337, and p=0.337, respectively). In addition, the rate of cough suppression in both control and case groups was not significantly different (p<0.001).
Discussion and Conclusion: ¬ this study showed that violet syrup is markedly more effective than placebo in reduction and suppression of intermittent asthma induced cough in children between 2 and 12 years old. Therefore, with respect to relative low cost and good therapeutic response to it, using this syrup is recommended in treatment of children with cough.
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After
This study is designed to evaluate violet flower syrup efficacy as add-on treatment in alleviation of cough in pediatric patients with intermittent asthma in a randomized double blind placebo-controlled clinical trial design. This study includes 182 children from out patient pediatric asthma clinic in Qom, Iran. Children between 2-12 years old with the clinical diagnosis of intermittent asthma are considered for inclusion in the study. Children who need or take treatments other than short acting beta agonists, having smoker family member, suffering from other chronic diseases will be excluded from the study. After taking the Informed consent from the parents the patients will be randomized to receive violet syrup with sulbutamol spray or placebo syrup with sulbutamol spray for 5 days. The patients will be evaluated regarding the duration lasted for the 50% cough alleviation and cough stop after 5 days. The numbers of patients achieve the cough alleviation and suppression before 3 days and 5 days will be compared between two groups.
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Last Published
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Before
December 12, 2014 09:42 AM
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After
February 16, 2015 03:31 PM
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Intervention (Public)
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Before
This case-control clinical trial was conducted on children (2-12 years old) with intermittent asthma, visiting outpatient clinics in Qom from August 23, 2013 to February 20, 2014.¬ Children were divided into two equal groups, namely case and control, each with 91 subjects. The control group was received standard treatment of intermittent asthma (using salbutamol inhaler). The case group received violet syrup (Kimiagar Tous Pharmaceutical Co) for 5 days (2.5cc three times per day, and 5cc three times per day were administered to 2-5 and over 5 years old children, respectively), in addition to standard treatment. Both control and case groups were asked about the duration of reduction and suppression of cough. Inclusion criteria were having intermittent asthma infection and receiving salbutamol standard treatment. In case of taking other interfering drugs for treating asthma, consuming inhaled and oral corticosteroids, having smoker family member, and suffering from other diseases, the subject was removed from the study.¬¬¬ For the purpose of the study, convenience sampling method was used, taking inclusion and exclusion criteria into consideration. For data collection, questionnaire and interview were employed.¬¬ Demographic information of the patients included age, sex, place of living address, educational level of parents, cough reduction rate, cough alleviation rate, and duration of cough suppression in both groups was recorded.
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After
Active group: Salbutamol spray (2 puff- 216 mcg Q6h) + Violet syrup (2.5cc or 5cc three times per day for 2-5 and over 5 years old children, respectively)
Placebo group: Salbutamol spray (2 puff- 216 mcg Q6h) + Placebo syrup (2.5cc or 5cc three times per day for 2-5 and over 5 years old children, respectively)
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Primary Outcomes (End Points)
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Before
This study showed that violet syrup is markedly more effective than placebo in reduction and suppression of intermittent asthma caused cough in children between 2 and 12 years old. Therefore, with respect to relative low cost of it and good therapeutic response to it, using this syrup is recommended in treatment of children with cough.
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After
Number of patients achieved 100% cough suppression in 1-3 days in each group, based on parental report
Number of patients achieved 100% cough suppression in 3-5 days in each group, based on parental report
Number of patients not achieved 100% cough suppression in 5 days in each group, based on parental report
Number of patients achieved 50% cough alleviation in 1-3 days in each group, based on parental report
Number of patients achieved 50% cough alleviation in 3-5 days in each group, based on parental report
Number of patients not achieved 50% cough alleviation in 5 days in each group, based on parental report
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Experimental Design (Public)
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Before
¬ this case-control clinical trial was conducted on children (2-12 years old) with intermittent asthma, visiting outpatient clinics in Qom from August 23, 2013 to February 20, 2014.¬ Children were divided into two equal groups, namely case and control, each with 91 subjects. The control group undertook intermittent asthma treatment (using salbutamol inhaler). The case group received violet syrup for 5 days, in addition to standard treatment. Both control and case groups were asked about the duration of cough reduction and suppression
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After
The study will be done as Double-Blind Randomized Controlled Clinical Trial. The participants (182 children) will be randomly assigned, following block randomization with 1:1 allocation ration. Participants, their parents and those assessing the outcomes will be blinded to group assignment.
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Randomization Method
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Before
the children’s parents completed and signed the informed written consent forms for conducting the study and the relevant experiments before entering the study. The participants were randomly assigned, following simple randomization procedures (1 : 1), to receive Viola flower syrup or
placebo along with the common protocol. Participants and their parents and those assessing the outcomes were blinded to group assignment.
Patient assigned to placebo received the same solution as Viola flower syrup but without Viola flower.
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After
Block randomization, Generalized by Excel
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Randomization Unit
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Before
the children’s parents completed and signed the informed written consent forms for conducting the study and the relevant experiments before entering the study. The participants were randomly assigned, following simple randomization procedures (1 : 1), to receive Viola flower syrup or
placebo along with the common protocol. Participants and their parents and those assessing the outcomes were blinded to group assignment.
Patient assigned to placebo received the same solution as Viola flower syrup but without Viola flower.
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After
No clustered or more than one level randomization
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Planned Number of Observations
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Before
iam sure
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180 patient
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Sample size (or number of clusters) by treatment arms
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Before
91 patient in intervention group and 91 patient in control group.
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After
90 patient in intervention group and 90 patient in control group.
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