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The Effect of Viola flower Syrup on Cough of Children with Asthma: A Double-Blind Randomized Controlled Trial
Last registered on February 16, 2015

Pre-Trial

Trial Information
General Information
Title
The Effect of Viola flower Syrup on Cough of Children with Asthma: A Double-Blind Randomized Controlled Trial
RCT ID
AEARCTR-0000580
Initial registration date
December 12, 2014
Last updated
February 16, 2015 3:31 PM EST
Location(s)
Primary Investigator
Affiliation
Islamic Azad University
Other Primary Investigator(s)
PI Affiliation
Department of Medicine, Qom Branch, Islamic Azad University, Qom, Iran
Additional Trial Information
Status
Completed
Start date
2014-10-01
End date
2014-12-17
Secondary IDs
Abstract
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.
External Link(s)
Registration Citation
Citation
Gharehbeglou, Mohammad and Mohammad Qasemzadeh. 2015. "The Effect of Viola flower Syrup on Cough of Children with Asthma: A Double-Blind Randomized Controlled Trial." AEA RCT Registry. February 16. https://doi.org/10.1257/rct.580-2.0.
Former Citation
Gharehbeglou, Mohammad and Mohammad Qasemzadeh. 2015. "The Effect of Viola flower Syrup on Cough of Children with Asthma: A Double-Blind Randomized Controlled Trial." AEA RCT Registry. February 16. https://www.socialscienceregistry.org/trials/580/history/3612.
Experimental Details
Interventions
Intervention(s)
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)

Intervention Start Date
2014-10-01
Intervention End Date
2014-12-15
Primary Outcomes
Primary Outcomes (end points)
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


Primary Outcomes (explanation)
Secondary Outcomes
Secondary Outcomes (end points)
Secondary Outcomes (explanation)
Experimental Design
Experimental Design
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.
Experimental Design Details
Randomization Method
Block randomization, Generalized by Excel
Randomization Unit
No clustered or more than one level randomization
Was the treatment clustered?
No
Experiment Characteristics
Sample size: planned number of clusters
180 patient
Sample size: planned number of observations
180 patient
Sample size (or number of clusters) by treatment arms
90 patient in intervention group and 90 patient in control group.
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
Medical Ethic Committee of Islamic Azad University in Iran
IRB Approval Date
2014-08-13
IRB Approval Number
10264713-Q
Post-Trial
Post Trial Information
Study Withdrawal
Intervention
Is the intervention completed?
No
Is data collection complete?
Data Publication
Data Publication
Is public data available?
No
Program Files
Program Files
Reports and Papers
Preliminary Reports
Relevant Papers