The Effect of Viola flower Syrup on Cough of Children with Asthma: A Double-Blind Randomized Controlled Trial

Last registered on February 16, 2015
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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

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
December 12, 2014, 9:42 AM EST

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Last updated
February 16, 2015, 3:31 PM EST

Last updated is the most recent time when changes to the trial's registration were published.

Locations

Country
Iran (Islamic Republic of)
Region
Qom city

Primary Investigator

Name
Mohammad Gharehbeglou
Affiliation
Islamic Azad University
Contact Primary Investigator

Other Primary Investigator(s)

PI Name
Mohammad Javad Qasemzadeh
PI Affiliation
Department of Medicine, Qom Branch, Islamic Azad University, Qom, Iran
Contact Investigator

Additional Trial Information

Status
Completed
Start date
2014-10-01
End date
2014-12-17
Keywords
Health
Additional Keywords
Violet, Cough, Children, Asthma
JEL code(s)
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 Javad 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 Javad 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
Sponsors & Partners
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)
Supporting Documents and Materials
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
Analysis Plan

Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
No
Data Collection Complete
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials