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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 December 12, 2014
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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.

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
On going
Start date
2014-10-01
End date
2014-12-17
Keywords
Health
Additional Keywords
Violet, Cough, Children, Asthma
JEL code(s)
Secondary IDs
Abstract
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.
External Link(s)

Registration Citation

Citation
Gharehbeglou, Mohammad and Mohammad Javad Qasemzadeh. 2014. "The Effect of Viola flower Syrup on Cough of Children with Asthma: A Double-Blind Randomized Controlled Trial." AEA RCT Registry. December 12. https://doi.org/10.1257/rct.580-1.0
Former Citation
Gharehbeglou, Mohammad and Mohammad Javad Qasemzadeh. 2014. "The Effect of Viola flower Syrup on Cough of Children with Asthma: A Double-Blind Randomized Controlled Trial." AEA RCT Registry. December 12. https://www.socialscienceregistry.org/trials/580/history/3244
Sponsors & Partners
Experimental Details

Interventions

Intervention(s)
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.
Intervention Start Date
2014-10-01
Intervention End Date
2014-12-15

Primary Outcomes

Primary Outcomes (end points)
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.
Primary Outcomes (explanation)

Secondary Outcomes

Secondary Outcomes (end points)
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
¬ 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
Experimental Design Details
Randomization Method
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.
Randomization Unit
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.
Was the treatment clustered?
No

Experiment Characteristics

Sample size: planned number of clusters
180 patient
Sample size: planned number of observations
iam sure
Sample size (or number of clusters) by treatment arms
91 patient in intervention group and 91 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