Protocol summary
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Study aim
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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.
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Design
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A clinical trial with a control group, with parallel groups, double-blind, randomized
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Settings and conduct
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50 eligible children are divided into 2 groups. Patients admitted to the pediatric asthma and allergy clinic of Akbar Hospital, in addition to their standard treatment, receive 0.5 cc herbal drops or a placebo made by a pharmacist for 2 weeks. They receive every 8 hours per kilogram of the child's weight. Follow-up is done on the 3rd and 7th and 14th days by phone and according to the checklist.
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Participants/Inclusion and exclusion criteria
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Children under 7 years of age, confirmation of the diagnosis of mild intermittent asthma by a pediatric immunologist based on the GINA guidelines, having an acute respiratory viral infection.
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Intervention groups
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In a double-blind clinical trial study, children with mild intermittent asthma will be included in the study if they meet the inclusion criteria and do not have the exclusion criteria. 50 eligible children will be divided into 2 groups. In addition to their standard treatment, the patients will receive herbal drops for up to 2 weeks. Or they receive the placebo made by the pharmacist 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.
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Main outcome variables
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The amount of daily cough, the amount of nighttime cough, the amount of salbutamol used , the need for oral corticosteroids, the need for a doctor's visit, the need for hospitalization.
General information
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Reason for update
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making a minor change in the title and method,so that it can show a more specific concept of the research .
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20151230025772N11
Registration date:
2022-12-31, 1401/10/10
Registration timing:
registered_while_recruiting
Last update:
2023-10-05, 1402/07/13
Update count:
1
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Registration date
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2022-12-31, 1401/10/10
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-12-11, 1401/09/20
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Expected recruitment end date
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2023-03-11, 1401/12/20
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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.
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Public title
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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.
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
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
Exclusion criteria:
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
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Age
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To 7 years old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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- Participant
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
50
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-07-27, 1401/05/05
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Ethics committee reference number
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IR.IAU.MSHD.REC.1401.151
Health conditions studied
1
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Description of health condition studied
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asthma
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ICD-10 code
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J44
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ICD-10 code description
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Other chronic obstructive pulmonary disease
Primary outcomes
1
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Description
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cough
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Timepoint
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first visit , the third day, the seventh day, the fourteenth day
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Method of measurement
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Number of coughs per day/cough severity based on visual analog scale
2
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Description
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nighttime wakeup due to coughing
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Timepoint
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first visit , the third day, the seventh day, the fourteenth day
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Method of measurement
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amount
3
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Description
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The amount of salbutamol usage
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Timepoint
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first visit , the third day, the seventh day, the fourteenth day
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Method of measurement
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number of puff per day
4
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Description
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oral corticosteroid need
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Timepoint
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first visit , the third day, the seventh day, the fourteenth day
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Method of measurement
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has/doesn't have
5
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Description
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specialist visit requierment
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Timepoint
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the third day, the seventh day, the fourteenth day
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Method of measurement
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has/doesn't have
6
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Description
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need for hospital admission
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Timepoint
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the third day, the seventh day, the fourteenth day
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Method of measurement
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has/doesn't have
Intervention groups
1
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Description
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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)
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Category
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Treatment - Drugs
2
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Description
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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)
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Zojaj Darman Toos Pharmaceutical company
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Persons
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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It is not yet known if there will be a plan to make this available.
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available