Protocol summary
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Study aim
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Evaluation of the sedative effect of thyme in cough in children with asthma
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Design
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In this double-blind clinical trial, phase 2, 60 children with asthma who have the inclusion criteria are placed in 2 parallel groups of 30 patients using a table of random numbers
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Settings and conduct
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In this study, 60 children with asthma aged 5 to 12 years who referred to the allergy clinic of Ardabil University of Medical Sciences were randomly divided into two groups (30 patients in each group). After obtaining written consent from the parents, general information and cough and fever, wheezing and other symptoms of respiratory infection will be collected. Patients in the intervention group will be given 1 to 4 grams of dried thyme leaf powder prepared as a syrup for a week, at a dose of 20 mg / kg every 8 hours along with routine medical treatment, and the control group will receive routine medical treatment and 2 cc placebo syrup .
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Participants/Inclusion and exclusion criteria
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Having asthma, age between 5-12 years, Lack of chronic disability or illness. Exclusion criteria: Failure to complete the course of treatment
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Intervention groups
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Intervention group: Patients in the intervention group will be given 1 to 4 grams of dried thyme leaf powder prepared as a syrup for a week, at a dose of 20 mg / kg every 8 hours, along prednisolone tablets (1 mg / kg, daily, Abureyhan Co.), salbutamol spray (2 puffs every 3 hours by Caspian Tamin Co), theophylline syrup (4 cc every 6 hours by Elixir Co) with routine medical treatment.. Control group: The control group will receive 2 cc placebo syrup and prednisolone tablets (1 mg / kg, daily, Abureyhan Co.), salbutamol spray (2 puffs every 3 hours by Caspian Tamin Co), theophylline syrup (4 cc every 6 hours by Elixir Co).
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Main outcome variables
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cough
General information
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Reason for update
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Incomplete number of patients
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200505047310N1
Registration date:
2020-06-10, 1399/03/21
Registration timing:
prospective
Last update:
2021-03-11, 1399/12/21
Update count:
2
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Registration date
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2020-06-10, 1399/03/21
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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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2020-08-22, 1399/06/01
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Expected recruitment end date
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2021-06-22, 1400/04/01
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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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Evaluation of sedative effect of thyme on cough in children 5 to 12 years of age with asthma
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Public title
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Evaluation of the sedative effect of thyme in cough in children with asthma
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Having asthma
age between 5-12 years
Lack of chronic disability or illness
Exclusion criteria:
Failure to complete the course of treatment
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Age
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From 5 years old to 12 years old
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Gender
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Both
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Phase
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2
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Groups that have been masked
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- Participant
- Outcome assessor
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization method is a simple randomizing using a table of random numbers, a set of numbers which is completely generated randomly without any specific pattern or order in a table form. Table numbers are read from the left, in a way that even numbers are assigned to intervention A and odd numbers to intervention B. In this way, the researcher touches one of the numbers and moves to the right, then records the numbers and assigns them to different groups. Next, considering the volume of the research sample, aluminum wrapper envelopes are prepared (in order not to clarify the content of the envelopes), each of the random sequences is recorded on a card and placed inside an envelope. To maintain a random sequence, envelopes are numbered in the same way. Finally, the flap of the envelopes are sealed and respectively placed inside a box. To reveal the participants' assigned group, at the beginning of the registration based on the order of eligible participants entry to study, one of the envelopes is opened.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Due to the fact that placebo is used, patients and outcome assessors are unaware of the type of intervention.
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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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2019-08-10, 1398/05/19
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Ethics committee reference number
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1398.242.IR.ARUMS.REC
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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J45
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ICD-10 code description
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Asthma
Primary outcomes
1
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Description
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cough
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Timepoint
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Before and after the intervention
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Method of measurement
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Medical examination
Secondary outcomes
1
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Description
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Fever
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Timepoint
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Before and after the intervention
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Method of measurement
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Thermometer
2
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Description
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wheezing
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Timepoint
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Before and after the intervention
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Method of measurement
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Medical Examination
Intervention groups
1
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Description
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Intervention group: Patients in the intervention group will be given 1 to 4 grams of dried thyme leaf powder prepared as a syrup for a week, at a dose of 20 mg / kg every 8 hours, along prednisolone tablets (1 mg / kg, daily, Abureyhan Co.), salbutamol spray (2 puffs every 3 hours by Caspian Tamin Co), theophylline syrup (4 cc every 6 hours by Elixir Co) with routine medical treatment.
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Category
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Treatment - Drugs
2
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Description
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Control group: Control group will receive 2 cc placebo syrup and prednisolone tablets (1 mg / kg, daily, Abureyhan Co.), salbutamol spray (2 puffs every 3 hours by Caspian Tamin Co), theophylline syrup (4 cc every 6 hours by Elixir Co) with routine medical treatment.
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Category
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Treatment - Drugs
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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Ardabil University of Medical Sciences
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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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Public
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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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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - 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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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable