Investigating the short-term effect of herbal combination including chamomile and jujube in reducing mild asthma symptoms in children under 7 years old with viral cold
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized
Settings and conduct
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 14th days by phone and according to the checklist, and on the 7th day in person and spirometry is done.
Participants/Inclusion and exclusion criteria
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.
Intervention groups
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 14th days by phone and according to the checklist, and on the 7th day in person and spirometry is done.
Main outcome variables
The amount of daily cough, the amount of nighttime cough, the amount of salbutamol used, the FEV1/FVC ratio, the need for oral corticosteroids, the need for a doctor's visit, the need for hospitalization.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151230025772N11
Registration date:2022-12-31, 1401/10/10
Registration timing:registered_while_recruiting
Last update:2022-12-31, 1401/10/10
Update count:1
Registration date
2022-12-31, 1401/10/10
Registrant information
Name
Seyyed Abbas Zojaji
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3711 2717
Email address
zojajia881@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-11, 1401/09/20
Expected recruitment end date
2023-03-11, 1401/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of the short-course administration of herbal mixture in asthma symptoms of the common cold in children under 7 years old study
Public title
Effect of the short-course administration of herbal mixture in asthma symptoms of the common cold in children under 7 years old study
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
To 7 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Double blinded
Blinding description
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
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of islamic Azad university -Mashhad Branch
Street address
Shahinfar Medical School . Imam khomeini ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9187147578
Approval date
2022-07-27, 1401/05/05
Ethics committee reference number
IR.IAU.MSHD.REC.1401.151
Health conditions studied
1
Description of health condition studied
asthma
ICD-10 code
J44
ICD-10 code description
Other chronic obstructive pulmonary disease
Primary outcomes
1
Description
cough
Timepoint
first visit , the third day, the seventh day, the fourteenth day
Method of measurement
Number of coughs per day/cough severity based on visual analog scale
2
Description
nighttime wakeup due to coughing
Timepoint
first visit , the third day, the seventh day, the fourteenth day
Method of measurement
amount
3
Description
FEV1/FVC
Timepoint
seventh day
Method of measurement
spirometry
4
Description
The amount of salbutamol usage
Timepoint
first visit , the third day, the seventh day, the fourteenth day
Method of measurement
number of puff per day
5
Description
oral corticosteroid need
Timepoint
first visit , the third day, the seventh day, the fourteenth day
Method of measurement
has/doesn't have
6
Description
specialist visit requierment
Timepoint
the third day, the seventh day, the fourteenth day
Method of measurement
has/doesn't have
7
Description
need for hospital admission
Timepoint
the third day, the seventh day, the fourteenth day
Method of measurement
has/doesn't have
Secondary outcomes
empty
Intervention groups
1
Description
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 14th days by phone and according to the checklist, and on the 7th day in person and spirometry is done.(The composition of the herbal drop,contains 10% of jujuba concentrate, 10% of chamomile concentrate and 80% water as solvent)
Category
Treatment - Drugs
2
Description
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 14th days by phone and according to the checklist, and on the 7th day in person and spirometry is done.(the Placebo drop composition includes 10% starch syrup)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric Asthma and Allergy Clinic of Akbar Mashhad Hospital
Full name of responsible person
Dr.Hamid Ahanchian
Street address
Mashhad, Shahid Fakuri Boulevard, Shahid Javan Square, Shahid Kaveh Boulevard in front of Kaveh 14
City
Mashhad
Province
Razavi Khorasan
Postal code
9177897157
Phone
+98 51 3871 3801
Fax
+98 51 3870 9201
Email
Ahanchianh@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zojaj Darman Toos Pharmaceutical company
Full name of responsible person
Seyyed Abbas Zojaji
Street address
Technology Development Center,Mashhad University of Medical Sciences ,Bo Ali Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9196773113
Phone
+98 51 3851 3590
Email
info@zojaj.club
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zojaj Darman Toos Pharmaceutical company
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University of medical science mashhad branch
Full name of responsible person
Dr.Hamid Ahanchian
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Shahinfar Medical School , Emam Khomeini Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9187147578
Phone
+98 51 3225 0041
Email
Ahanchianh@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zojaj Darman Toos Pharmaceutical Company
Full name of responsible person
Seyed Abbas Zojaji
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Bo Ali Square, Mashhad University of Medical Sciences Technology Development Center
City
Mashhad
Province
Razavi Khorasan
Postal code
9196773113
Phone
+98 51 3711 2611
Fax
Email
info@zojaj.club
Person responsible for updating data
Contact
Name of organization / entity
Zojaj Darman Toos Pharmaceutical Company
Full name of responsible person
Seyed Abbas Zojaji
Position
Proffesor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Bo Ali Square, Mashhad University of Medical Sciences Technology Development Center
City
Mashhad
Province
Razavi Khorasan
Postal code
9196773113
Phone
+98 51 3711 2611
Email
info@zojaj.club
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
It is not yet known if there will be a plan to make this available.