Clinical study of the effect of oral products of three plants: licorice (Glycyrrhiza glabra), fragrant violet (Viola adorata) and tarpaulin (Operculina turpethum) as an add-on on the intervals and severity of moderate chronic asthma attacks in children and adolescents 6 to 18 years
Evaluation of the effectiveness of anti-asthma herbal composition as a therapeutic supplement in the control of moderate chronic asthma in children and adolescents 6 to 18 years.
Design
Clinical trial with control group, one-side blinded, quasi-random based on national code(even or odd), phase 2 on 40 patients
Settings and conduct
The sampling place is Imam Hossein Hospital clinic. All patients aged 6 to 18 years with moderate chronic asthma are sampled. The drug and placebo are exactly the same and differ from the code. the doctor and patients are blinded. The case group takes the main drug and the control group takes placebo; They should eat 4 tablets daily for 1 month. Breathing test is performed before and after taking the drug and a questionnaire to assess the severity of asthma and quality of life before and after the study is completed.
Participants/Inclusion and exclusion criteria
Entry condition:
All patients between 6 to 18 years with moderate chronic asthma based on the 2018 Nelson Pediatric Textbook (Page 202)
No entry conditions:
1. Simultaneous use of other drugs outside the formal treatment protocol that is effective on the disease.
2. Possible history of underlying cardiovascular, renal, hepatic and biliary tract diseases.
Intervention groups
Both case and control groups will receive standard treatment and in addition to standard treatment, case group will receive herbal product as an adjuvant treatment and control group will receive placebo.
Main outcome variables
Age ; Gender; Number of attacks of shortness of breath per week; Severity of shortness of breath attacks per week; FEV1; FEV1 / FVC; Occurrence of ADR adverse effects
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090808002306N6
Registration date:2021-01-29, 1399/11/10
Registration timing:registered_while_recruiting
Last update:2021-01-29, 1399/11/10
Update count:0
Registration date
2021-01-29, 1399/11/10
Registrant information
Name
Ali Mohammad Sabzghabaee
Name of organization / entity
Isfahan university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7070
Email address
sabzghaba@pharm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-06-21, 1400/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical study of the effect of oral products of three plants: licorice (Glycyrrhiza glabra), fragrant violet (Viola adorata) and tarpaulin (Operculina turpethum) as an add-on on the intervals and severity of moderate chronic asthma attacks in children and adolescents 6 to 18 years
Public title
Evaluation of the effect of herbal anti-asthma product along with standard treatment on the intervals and severity of moderate chronic asthma attacks in children and adolescents 6 to 18 years
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients between 6 and 18 years old with chronic asthma in children and adolescents with moderate severity according to the Nelson Pediatrics textbook published in 2018 (page 202)
Do not use other drugs at the same time and outside the official treatment protocol that is effective on the disease.
No possible history of underlying cardiovascular, renal, hepatic and biliary tract diseases
Exclusion criteria:
Age
From 6 years old to 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the pulmonologist and patients are not aware of the type of drug received (main drug or placebo). The drug and the placebo are exactly the same and are distinguished only by a small code that only the researcher and responsible for data collection (student) know about.
Placebo
Used
Assignment
Parallel
Other design features
In the design of this study, patients were divided into two categories based on the odd and even national code receiving the main drug (odd national code) and control (even national code). The first group receives anti-asthma drugs and the second group receives placebo that is exactly the same with the main drug; And one month after taking the drug, evaluations are done.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Vice chancellery for research, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-12-12, 1399/09/22
Ethics committee reference number
IR.MUI.MED.REC.1399.818
Health conditions studied
1
Description of health condition studied
moderate persistent asthma
ICD-10 code
J45.4
ICD-10 code description
Moderate persistent asthma
Primary outcomes
1
Description
Spiro metric Respiratory Test Index (FEV1).
Timepoint
Spirometry tests are taken from patients before the start of the study and the test is performed again one month after taking the drug.
Method of measurement
Pulmonary indices are recorded by spirometry.
2
Description
Spiro metric Respiratory Test Index (FVC).
Timepoint
Spirometry tests are taken from patients before the start of the study and the test is performed again one month after taking the drug.
Method of measurement
Pulmonary indices are recorded by spirometry.
3
Description
Spiro metric Respiratory Test Index (FEV1/FVC).
Timepoint
Spirometry tests are taken from patients before the start of the study and the test is performed again one month after taking the drug.
Method of measurement
Pulmonary indices are recorded by spirometry.
4
Description
Number of cough attacks per day or week
Timepoint
Before the study and one month after taking the drug
Method of measurement
By asking parents and registering on the data collection form
5
Description
Number of puffs used salbutamol spray per day
Timepoint
Before the study and one month after taking the drug
Method of measurement
By asking parents and registering on the data collection form
6
Description
Severe restrictions on exercise or activity
Timepoint
Before the study and one month after taking the drug
Method of measurement
By asking parents and registering on the data collection form
7
Description
Evaluation of quality of life and asthma control in children and adolescents
Timepoint
Before the study and one month after taking the drug
Method of measurement
Using two asthma control questionnaires completed by parents and children or adolescents.
8
Description
Number of shortness of breath per day or week
Timepoint
Before the study and one month after taking the drug
Method of measurement
By asking parents and registering on the data collection form
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this study, subjects in the case group received 4 packs of 30 anti-asthma pills (containing components: asparagine, hydroxycinnamic acids, glycyrrhizin, salicylic acid, methyl ester, betanitropropionic acid, poline, cycloviolasin, saponins, flavonoids, alkaloids of three plants turbid, aromatic violet and licorice) are delivered. The recipe is two morning pills and two night pills. This herbal compound is produced by Sinafaravar Pharmaceutical Company located in Najafabad, Isfahan.
Category
Treatment - Drugs
2
Description
Control group: The placebo is exactly the same as the main drug produced by Sinafaravar Pharmaceutical Company and is given to the control group for one month with the same prescription.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Children's Hospital
Full name of responsible person
Dr. Mohsen Reisi
Street address
Imam Khomeini
City
Isfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3386 6266
Fax
+98 31 3386 8286
Email
emamhossein_hospital@mui.ac.ir
Web page address
http://www.ehuch.mui.ac.ir
2
Recruitment center
Name of recruitment center
Office of Dr. Majid Keyvanfar, Pediatric Lung Specialist
Full name of responsible person
Dr. Majid Keyvanfar
Street address
Sarvieh Building, next to Tohid Public Parking (23 Banafsheh Dead End), Middle Tohid Street
City
Isfahan
Province
Isfehan
Postal code
8173846154
Phone
+98 31 3131 3083
Email
Keivanfar@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Shaghayegh Haghjoi Javanmard
Street address
Center for Research and Technology, Building No. 4 , Jerib St., Isfahan University of Medical Sciences and Health Services, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
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
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ali Mohammad Sabzghabaee
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmacotherapy and Clinical Toxicology
Street address
Isfahan University of Medical Sciences and Health Services, Hezar Jerib St. , Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 7070
Fax
+98 31 3668 0011
Email
sabzghaba@pharm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ali Mohammad Sabzghabaee
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmacotherapy and Clinical Toxicology
Street address
Isfahan University of Medical Sciences and Health Services, Hezar Jerib St., Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7070
Email
sabzghaba@pharm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ali Mohammad Sabzghabaee
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmacotherapy and Clinical Toxicology
Street address
Isfahan University of Medical Sciences and Health Services, Hezar Jerib St., Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 7070
Email
sabzghaba@pharm.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available