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Evaluation the clinical effects of short –course herbal drug consist of Honey and zufa on Asthma symptoms and Exacerbation due to viral respiratory infection in Children with mild intermittent Asthma

Protocol summary

Summary
This study as a three blind clinical trial in two groups of intervention and control was completed. 50 children of 7 to 12 years old with the diagnose of mild intermittent asthma by the specialists of Immunology and Allergy were enrolled. The children were randomly assigned to two experimental and control groups. Patients at the beginning of a common cold by expert were examined and history, physical examination and peak flow expiratory using a peak flow meter were recorded, then herbal medicine (combined with honey and extracts of hyssop, mallow, thyme narrow, violets and Khorasani dates, dried figs, licorice, mallow, veneris) was administrated to the intervention group and placebo (a substance like herbs with the same shape,odor, design and color) was administered to the control group. In the intervention group patients according to age received a certain amount of medicinal plants (5 ml every 8 hours).The treatment was continued for 5 days. Again on the third day and the fourteenth day by phone and in seventh day in personal were examined and the information (history, physical examination and peak flow) were noted in the checklist.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201608314976N5
Registration date: 2017-07-22, 1396/04/31
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-07-22, 1396/04/31
Registrant information
Name
Hamid Ahanchian
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3801 2469
Email address
ahanchianh@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
vice chancellor for research, Mashhad University of medical sciences.
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-12-20, 1395/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the clinical effects of short –course herbal drug consist of Honey and zufa on Asthma symptoms and Exacerbation due to viral respiratory infection in Children with mild intermittent Asthma
Public title
effect of herbal drug on respiratoty infection in asthmatic children
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: age of 7 to 12 years, mild to moderate asthma, acute viral upper respiratory tract infection, absence of congenital anomalies, absence of any other disease. exclusion criteria: bacterial infection, drug reaction, inadequate compliance of patient or family in follow up or drug consumption.
Age
From 7 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic committe of Mashhad university of Medical Sciences
Street address
Ghoreyshi Building, Daneshgah streeet
City
mashhad
Postal code
Approval date
2016-01-06, 1394/10/16
Ethics committee reference number
IR.MUMS.FM.REC.1394.374

Health conditions studied

1

Description of health condition studied
asthma
ICD-10 code
J44
ICD-10 code description
chronic obstructive asthma

Primary outcomes

1

Description
cough
Timepoint
0 and 3rd 7th and 14teen days
Method of measurement
numbers

2

Description
awaking during sleep
Timepoint
day 0,3,7,14
Method of measurement
number

Secondary outcomes

1

Description
PEFR (Peak Expirometry Flow Rate) changes
Timepoint
0 3rd days
Method of measurement
Peak Expirometry Flow Rate device

2

Description
needing to adjuant treatment ( montelukast)
Timepoint
day3,7,14
Method of measurement
yes or no

Intervention groups

1

Description
interbention group: Compounds containing honey and hyssop herb extracts, hibiscus, thyme narrow, and jujube Khorasani violets, dried figs, licorice, mallow, veneris witch was produced by pharmacist professor in Emam-Reza pharmacy and with dose of 5 milliliter every 8 hour were prescribed.
Category
Treatment - Drugs

2

Description
control group: placebo (a substance like herbs with the same shape,Odor, design and color ) witch was produced by pharmacist professor in Emam-Reza pharmacy and with dose of 5 milliliter every 8 hour were prescribed.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Dr.hamid ahanchian
Street address
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
mashhad university of medical science
Full name of responsible person
DR mohsen tafaghodi
Street address
mashhad daneshgah street, ghoreishi beelding, vice chencellor for research of mashhad university of medical science
City
Mashhad
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
mashhad university of medical science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamid Ahanchian
Position
Associate professor
Other areas of specialty/work
Street address
Ghaem hospital, Ahmad Abad blvd, Taghiabad sq
City
Mashhad
Postal code
Phone
+98 51 1801 2469
Fax
Email
Ahanchianh@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamid Ahanchian
Position
Associate professor
Other areas of specialty/work
Street address
Ghaem hospital, Ahmad Abad blvd, Taghiabad sq. , Mashhad
City
Mashhad
Postal code
Phone
+98 51 1801 2469
Fax
Email
Ahanchianh@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University odf Medical Sciences
Full name of responsible person
Hamid Ahanchian
Position
Associate professor
Other areas of specialty/work
Street address
Ghaem hospital, Ahmad Abad blvd, Taghiabad sq. , Mashhad iran mashhad Khorasan Iran, Islamic Republic Of
City
Mashhad
Postal code
Phone
+98 51 1801 2469
Fax
Email
Ahanchianh@mums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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