in this study we will comparison between Trigonella foenum- graccum L.( Fenugreek) syrup and honey with placebo in patient with mild asthma which use Ventalex( Salbutamol spray made by Sina Darou) PRN. It is a randomized triple blind study with duration of 4 weeks.Study sample is 90 persons with mild Asthma.At first we complain the study to patient. We will fill demografic information and asthma control questionnire and some essential lab exams.Also the number of drugs they take in a day and frequency of ashtma attacks will consider. They also asked for Fenugreek and its family sensetivity.Seconed visit will take for spirometery to see probable side effects.Final visit will taken one month after the end of study and we will have spirometery and lab exams and asthma control questionnaire again.When we rich to 90 members the study will be stopped and we will analysis the data.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016011325991N1
Registration date:2016-04-02, 1395/01/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-04-02, 1395/01/14
Registrant information
Name
laleh oveidzadeh
Name of organization / entity
ardacan school of traditional medicine
Country
Iran (Islamic Republic of)
Phone
+98 61 5237 9254
Email address
l_oveidzadeh@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research, Shahid Sadoughei University of Medical Sciences
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2017-03-21, 1396/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison between Trigonella Foenum- graccum L.( Fenugreek) syrup and honey with placebo in patient with mild asthma
Public title
The efficacy of Trigonella Foenum- graccum L. in treatment of mild asthma
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: patient with mild asthma in recent year; age between20 to 60; complete the form; haven't recive any CAM throgh the study; don't use any adetive fenugreek- haven't sensetivity to fenugreek and certain allergy; don't use MAO Inh drugs; don't have seasonal allergy; not diabetic; don't have an acute disease in heart or liver or kidneys.
exclusion crieria:pregnancy or breastfeeding; acute diseases; sensetivity or side effect of drug; useing anti coagolant drugs; thyroid diseases; rihnosinositist; smoking and drug abuse
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
The study is triple blind and parallel. The petients inter to the study with simple computeric codes.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ٍEthics committee of Shahid Sadoughei University of Medical Sciences
Street address
Bahonar sq. Shahid Saduoghi Medical Science University
City
Yazd
Postal code
Approval date
2015-11-20, 1394/08/29
Ethics committee reference number
ir.ssu.rec.1394.130
Health conditions studied
1
Description of health condition studied
Asthma
ICD-10 code
j45.9
ICD-10 code description
Asthma
Primary outcomes
1
Description
spirometery tesr
Timepoint
first and second day and a month after study
Method of measurement
spirometer
2
Description
asthma control test
Timepoint
first and a month after study
Method of measurement
st. george questionnaire
Secondary outcomes
1
Description
IL4
Timepoint
first and a month after study
Method of measurement
imunologic test
Intervention groups
1
Description
honey syrup for 4 weeks 10 mg bd which made by Shahid b Beheshti pharmacy university
Category
Treatment - Drugs
2
Description
fenugreek syrup for 4 weeks 5mg bd made by Shahid Beheshti pharmacy university
Category
Treatment - Drugs
3
Description
control: suger syrup 5 mg bd for 4 weeks made by Shahid Beheshti pharmacy university
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Shahid Labafi nezhad Hospital
Full name of responsible person
Dr. laleh oveidzadeh
Street address
Pasdaran- Boostan 9th- Shahid Amir Ebrahimi Ave.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research, Shahid Sadoughei University of Medical Sciences
Full name of responsible person
Dr. Fatemeh Ezoddini
Street address
Central department of Shahid Sadoughei Medical University, Shahid Bahonar Sq.
City
Yazd
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research, Shahid Sadoughei University of Medical Sciences
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
Faculty of Traditional Medicine, Shahid Sadoughei University of Medical Sciences, Ardakan, Yazd
Full name of responsible person
Dr. laleh oveidzadeh
Position
PhD student
Other areas of specialty/work
Street address
Imam Khomeini Ave.
City
Ardakan
Postal code
8916978477
Phone
+98 35 2723 8917
Fax
Email
l_oveidzadeh@ssu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Traditional Medicine, Shahid Sadoughei University of Medical Sciences, Ardakan, Yazd
Full name of responsible person
Dr. Majid Emtiazy
Position
Professer assistant
Other areas of specialty/work
Street address
Imam Khomeini Ave.
City
Ardakan
Postal code
Phone
+98 35 2723 8917
Fax
Email
dr.emtiazy@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Traditional Medicine, Shahid Sadoughei University of Medical Sciences, Ardakan, Yazd
Full name of responsible person
Dr. laleh oveidzadeh
Position
PhD student
Other areas of specialty/work
Street address
Imam Khomeini Ave.
City
Ardakan
Postal code
Phone
+98 35 2723 8917
Fax
Email
l_oveidzadeh@ssu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)