Purpose: Treatment
Study is a single arm study.
Inclusion criteria: every male or female between 20-55 years old who have low back pain more than 3 months.
. Exclusion criteria: the age >55 and<20 years old, pregnancy and breast feeding.
People in study: patient who Referred to Neurosurgery Clinic in Mostafa khomeiny Hospital.
Target sample size: 60
Intervention: Wild mint cap 500 mg
Intervention time: TDS after meal for 28 days
Study outcomes: pain, disability, dyspepsia.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014042217390N1
Registration date:2014-05-31, 1393/03/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-05-31, 1393/03/10
Registrant information
Name
Nafiseh Hoseiny Yekta
Name of organization / entity
Shahed University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2612 6787
Email address
nyekta@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahed University of Medical Sciences
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2014-06-20, 1393/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of effect of Wild mint product in low back pain because of dyspepsia
Public title
The effect of wild mint on low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: every male or female between 20-55 years old who have LBP more than 3 months.
Exclusion criteria: the age >55 and < 20.spinal tumor, neurologic symptoms, pregnancy and breast feeding.
Age
From 20 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of shahed university
Street address
Shahed University of Medical Sciences , Opposite of Imam Khomeiny Shrine
City
Tehran
Postal code
14561345
Approval date
2014-03-03, 1392/12/12
Ethics committee reference number
41/195144
Health conditions studied
1
Description of health condition studied
Low back pain
ICD-10 code
M54.5
ICD-10 code description
lumbago
Primary outcomes
1
Description
Pain
Timepoint
before intervention.2 week after intervention.4week after intervention.8week after intervention
Method of measurement
Numerical system
2
Description
Disability
Timepoint
before intervention.2 week after intervention.4week after intervention.8week after intervention
Method of measurement
Oswestry questioner
3
Description
Dyspepsia
Timepoint
Before intervention .8week after intervention
Method of measurement
Reorientation of medical education(ROME3) questioner about dyspepsia
Secondary outcomes
empty
Intervention groups
1
Description
Intervention is Wild mint cap 500 mg TDS after meal for 28 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mostafa Khomeiny hospital
Full name of responsible person
Nafiseh Hoseiny Yekta
Street address
Italia avenue.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahed University of Medical Sciences
Full name of responsible person
Elham Emaratkar
Street address
Opposite of Imam Khomeiny shrine
City
Tehran
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, Shahed 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
Shahed University of Medical Sciences
Full name of responsible person
Nafiseh Hoseiny Yekta
Position
PhD student
Other areas of specialty/work
Street address
Opposite of Imam Khomeiny shrine
City
Tehran
Postal code
14561345
Phone
+98 21 5567 8943
Fax
Email
nyekta@shahed.ac.ir; hyekta@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University of Medical Sciences
Full name of responsible person
Younes Rohany
Position
Neurosurgery
Other areas of specialty/work
Street address
Opposite of Imam Khomeiny shrine
City
Tehran
Postal code
14561345
Phone
+98 21 5567 8934
Fax
Email
yrohany@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahed university
Full name of responsible person
Nafiseh Hoseiny yekta
Position
PhD student
Other areas of specialty/work
Street address
Opposite of Imam khomeiny shrine
City
Tehran
Postal code
14561345
Phone
+98 21 5567 8942
Fax
Email
nhyekta@yahoo.com; nyekta@shahed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)