Protocol summary

Summary
This study aimed to investigate the effect of a combination of herbal ointment on back pain in patients,undergoing angiography.The study population included all patients with angiography and samples are consisted of 80 patients with angiography in amiralmomenin Hospital in Arak that they do not have any complication of angiography and not affected by bleeding disorders and lumbar discopathy and available sampling was used to collect samples. In the intervention group for 2 days(4 times per day)Herbal ointment rubbed on their back and before using the ointment and at the end of the second day pain levels measured with VAS scale.in control group lubricant gel use as placebo.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017050133751N1
Registration date: 2017-06-11, 1396/03/21
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-06-11, 1396/03/21
Registrant information
Name
rezvan ghafarzadegan
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3426 2226
Email address
rghafarzadegan@gmail.com
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of herbal ointment (pepper, rosemary, peppermint) on back pain in patients undergoing angiography
Public title
Effect of herbal ointment on back pain in patients undergoing angiography
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Ready to participate in the study and informed consent form filling Older than 18 and younger than 60 years Having a history of allergic diseases According to his statement, with no mental illness and mental illness was incurable and did not take this drug. Being non-emergency angiography Full patient Consciousness Exclusion criteria: Complications during angiography There is active bleeding disorders Not wanting to get involved in different stages of research History of back pain or surgery on the spine discopathy Systolic blood pressure greater than 190 mm Hg and diastolic blood pressure greater than 110 mm Hg
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
ثبت نشده
Secondary trial Id
ثبت نشده
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of arak University of Medical Sciences
Street address
arak basij square
City
arak
Postal code
Approval date
2015-11-23, 1394/09/02
Ethics committee reference number
ir.arakmu.rec.1394.218

Health conditions studied

1

Description of health condition studied
low back pain
ICD-10 code
R29-8
ICD-10 code description
Diseases of the musculoskeletal system and connective tissue

Primary outcomes

1

Description
pain
Timepoint
daily
Method of measurement
VAS scale

Secondary outcomes

1

Description
BMI
Timepoint
Daily
Method of measurement
Kg & Meter

Intervention groups

1

Description
intervantion group:herbal ointment combination of pepper,peppermint and resemary.constructed by daymond company.use for 2 days(4 times per day)
Category
Treatment - Drugs

2

Description
control group: placebo lubricant gel using for 2 days(4 times per day)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Arak Amiralmomenin Hospital
Full name of responsible person
rezvan ghafarzadegan
Street address
arak basij square
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of arak university of medical sciences
Full name of responsible person
Rezvan Ghafarzadegan
Street address
Basij Square arak
City
arak
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 of arak 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
Arak University of Medical Sciences
Full name of responsible person
Ghazavi Ali
Position
PHD
Other areas of specialty/work
Street address
Basij Square
City
arak
Postal code
Phone
+98 86 3417 3645
Fax
Email
ghazaviali@gmail.com, ghazaviali@arakmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
arak university of medical sciences
Full name of responsible person
rghafarzadegan
Position
master of sciences
Other areas of specialty/work
Street address
arak basij square
City
arak
Postal code
Phone
+98 86 3426 2226
Fax
Email
rghafarzadegan@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
arak university of medical sciences
Full name of responsible person
rghafarzadegan
Position
master of sciences
Other areas of specialty/work
Street address
arak basij square
City
arak
Postal code
Phone
+98 86 3426 2226
Fax
Email
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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