Comparison of the effect of gabapentin and evening primrose oil with gabapentin and placebo on the pain of peripheral neuropathy in patients with type 2 diabetes.
Comparison of the effect of gabapentin and golden oil of gabapentin and placebo on the severity of pain due to peripheral neuropathy in two groups of intervention and control group
Comparison of the effect of gabapentin and golden oil of gabapentin and placebo on the duration of pain caused by peripheral neuropathy in two groups of intervention and control group
Comparison of the effect of gabapentin and golden oil of gabapentin and placebo on the quality of pain caused by peripheral neuropathy in the intervention group and the control group
Design
In this study, patients with diabetes neuropathy who are eligible for inclusion in the study who are referred to the Diabetes Clinic are selected. Participants are divided into two intervention and control groups based on permutation blocks.
Settings and conduct
The present study is a triple blind clinical trial study. So that the subjects and the researcher will be unaware of the type of drug they receive, and the statistician will have access to the data coded by the supervisor. The researcher referred to Diabetes Clinic of Neyshabur in 96 years after obtaining the necessary preparation for the research and obtaining a formal introduction from Sabzevar University of Medical Sciences. After introducing and expressing the purpose of the study, type 2 diabetic patients referred to the Diabetes Clinic During the monthly visits, there are complaints about neuropathy and then they are examined by a specialist physician and if there are clinical signs of polyneuropathy for introduction into the study.
Participants/Inclusion and exclusion criteria
Entry requirements
The history of diabetes for at least 5 years
There is a pain for more than three months
No entry
Presence of ulcer in the leg
Infection in the foot
Intervention groups
The intervention group is treated with Olive oil at a dose of 1000 mg twice daily for three months and gabapentin (300 mg) daily. The control group was treated with gabapentin mg (300) and placebo twice a day for three months.
Main outcome variables
Intensity of pain
Duration of pain
Olive oil
Age
gender
Duration of diabetes
Cigarette
blood pressure
Pain quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171212037853N1
Registration date:2018-01-30, 1396/11/10
Registration timing:registered_while_recruiting
Last update:2018-01-30, 1396/11/10
Update count:0
Registration date
2018-01-30, 1396/11/10
Registrant information
Name
zohre nasrabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4263 8003
Email address
nasrz1@nums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of gabapentin and evening primrose oil with gabapentin and placebo on the pain of peripheral neuropathy in patients with type 2 diabetes.
Public title
Effect of Flower Magnum Oil on Diabetes Mellitus Neuropathy.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with diabetic neuropathy
Exclusion criteria:
All diabetic patients with heart failure
All diabetic patients with renal failure
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Qualified individuals are divided into two intervention and control groups based on randomized blocks.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Subjects and researchers will be unaware of the type of drug they receive, and the statistician will have access to the data coded by the supervisor.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Sabzevar University of Medical Sciences
Street address
Tawhid Township
City
Sabzevar
Province
Razavi Khorasan
Postal code
کد پستی: 9613873136
Approval date
2017-11-22, 1396/09/01
Ethics committee reference number
IR.MEDSAB.REC.1396.75
Health conditions studied
1
Description of health condition studied
Diabetic neuropathy
ICD-10 code
E11.42
ICD-10 code description
Type 2 diabetes mellitus with diabetic polyneuropathy
Primary outcomes
1
Description
Pain Score in McGill's Revised Questionnaire (SF-MPQ-2)
Timepoint
Measuring the pain before the intervention and after the intervention
Method of measurement
Revised McGill Pain Questionnaire (SF-MPQ-2)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group is treated with Olive oil at a dose of 1000 mg twice a day for three months and gabapentin (300 mg) one night. Magnesium oil is produced by Barij Essence Company.
Category
Treatment - Drugs
2
Description
Control group:The control group is treated with gabapentin (300) mg per day and placebo twice a day for three months.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes Clinic
Full name of responsible person
Souqandi Safiyah
Street address
Hakim Hospital, Khayyam Clinic
City
Neyshabour
Province
Razavi Khorasan
Postal code
93177-58489
Phone
+98 51 4263 8001
Email
NASRZ1@NUMS.AC.IR
Web page address
https://portal.nums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Curt Fereshte
Street address
Deputy of Research and Technology of the University of Medical Sciences Campus, Boulevard Nuclear Martyrs, Above the Memorial of the Anonymous Martyrs
City
Sabzevar
Province
Razavi Khorasan
Postal code
کد پستی: 9617913114-
Phone
+98 51 4401 8319
Fax
+98 51 4401 8319
Email
VCResearch@medsab.ac.ir
Web page address
http://www.medsab.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Nasrabadi Zohre
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Hakim Hospital,Neyshabour
City
Neyshabour
Province
Razavi Khorasan
Postal code
93177-58489
Phone
+98 51 4221 1343
Email
nasrz1@nums.ac.ir
Web page address
https://portal.nums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Nasrabadi Zohreh
Position
Masters Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Hakim Hospital Neyshaboor
City
Neyshabour
Province
Razavi Khorasan
Postal code
93177-58489
Phone
+98 51 4221 1343
Email
nasrz1@nums.ac.ir
Web page address
https://www.nums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Nasrabadi Zohre
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Hakim Hospital,Neyshabour
City
Neyshabour
Province
Razavi Khorasan
Postal code
93177-58489
Phone
+98 51 4221 1343
Email
NASRZ1@NUMS.AC.IR
Web page address
https://www.nums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data can be shared after unidentifiable
When the data will become available and for how long
Six months after printing results
To whom data/document is available
Researchers of academic and academic institutions
Under which criteria data/document could be used
It is allowed to use any kind of analysis on the data
Allowed to use data in studies conducted in Iran