Type 2 diabetes is the most common metabolic disease, and its prevalence is increasing, This disease has many complications, among them diabetic neuropathy is considered as one of the most common complications in both type 1 and type 2 diabetes. This study will be done as clinical trial and population are all patients with diabetic neuropathy who have been pre-treated with nortriptyline 25-75 mg (54 patients).The main objective is to compare the effect of duloxetine and nortriptyline for diabetic neuropathy. Inclusion criteria: patients older than 18 years with least 3 years of diabetic record, patients with painful diabetic neuropathy, patients who were pre-treated with nortriptyline 25-75 mg . Exclusion criteria: patients with epilepsy, patients with uncontrolled severe HTN, chronic liver disease or kidney disease, patients with other causes of pain are treated. These patients will not taken drugs for 1 month and again for 3 months on Duloxetine 60 mg. In this study, investigation and interpretation of pain were done on VAS scale (Visual Analogue scale) that is based on pain intensity score. From 3-1 to 6-4 were pointed for mild pain and moderate pain and severe pain score is 9-7. Patients are visited at the end of the third month and are rated based on pain intensity of 9-1and finally total score is summed for each patient and total score of three month is extracted based on the number and based on the severity. Given that the pain intensity in previous period with nortriptyline is compared
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015111113612N7
Registration date:2016-05-05, 1395/02/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-05-05, 1395/02/16
Registrant information
Name
Farzad Najafipour
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7850
Email address
najafipourf@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Tabriz University of Medical Sciences
Expected recruitment start date
2016-03-16, 1394/12/26
Expected recruitment end date
2016-07-15, 1395/04/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparison of Effect of Dulextine and Nortryptiline in Diabetic Neuropathy
Public title
A Comparison of Effect of Dulextine and Nortryptiline in Diabetic Neuropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients older than 18 years are at least 3 years have passed since the risk of diabetes, patients with painful diabetic neuropathy, patients who for at least three months before nortriptyline were 25-75 mg.
Exclusion criteria: patients with epilepsy, patients with uncontrolled HTN severe, chronic liver disease or kidney disease, patients with other causes of pain are treated.
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
54
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 Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
Postal code
Approval date
2016-03-14, 1394/12/24
Ethics committee reference number
TBZMED.REC.1394.1187
Health conditions studied
1
Description of health condition studied
Diabetes 2
ICD-10 code
G63.2
ICD-10 code description
polyneuropathy
Primary outcomes
1
Description
Pain and burning
Timepoint
Baseline, one month after discontinuation of the Nortriptyline, after 3 months of initiating Deloxetine
Method of measurement
Based on questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In all patients, administration of duloxetine 60 mg daily for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
The doctor Farzad Najafipour's office
Full name of responsible person
Doctor Farzad Najafipour
Street address
The doctor Farzad Najafipour's office, Third floor, spring Building, Golgasht Street, Tabriz, East Azerbaijan
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Rashidi
Street address
Vice chancellor for Research of Tabriz University of Medical Sciences,Tabriz University of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
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 Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Farzad Najafipour
Position
Endocrinology and Metabolism/ Associate Professor
Other areas of specialty/work
Street address
Department of Endocrinology, Imam Reza Hospital, Tabriz University of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41333557850
Fax
Email
Najafipourf@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Farzad Najafipour
Position
Endocrinology and Metabolism/Associate Professor
Other areas of specialty/work
Street address
Department of Endocrinology, Imam Reza Hospital, Tabriz university of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41333557850
Fax
Email
Najafipourf@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz Medical University
Full name of responsible person
Dr. Mohammad Rashidian
Position
MD, Resident of Internal Medicine
Other areas of specialty/work
Street address
Imam Reza Hospital, Tabriz University of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
Postal code
Phone
+98 413782751
Fax
Email
malekanimohamad@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)