The study was double-blind clinical trial population test all patients with painful diabetic neuropathy are caused by hospital clinic of Ayatollah Rohani visit and sample selection by statistical consultant Mr. plan, as random and using computer matching list case number and the type of treatment desired (known as A and B for each treatment group) were determined and the researcher placed, inclusion criteria: patients over 18 years of age and At least three years have passed since the risk of diabetes and with pdn (painful diabetic neuropathy)For at least a month are.Exclusion criteria: patients with epilepsy, htn uncontrolled and chronic liver disease or renal failure and patients treated for other causes pain in another part of their body.Patients will be divided into two groups(An equal number 40), and Both groups will be 5 weeks under medical treatment. so that a randomly treated with Nortriptyline 25 mg and Duloxetine placebo and another group will be treated with Duloxetine 20 mg and Nortriptyline placebo, methods and interpretation of changes in pain according to VAS (visual analogue scale will be, all patients taking the drug every week during the phone call will follow
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201512265692N8
Registration date:2016-02-24, 1394/12/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-02-24, 1394/12/05
Registrant information
Name
Mohammad ali Bayani
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1223 4651
Email address
m.bayani@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research- Babol University of Medical Sciences
Expected recruitment start date
2016-02-20, 1394/12/01
Expected recruitment end date
2017-06-22, 1396/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of nortriptyline and duloxetine for diabetic neuropathy type 2
Public title
Efficacy of nortriptyline and duloxetine for diabetic neuropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients over 18 years of age and At least three years have passed since the risk of diabetes and with pdn (painful diabetic neuropathy)For at least a month are. exclusion criteria: patients with epilepsy, htn uncontrolled and chronic liver disease or renal failure and patients treated for other causes pain in another part of their body.
Age
No age limit
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)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
As random and using computer matching list case number and the type of treatment desired (known as A and B for each treatment group) were determined and the researcher placed
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Ganj afrooz Street- University of Medical Sciences, Department of Research and Technology
City
Babol
Postal code
47176-41367
Approval date
2015-12-06, 1394/09/15
Ethics committee reference number
MUBABOL.REC.1394.208
Health conditions studied
1
Description of health condition studied
Diabet
ICD-10 code
E10,E11,E1
ICD-10 code description
Diabetes mellitus
Primary outcomes
1
Description
Neuropathic pain
Timepoint
Before the intervention, the duration of the intervention for 35 days, at the end of intervention
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Possible side effects of each drug
Timepoint
During the study period and at the end of the study
Method of measurement
According to Patients
Intervention groups
1
Description
Intervention Group: nortriptyline, 25 mg tablets(Pharmaceutical Amin),Daily for 35 nights with a number Doluxetine placebo for 35 nights
Category
Treatment - Drugs
2
Description
control Group: Doluxetine, capsules 20 mg(Pharmaceutical Amin),Daily for 35 nights with a number nortriptyline placebo one night for 35 nights
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Rohani Hospital-Endocrinology clinic
Full name of responsible person
MohammadAli Bayani(Professor of Endocrinology and Metabolism, Dr.)