After obtaining written informed consent from eligible patients, and getting an approval from Ethics committee of Ahvaz Jundishapur University of Medical Sciences, a prospective, randomized study will be done with the aim of Compare the efficacy of duloxetine and nortriptyline on patients pain with painful diabetic peripheral neuropathy. This study will be conducted on 122 patients in Golestan Hospital Endocrinology Clinic in Ahvaz City in 2016 year. Inclusion criteria including age greater than 18 years; diabetes type one or two; 24-hour average pain score greater than 40 millimeter; Michigan neuropathy screening instrument scores by at least 3; and electrophysiological findings indicate neuropathy. Exclusion criteria including mood disorder; drug and alcohol abuse; history of epilepsy; pregnant women; peripheral vessels disease; and history of diabetes less than a year. Patients will be randomly allocated into two groups according to table of random numbers. Groups "one” and "two" will receive 30 milligram of duloxetine capsule orally every day for six weeks and 25 milligram of nortriptyline capsule orally every day for six weeks, respectively. Neuropathic pain with visual analogue scale and drugs side effects will measure every week for six weeks.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016031927107N1
Registration date:2016-04-21, 1395/02/02
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-04-21, 1395/02/02
Registrant information
Name
Fatemeh Amiri
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1222 0168
Email address
amiri.fa@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ahvaz Jundishapour University of Medical Sciences
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2017-01-04, 1395/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the efficacy of duloxetine and nortriptyline on patients pain with painful diabetic peripheral neuropathy
Public title
Compare the effect of duloxetine and nortriptyline on diabetics pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age greater than 18 years; diabetes type one or two; 24-hour average pain score greater than 40 millimeter; Michigan neuropathy screening instrument scores by at least 3; and electrophysiological findings indicate neuropathy
Exclusion criteria:
Mood disorder; drug and alcohol abuse; history of epilepsy; pregnant women; peripheral vessels disease; and history of diabetes less than a year
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
122
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study patients will be randomly allocated into two groups according to table of random numbers.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Ethics Committee
City
Ahvaz
Postal code
6135715794
Approval date
2016-01-23, 1394/11/03
Ethics committee reference number
IR.AJUMS.REC.1394.567
Health conditions studied
1
Description of health condition studied
Diabetic Polyneuropathy
ICD-10 code
G63.2
ICD-10 code description
Diabetic Polyneuropathy
Primary outcomes
1
Description
Pain
Timepoint
Every week for six weeks
Method of measurement
visual Analogue Scale Questionnaire
Secondary outcomes
1
Description
Drugs side effects
Timepoint
Every week for six weeks
Method of measurement
Questionnaire
Intervention groups
1
Description
Duloxetine: Dose: 30 mg; Number of using: Forty-two times(once a day); Factory name: Tadbir Kalay-e Jam Company; Manufacturing Country's Name: Iran; Administration: Orally; Administration time: Every day
Category
Treatment - Drugs
2
Description
Nortriptyline:
Dose: 25 mg; Number of using: Forty-two times(once a day); Factory name: Daroupakhsh Company; Manufacturing Country's Name: Iran; Administration: Orally; Administration time: Every day