The purpose of this study was to compare Amitriptyline versus Carbamazepine in the treatment of painful diabetic neuropathy. A total of 60 patients with type 2 diabetes were randomly assigned to receive Amitriptyline, 50 mg/d or Carbamazepine, 200mg, TDS, for six weeks, in a double blind trial. Intensity of pain was evaluated based on brief pain inventory before the study and six weeks after administration of drugs.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138905024435N1
Registration date:2010-12-24, 1389/10/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-12-24, 1389/10/03
Registrant information
Name
Reza Haj Manouchehri
Name of organization / entity
Ahvaz Jundishapour University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1374 3012
Email address
h.manouchehri@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundi Shapour Medical Sciences University
Expected recruitment start date
2009-08-23, 1388/06/01
Expected recruitment end date
2010-08-23, 1389/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Amitriptyline versus Carbamazepine in treatment of painful diabetic neuropathy
Public title
Amitriptyline versus Carbamazepine in the treatment of painful diabetic neuropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 18-65 y/o, confirmed diabetic neuropathy with EMG/NCV
Exclusion criteria: pregnancy, breast feeding, recent MI, allergy to drugs, past hx. of seizure, mood disorder, diabetic cystopathy or gastroparesis, renal or hepatic failure, hypothyroidism.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz Jundi Shapour Medical Sciences University
Street address
Ahvaz
City
Ahvaz
Postal code
Approval date
2009-11-22, 1388/09/01
Ethics committee reference number
3353/20/8/پ
Health conditions studied
1
Description of health condition studied
painful diabetic neuropathy
ICD-10 code
E10
ICD-10 code description
Diabetic polyneuropathy
Primary outcomes
1
Description
painful neuropathy
Timepoint
6 weeks
Method of measurement
brief pain inventory (quantitative scale)
Secondary outcomes
1
Description
drugs complications
Timepoint
6 weeks
Method of measurement
by history and assessment
Intervention groups
1
Description
Amitriptyline, 50 mg/day (daroupakhsh) for 6 weeks
Category
Treatment - Drugs
2
Description
Carbamazepine, 600 mg/day (Sobhan darou) for six weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Street address
Golestan Avenue, Ahvaz
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jundishapour University of Medical Sciences
Full name of responsible person
Research deputy of Ahvaz Jundishapour University of Medical Sciences
Street address
Golestan avenue
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?