Protocol summary

Summary
The main purpose of this study is to achieve the most logical treatment among the common medications for diabetic neuropathy. In a randomized clinical trial among patients referred to diabetes clinic, 240 patients with painful diabetic neuropathy are selected and randomly divided into 3 groups. All the patients have neuropathic pain for at least a month in accordance with the marked inclusion and exclusion criteria . In these three groups, respectively,pregabaline 150 mg , carbamazepine 400 mg and venlafaxine150 mg is prescribed. Obtaining knowingly consent form from the patient and if the patient does not wish to continue, is knowingly excluded. A questionnaire about drug side effects is given to the patient to record drug side effects. At the beginning of the first day and 30th day, laboratory studies and pain measurement in these patients are measured and compared. At the end therapeutic response and complications rates in the three groups are compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201302188323N6
Registration date: 2013-04-06, 1392/01/17
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-04-06, 1392/01/17
Registrant information
Name
Nazanin Razazian
Name of organization / entity
Neurology Department of Kermanshah Faculty of Medicine
Country
Iran (Islamic Republic of)
Phone
+98 83 1427 3409
Email address
nrazazian@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2013-03-21, 1392/01/01
Expected recruitment end date
2013-05-22, 1392/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A study of comparison of pregabalin, carbamazepine and venlafaxine efficacy to relief painful diabetic neuropathy
Public title
Treatment of diabetic neuropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion critreia (Diabetic neuropathy (san antonio critria); Satisfacation ;Not using effective drugs in diabetic neuropathy; No history from seizure; VAS more than 40mm; No history from renal and liver disease , GBS and anemia) Exclusion criteria (Any abnormality in lab test and vital signs; Use antipsychotic drugs or electrical shoch in 30 days ago; Use antidepressant drugs in 14 days ago; Use caspian and lidocain in 7 days ago; Pregnancy and lactation)
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 240
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
Kermanshah University of Medical Science
Street address
Shahid Beheshti Street,Kermanshah
City
Kermanshah
Postal code
7313714567
Approval date
2012-11-21, 1391/09/01
Ethics committee reference number
38629

Health conditions studied

1

Description of health condition studied
Diabetic neuropathy
ICD-10 code
G60-G64
ICD-10 code description
Polyneuropathies and other disorders of the peripheral nervous system

Primary outcomes

1

Description
Pain due to diabetic neuropathy
Timepoint
first day , 30th day
Method of measurement
PPI , VAS

Secondary outcomes

1

Description
Changes in sleep and mood
Timepoint
first day , 30th day
Method of measurement
Questionnaire

Intervention groups

1

Description
Tab venlafaxine 75 mg twice a day for 1 month
Category
Treatment - Drugs

2

Description
Cap Pregabaline 150mg daily for 1 month
Category
Treatment - Drugs

3

Description
Tab Carbamazepine 200mg twice a day for a month
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Diabet Clinic of Kermanshah
Full name of responsible person
Baziyar Maryam MD, Rezvan madani Fateme MD
Street address
Taleghani Hospital, Shahid Beheshti Street, Kermanshah ,
City
Kermanshah

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah Univesity Of Medical Science
Full name of responsible person
Mohebi Ahmad
Street address
Kermanshah ,Shahid Beheshti Street
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah Univesity Of Medical Science
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
Kermanshah University Of Medical Science
Full name of responsible person
Razazian Nazanin MD
Position
Neurologist
Other areas of specialty/work
Street address
Emam Reza Hospital, Kermanshah
City
Kermanshah
Postal code
7313713497
Phone
+98 83 1427 6310
Fax
+98 83 1427 6309
Email
nrazazian@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University Of Medical Science
Full name of responsible person
Razazian Nazanin MD
Position
Neurologist
Other areas of specialty/work
Street address
Emam Reza Hospital, Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 1427 6310
Fax
Email
nrazazian@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University Of Medical Sciences
Full name of responsible person
Razazian Nazanin MD
Position
Neurologist
Other areas of specialty/work
Street address
Emam Reza Hospital, Kermanshah
City
Kermanshah
Postal code
7313713497
Phone
+98 83 1427 6310
Fax
008314276309
Email
nrazazian@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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