This study aimed to determine the Effect of Pentoxifylline of diabetic neuropathy of patients with type 2 diabetic deals.This study is a double blind clinical trial.Type 2 diabetic patients between the ages of 40 to 75 years over an year,are the inclusion criteria for this study,and people with heart,kidney and liver disease,and or with a history of amputation,pregnancy and lactation have been excluded.According to inclusion and exclusion criteria of the study and after confirmation of patient's neuropathy,70 people are divided into two groups of 35 persons to intervention and placebo by block random way.To one group;Pentoxifylline and to another one placebo and vitamin B is given.Before and after intervention,symptoms of distal polyneuropathy will be recorded by A Michigan questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016051827965N1
Registration date:2016-09-23, 1395/07/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-09-23, 1395/07/02
Registrant information
Name
Farhad Hosseini
Name of organization / entity
Qom University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 25 3290 4413
Email address
fhoseini@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy for Research,Qom University of Medical Sciences
Expected recruitment start date
2016-03-19, 1394/12/29
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Pentoxifylline on diabetic neuropathy in patients with type 2 diabetes
Public title
Effect of Pentoxifylline on diabetic neuropathy in patients with type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:type 2 diabetes over a year;age group40-75;Distal polyneuropathy resolutions based on questionnaires Michigan;HBA1C8% -10%
Exclusion criteria:Kidney,liver,and heart failure based on the tests, history and physical exam;High blood pressure more than 160 mm Hg and advanced diabetic Retinopathy;The recent use of drugs for neuropathy {gabapentin , nortriptyline};Fever;Pergnancy and lactation;History of amputation
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
70
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Qom University of Medical Sciences
Street address
Plaque 83,4th Alley,1st Lane,Safashar Street.
City
Qom
Postal code
3716987366
Approval date
2016-05-01, 1395/02/12
Ethics committee reference number
IR.MUQ.REC.1395.12
Health conditions studied
1
Description of health condition studied
type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
FBS
Timepoint
pre and early post-operation
Method of measurement
Based on Labratory
2
Description
HBA1C
Timepoint
pre and early post-operation
Method of measurement
Based on Labratory
Secondary outcomes
1
Description
Distal polyneuropathy
Timepoint
Before and 4 months after the intervention
Method of measurement
Michigan Questionnaire A
Intervention groups
1
Description
The tablet of pentoxifylline 400 mg and 100 mg tablets B1 , twice a day
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shaid Beheshti Hospital
Full name of responsible person
Dr.Parham
Street address
Qom,Shahid Beheshti st.
City
Qom
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy for Research,Qom University of Medical Sciences
Full name of responsible person
Dr.Saghafi
Street address
Safashar
City
Qom
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy for Research,Qom 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
Medical University
Full name of responsible person
Dr.Hosseini
Position
Resident of Internal Medicine
Other areas of specialty/work
Street address
Shahid Behshti Hospital
City
Qom
Postal code
3719964797
Phone
00
Fax
Email
dr.farhadhosseini@gmil.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Medical University
Full name of responsible person
Dr.Parham
Position
Associate Professor of Endocrinology
Other areas of specialty/work
Street address
Shahid Behshti Hospital
City
Qom
Postal code
3719964797
Phone
00
Fax
Email
Mahmoud51dr@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Medical University
Full name of responsible person
Dr.Parham
Position
Associate Professor of Endocrinology
Other areas of specialty/work
Street address
Saheli St.
City
Qom
Postal code
3713649373
Phone
+98 25 3612 2000
Fax
Email
Mahmoud51dr@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)