A comparative study on the effects of oral N-acetylcystein and Pregabalin on the blood level of oxidative stress biomarkers in patients with painful diabetic neuropathy: adouble_blinde randomized clinical trial.
A Comparative study on the effects of oral NAC and Pregabalin on the level of oxidative Biomarkers and Nitrosatian stress
Design
This study is a double-blind randomized clinical trial, phase 2, in which 140 eligible patients will be randomly assigned to the intervention pregabalin and NAC groups.
Settings and conduct
The eligible patients with painfull diabetic neuropathy who will refer to Imam khomeini clinic and Shahid Beheshti hospital in Hamadan during the study period will be enrolled in the trial.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 30 to 70 years old; History of Diabetes mellitus type 2 at least one year ago; Hemoglobin A1C less than or equal to 9; diabetic neuropathy with NDS(Neuropathy Disablity Score) greater than or equal to 6; VAS(Visual analogue scale) for pain at least 4 and NSS(Neuropathy symptom score) greater than or equal to 5; glomerular filteration rate mor than.
Exclusion criteria: type 1 DM; Pregnancy and breast feeding; Diabetic foot ulcer; having a neuropathy fore reasons other than diabetes; History of cerebrovascular disease and discopathy; use other medications to relieve symptoms of neuropathy; use of alcoholic drinks or opioids.
Intervention groups
75 mg of pregabalin every 12 hours for 8 weeks compared with 600 mg of effervescent tablet of N-acetyl cysteine every 12 hour for 8 weeks.
Main outcome variables
VAS, serum level of lipid peroxidation, Nitric oxide, Total antioxidant capacity, thiol, activity of glutathione peroxidase, Catalase, superoxid dismutase.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180814040795N2
Registration date:2019-01-21, 1397/11/01
Registration timing:registered_while_recruiting
Last update:2019-01-21, 1397/11/01
Update count:0
Registration date
2019-01-21, 1397/11/01
Registrant information
Name
Firozeh Sajedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 1931
Email address
f.sajedi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-22, 1397/05/31
Expected recruitment end date
2019-05-21, 1398/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study on the effects of oral N-acetylcystein and Pregabalin on the blood level of oxidative stress biomarkers in patients with painful diabetic neuropathy: adouble_blinde randomized clinical trial.
Public title
A comparative study on the effects of oral N-acetylcystein and Pregabalin on the blood level of oxidative stress biomarkers in patients with painful diabetic neuropathy.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 30 to 70 years old
History of type 2 Diabetes mellitus at least one year ago
Hemoglobine A1C Less than or equal to 9
Diabetic neuropathy with NDS(Neuropathy Disablity Score) greater than or equal to 6, VAS(Visual analogue scale)fore pain at least 4 and NSS(Neuropathy symptom score) greater than or equal to 5
glomerular filtration rate more than 30 cc/min
Exclusion criteria:
Type 1 diabetes
pregnancy or breastfeeding
Diabetic foot ulcer
neuropathy for reasons other than diabetes
History of cerebrovascular disease and discopathy
Use other medications to relieve symptoms of neuropathy
Use of alcoholic drink or opioids
Age
From 30 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients will be unaware of the type of intervention; The physician who will examine the patients will not be aware of the intervention; Therefore, the trial will be run as double -blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan University of Medical sciences
Street address
Shahid Beheshti Hospital, Eram Blvd, Qa'em Square, Four research routes, Hamadan City.
City
Hamadan
Province
Hamadan
Postal code
6517953371
Approval date
2018-06-08, 1397/03/18
Ethics committee reference number
IR.UMSHA.REC.1397.137
Health conditions studied
1
Description of health condition studied
Diabetic Polyneuropathy
ICD-10 code
E11.42
ICD-10 code description
Type 2 diabetes mellitus with diabetic polyneuropathy
Primary outcomes
1
Description
Serum level of lipid peroxidation
Timepoint
Before intervention and 2 month after intervention
Method of measurement
kit
2
Description
serum level of Nitric oxide
Timepoint
Before intervention and 2 month after intervention
Method of measurement
kit
3
Description
serum level of total antioxidant capacity
Timepoint
Before intervention and 2 month after intervention
Method of measurement
kit
4
Description
Catalase activity
Timepoint
Before intervention and 2 month after intervention
Method of measurement
kit
5
Description
Activity of superoxide dismutase
Timepoint
Before intervention and 2 month after intervention
Method of measurement
kit
6
Description
serum level of thiol
Timepoint
Before intervention and 2 month after intervention
Method of measurement
kit
7
Description
Activity of Glutathione peroxidase
Timepoint
Before intervention and 2 month after intervention
Method of measurement
kit
8
Description
visual analogue scale
Timepoint
Before intervention, The end of the first month and The end of the second month
Method of measurement
Indicator
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 600 mg of effervescent tablet of N-acetyi cysteine every12 hours for 8 weeks.
Category
Treatment - Drugs
2
Description
Control group: 75mg Tablet pregabalin every 12 hours for 8 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamadan Imam Khomeini Clinic
Full name of responsible person
Firoozeh Sajedi
Street address
Imam Khomeini clinic, Mirzadeh Eshqi St., Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3832 1371
Email
firozeh.sajedi@yahoo.com
2
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital in Hamadan
Full name of responsible person
Firoozeh Sajedi
Street address
Shahid Beheshti Hospital, Eram Blvd, Qa'em Square, Four research routes, Hamadan City
City
Hamadan
Province
Hamadan
Postal code
6517953371
Phone
+98 81 3838 0704
Email
Firozeh.Sajedi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Hamadan University of Medical Sciences, in front of mardom park, shahid fahmideh Blvd., Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3838 1010
Email
S_Bashirian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Firoozeh Sajedi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Shahid Beheshti Hospital, Eram Blvd-Qa'em Square, Four research routes, Hamadan City
City
Hamadan
Province
Hamadan
Postal code
6517953371
Phone
+98 81 3838 0704
Email
firozeh.sajedi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Firoozeh Sajedi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Shahid Beheshti Hospital, Eram Blvd., Qa'em Square, Four research routes, Hamadan City
City
Hamadan
Province
Hamadan
Postal code
6517953371
Phone
+98 81 3838 0704
Email
firozeh.sajedi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Arman abdi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Shahid Beheshti Hospital, Eram Blvd, Qa'em Square, Four research routes, Hamadan City
City
Hamadan
Province
Hamadan
Postal code
6517953371
Phone
+98 81 3838 0704
Email
armanabdi393@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available