Evaluating the effects of oral N-acetyl cysteine as an adjuvant therapy for pain management and serum level of oxidative stress bio-markers in patients with painful diabetic neuropathy: a double-blind randomized clinical trial
To assess the effect of of oral N-acetyl cysteine as an adjuvant therapy in combination with pregabalin in comparison with placebo on pain management and serum level of oxidative stress biomarkers in patients with painful diabetic neuropathy
Design
This study is a double-blind randomized clinical trial, phase II, in which 140 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients with painful 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 type 2 diabetes at least one year ago; Hemoglobin A1c less than or equal to 9; diabetic neuropathy with NDS score greater than or equal to 6, VAS scores for pain at least 4 and NSS score greater than or equal to 5; glomerular filtration rate more than 30
Exit criteria: Type 1 diabetes; Pregnancy or breastfeeding; Diabetic foot ulcer; Having a neuropathy for 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
Intervention group: 75 mg of pregabalin every 12 hours plus 600 mg of effervescent tablet of N-acetyl cysteine every 12 hours for 8 weeks.
Control group: 75 mg of pregabalin every 12 hours plus oral placebo every 12 hours for 8 weeks.
Main outcome variables
Vas; sleep interference score; PGIC; CGIC; Serum level of lipid peroxidation; nitric oxide; total antioxidant capacity; thiol; activity of glutathione peroxidase; catalase; superoxide dismutase
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150629022965N19
Registration date:2018-08-05, 1397/05/14
Registration timing:prospective
Last update:2018-08-05, 1397/05/14
Update count:1
Registration date
2018-08-05, 1397/05/14
Registrant information
Name
Maryam Mehrpooya
Name of organization / entity
School of Pharmacy,Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3821 8684
Email address
m.mehrpoya@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2019-05-22, 1398/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effects of oral N-acetyl cysteine as an adjuvant therapy for pain management and serum level of oxidative stress bio-markers in patients with painful diabetic neuropathy: a double-blind randomized clinical trial
Public title
Evaluating the effects of oral N-acetyl cysteine as an adjuvant therapy for pain management and serum level of oxidative stress bio-markers in patients with painful diabetic neuropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age: 30 to 70 years old
History of type 2 diabetes at least one year ago
Hemoglobin A1c less than or equal to 9
Diabetic neuropathy with NDS score greater than or equal to 6, VAS scores for pain at least 4 and NSS score greater than or equal to 5
glomerular filtration rate more than 30
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 drinks or opioids
Age
From 30 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
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 Hamedan University of Medical Sciences
Street address
Pharmacy school, Hamadan University of Medical Sciences, in front of Mardom park, Shahid Fahmideh Blvd., Hamedan
City
Hamedan
Province
Hamadan
Postal code
6517838678
Approval date
2018-06-09, 1397/03/19
Ethics committee reference number
IR.UMSHA.REC.1397.172
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 levels of nitric oxide
Timepoint
Before intervention and 2 month after intervention
Method of measurement
Kit
3
Description
Serum levels 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
Questionnaire
9
Description
sleep interference score
Timepoint
Before intervention, The end of the first month and The end of the second month
Method of measurement
Questionnaire
10
Description
Patient Global Impression of Change
Timepoint
Before intervention and 2 month after intervention
Method of measurement
Questionnaire
11
Description
Clinical Global Impression of Change
Timepoint
Before intervention and 2 month after intervention
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 75 mg of pregabalin every 12 hours plus 600 mg of effervescent tablet of N-acetyl cysteine every 12 hours for 8 weeks.
Category
Treatment - Drugs
2
Description
Control group: 75 mg of pregabalin every 12 hours plus oral placebo every 12 hours for 8 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamedan Imam Khomeini clinic
Full name of responsible person
Firoozeh Sajedi
Street address
Imam Khomeini clinic, Mirzadeh Eshqi St. , Hamedan
City
Hamedan
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 of Hamadan
Full name of responsible person
Maryam Mehrpooya
Street address
Shahid Beheshti Hospital, Eram Blvd, Hamadan
City
Hamedan
Province
Hamadan
Postal code
3371-5-65179
Phone
+98 81 3838 0703
Email
m_mehrpooya2003@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
همدان ، بلوار شهيد فهميده ، روبروي بوستان مردم ، دانشگاه علوم پزشكي و خدمات بهداشتي همدان ، دانشكده داروسازي
City
Hamedan
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
Maryam Mehrpooya
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Pharmacy school, Hamadan University of Medical Sciences, in front of Mardom park, Shahid Fahmideh Blvd., Hamedan
City
Hamedan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3838 0717
Email
m_mehrpooya2003@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Maryam Mehrpooya
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Pharmacy school, Hamadan University of Medical Sciences, in front of Mardom park, Shahid Fahmideh Blvd., Hamedan
City
Hamedan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3838 0717
Email
m_mehrpooya2003@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Narges Heydari
Position
دانشجو
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Pharmacy school, Hamadan University of Medical Sciences, in front of Mardom park, Shahid Fahmideh Blvd. Hamedan
City
Hamedan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3425 0419
Email
nargesheydari1996@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
Not applicable
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