Protocol summary
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Study aim
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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
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Design
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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
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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 10; diabetic neuropathy with NDS score greater than or equal to 6, NRS 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
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Intervention groups
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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.
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Main outcome variables
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NRS; 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
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20150629022965N19
Registration date:
2018-08-05, 1397/05/14
Registration timing:
prospective
Last update:
2019-08-15, 1398/05/24
Update count:
1
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Registration date
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2018-08-05, 1397/05/14
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-08-23, 1397/06/01
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Expected recruitment end date
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2019-05-22, 1398/03/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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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
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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 10
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
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Age
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From 30 years old to 70 years old
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Gender
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Both
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Phase
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2
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Groups that have been masked
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Sample size
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Target sample size:
140
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The patients will be randomly assigned to intervention and control groups using block randomization
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-06-09, 1397/03/19
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Ethics committee reference number
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IR.UMSHA.REC.1397.172
Health conditions studied
1
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Description of health condition studied
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Diabetic polyneuropathy
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ICD-10 code
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E11.42
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ICD-10 code description
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Type 2 diabetes mellitus with diabetic polyneuropathy
Primary outcomes
1
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Description
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Serum level of lipid peroxidation
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Timepoint
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Before intervention and 2 month after intervention
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Method of measurement
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Kit
2
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Description
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Serum levels of nitric oxide
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Timepoint
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Before intervention and 2 month after intervention
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Method of measurement
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Kit
3
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Description
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Serum levels of total antioxidant capacity
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Timepoint
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Before intervention and 2 month after intervention
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Method of measurement
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Kit
4
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Description
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Catalase activity
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Timepoint
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Before intervention and 2 month after intervention
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Method of measurement
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Kit
5
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Description
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Activity of superoxide dismutase
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Timepoint
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Before intervention and 2 month after intervention
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Method of measurement
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Kit
6
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Description
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Serum level of thiol
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Timepoint
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Before intervention and 2 month after intervention
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Method of measurement
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Kit
7
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Description
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Activity of Glutathione Peroxidase
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Timepoint
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Before intervention and 2 month after intervention
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Method of measurement
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Kit
8
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Description
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Numeric rating scale
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Timepoint
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Before intervention, weekly until end of the study
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Method of measurement
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Questionnaire
9
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Description
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sleep interference score
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Timepoint
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Before intervention, weekly until end of the study
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Method of measurement
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Questionnaire
10
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Description
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Patient Global Impression of Change
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Timepoint
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Before intervention and 2 month after intervention
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Method of measurement
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Questionnaire
11
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Description
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Clinical Global Impression of Change
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Timepoint
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Before intervention and 2 month after intervention
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Method of measurement
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Questionnaire
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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Control group: 75 mg of pregabalin every 12 hours plus oral placebo every 12 hours for 8 weeks.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Hamedan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available