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.

Phase 3

Recruiting

• Conditions: Diabetic Polyneuropathy.; Type 2 diabetes mellitus with diabetic polyneuropathy; E11.42

• Registration Number: IRCT20180814040795N2
• Lead Sponsor: Hamedan University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 25 February 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum level of lipid peroxidation. Timepoint: Before intervention and 2 month after intervention. Method of measurement: kit.;Serum level of Nitric oxide. Timepoint: Before intervention and 2 month after intervention. Method of measurement: kit.;Serum level of total antioxidant capacity. Timepoint: Before intervention and 2 month after intervention. Method of measurement: kit.;Catalase activity. Timepoint: Before intervention and 2 month after intervention. Method of measurement: kit.;Activity of superoxide dismutase. Timepoint: Before intervention and 2 month after intervention. Method of measurement: kit.;Serum level of thiol. Timepoint: Before intervention and 2 month after intervention. Method of measurement: kit.;Activity of Glutathione peroxidase. Timepoint: Before intervention and 2 month after intervention. Method of measurement: kit.;Visual analogue scale. Timepoint: Before intervention, The end of the first month and The end of the second month. Method of measurement: Indicator.