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.

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.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180814040795N2

Enrollment

140

Registered

2019-01-21

Start date

2018-08-22

Completion date

Unknown

Last updated

2019-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Polyneuropathy. Type 2 diabetes mellitus with diabetic polyneuropathy

Interventions

Intervention 1: Intervention group: 600 mg of effervescent tablet of N-acetyi cysteine every12 hours for 8 weeks. Intervention 2: Control group: 75mg Tablet pregabalin every 12 hours for 8 weeks.

Eligibility

Sex/Gender

All

Age

30 Years to 70 Years

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactFiroozeh Sajedi

Hamedan University of Medical Sciences

firozeh.sajedi@yahoo.com+98 81 3838 0704

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 8, 2026