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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20150629022965N19

Enrollment

140

Registered

2018-08-05

Start date

2018-08-23

Completion date

Unknown

Last updated

2019-10-07

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: 75 mg of pregabalin every 12 hours plus 600 mg of effervescent tablet of N-acetyl cysteine every 12 hours for 8 weeks. Intervention 2: Control group: 75 mg of prega

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 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

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

Design outcomes

Primary

Measure	Time frame
Numeric rating scale. Timepoint: Before intervention, weekly until end of the study. Method of measurement: Questionnaire.;Serum level of lipid peroxidation. Timepoint: Before intervention and 2 month after intervention. Method of measurement: Kit.;Serum levels of nitric oxide. Timepoint: Before intervention and 2 month after intervention. Method of measurement: Kit.;Serum levels 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.;Sleep interference score. Timepoint: Before intervention, weekly until end of the study. Method of measurement: Questionnaire.;Patient Global Impression of Change. Timepoint: Before intervention and 2 month after intervention. Method of measurement: Questionnaire.;Clinical Global Impression of Change. Timepoint: Before intervention and 2 month after intervention. Method of measurement: Questionnaire.	—

Measure

Time frame

Numeric rating scale. Timepoint: Before intervention, weekly until end of the study. Method of measurement: Questionnaire.;Serum level of lipid peroxidation. Timepoint: Before intervention and 2 month after intervention. Method of measurement: Kit.;Serum levels of nitric oxide. Timepoint: Before intervention and 2 month after intervention. Method of measurement: Kit.;Serum levels 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.;Sleep interference score. Timepoint: Before intervention, weekly until end of the study. Method of measurement: Questionnaire.;Patient Global Impression of Change. Timepoint: Before intervention and 2 month after intervention. Method of measurement: Questionnaire.;Clinical Global Impression of Change. Timepoint: Before intervention and 2 month after intervention. Method of measurement: Questionnaire.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaryam Mehrpooya

Hamedan University of Medical Sciences

m_mehrpooya2003@yahoo.com+98 81 3838 0717

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026