Identification of the probable mechanisms of Duloxetine and Pregabalin involving in treatment of neuropathic pain of type 2 diabetic patients

The comparison of duloxetine and pregabalin effects on plasma concentration of nitric oxide (NO) and inducible nitric oxide synthase (iNOS) in type 2 diabetic patients and the role of these mediators in neuropathic pain

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT2017012932277N1

Enrollment

Registered

2017-07-19

Start date

2017-08-01

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Condition 1: Non-insulin-dependent diabetes mellitus. Condition 2: Pain due to diabetic polyneuropathy. Condition 3: Autonomic neuropathy. Non-insulin-dependent diabetes mellitus Diabetic polyneuropathy Autonomic neuropathy in endocrine and metabolic diseases

Interventions

Intervention 1: Duloxetine group: Duloxetine 30 and 60 mg capsules, formulated by Sobhan pharmaceutical factory, Duloxetine 30 mg capsules will be prescribed once daily at first week, afterward, Dulo

Treatment - Drugs

Duloxetine group: Duloxetine 30 and 60 mg capsules, formulated by Sobhan pharmaceutical factory, Duloxetine 30 mg capsules will be prescribed once daily at first week, afterward, Duloxetine 60 mg cap

Pregabalin group: Pregabalin 75 and 150 mg capsules, formulated by Sobhan pharmaceutical factory, Pregabalin 75 mg capsules will be prescribed twice daily at first week, afterward, Pregabalin 150 mg

Eligibility

Sex/Gender

All

Age

39 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1-Type 2 diabetic patients with neuropathic pain which have the pain score over 4 on Visual Analogue Scale (VAS) for more than 3 months; 2-The age range: 40-60 years; 3- The patients should fill out and sign the consent forms Exclusion criteria: 1-Hypersensitivity to Duloxetine and Pregabalin; 2-Kidney or liver failure; 3-Any other neuropathies (spinal cord injury, discopathy, congenital neuropathy, vocational, hypothyroidism, collagen vascular disease, vasculitis, Paraneoplastic disorders, immunological, alcoholism and drugs induced); 4- Rheumatoid Arthritis; 5-Goat; 6-Epilepsy; 7-Orthopedic complications; 8- Vision disability; 9-Intellectual disorders; 10-Usage of analgesic and anti-inflammatory drugs; 11-Type 1 diabetes; 12-Hypertension; 13-Smoking

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Plasma concentration of Nitric Oxide Synthase. Timepoint: Before drug prescription and on days 30 and 60 after that. Method of measurement: ELISA kit.;Plasma concentration of Nitric oxide. Timepoint: Before drug prescription and on days 30 and 60 after that. Method of measurement: ELISA kit.	—

Secondary

Measure	Time frame
Pain. Timepoint: Before drugs prescription and every week after that. Method of measurement: Visual Analogue Scale (VAS).;?Adverse drug reactions. Timepoint: Every day. Method of measurement: Interview with patients and their reports.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMoosareza Memari

Pharmacology Department, School of Medicine, Shahid Beheshti University of Medical Sciences

reza_memari@sbmu.ac.ir and reza_1117@yahoo.com+98 21 2387 2539

Outcome results

None listed

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