A study to compare effectiveness and safety of Pregabalin with Amitriptyline and Pregabalin with Duloxetine in treatment of nerve pain caused by Diabetes-A Non randomised control study

A Comparative study to evaluate the efficacy and safety of Pregabalin with Amitriptyline vs Pregabalin with Duloxetine in treatment of Diabetic Peripheral Neuropathy at a tertiary care centre -A Non Randomised control study - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/10/074554

Enrollment

Registered

2024-10-01

Start date

Unknown

Completion date

Unknown

Last updated

2024-10-14

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

Conditions

Health Condition 1: E114- Type 2 diabetes mellitus with neurological complications

Interventions

Intervention1: Tablet pregabalin with amitriptyline : pregabalin 50mg with amitriptyline 10mg once daily for 6 weeks. Control Intervention1: tablet pregabalin with duloxetine: pregabalin 50mg with

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patient willing to give informed consent. 2.Age above 18 years of either gender. 3.Patients with Type 2 diabetes mellitus having peripheral neuropathic pain screened by Douleur Neuropathic 4 questionnaire having total pain intensity of more than or equal to 4 points on Numeric Rating Scale who received monotherapy.

Exclusion criteria

Exclusion criteria: 1.Patients with history of epilepsy, depression requiring antidepressants medications. 2.Unstable cardiovascular or serious, hepatic (acute liver injury such as hepatitis or severe cirrhosis), kidney, respiratory diseases, blood disorder, seizure disorder, problems with peripheral vascular disease. 3.Pregnancy/breastfeeding or planning pregnancy during the course of the study. 4.Hypersensitivity to study drugs

Design outcomes

Primary

Measure	Time frame
Efficacy parameters: •Pain intensity using Numeric Rating Scale (NRS-11). •Quality of sleep using Insomnia severity Index. Timepoint: 1st week and 6th week	—

Secondary

Measure	Time frame
Safety is assessed: by monitoring and recording adverse events reported by the patients at any time of the study (CDSCO adverse drug reaction reporting form).Timepoint: 1st week and 6th week	—

Countries

India

Contacts

Public ContactSasidharan j

Bangalore Medical College and Research Institute

mamthashekar67@yahoo.com9448508992

Outcome results

None listed

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