The usefulness and safety of Pregabalin- nortriptyline and pregabalin-duloxetine fixed dose drug combination when used for relieving pain in patients with diabetic neuropathy

A randomized active controlled trial to assess efficacy, effect on heart rate variability and safety of pregabalin- nortriptyline and pregabalin-duloxetine combination in patients with diabetic neuropathy - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/03/081798

Enrollment

142

Registered

2025-03-06

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-07

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: Pregabalin-duloxetine fixed dose combination: Pregabalin 75 mg -duloxetine 20 mg fixed dose combination to be taken one capsule orally once at night for 8 weeks for relieving pain in fo

Eligibility

Inclusion criteria

Inclusion criteria: Diabetes mellitus Neuropathy

Exclusion criteria

Exclusion criteria: 1. Patients with known epilepsy or neuropsychiatric diseases on antiepileptics or antidepressants like selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine, sertraline, paroxetine) or serotonin and noradrenaline reuptake inhibitors (SNRIs) (eg, duloxetine or venlafaxine) or monoamine oxidase inhibitors 2. Critically ill patients 3. Significant systemic illness - cardiovascular or respiratory disease, liver disease with decompensation including ascites, encephalopathy or variceal haemorrhage, active cancer, or persistent infections. 4. Pregnancy and lactation 5. Alcoholic or any CNS depressant drugs 6. Known hypersensitivity to any of the study medication

Design outcomes

Primary

Measure	Time frame
To assess the efficacy of pregabalin-nortriptyline and pregabalin-low dose duloxetine fixed dose combination in reducing pain in diabetic neuropathyTimepoint: 8 weeks	—

Secondary

Measure	Time frame
1. To assess the alterations in heart rate variability in participants on either interventional medication 2. To detect all the adverse events associated with the medications and assess the causality, type and severity of the noted adverse events Timepoint: 8 weeks	—

Countries

India

Contacts

Public ContactDr Siddhartha Dutta

All India Institute of Medical Sciences Rajkot

siddhartha.dutta87@gmail.com9958462048

Outcome results

None listed

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