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The study is to compare how efficiently the two medications, Duloxetine and Gabapentin separately prevent or retard the progression of peripheral nerve damage which is caused by long standing uncontrolled diabetes disease in the patients presenting in the medicine OPD of a tertiary care hospital.

A COMPARATIVE STUDY ON EFFICACY AND SAFETY OF DULOXETINE AND GABAPENTIN AMONG PATIENTS WITH DIABETIC POLYNEUROPATHY - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/11/076634
Enrollment
150
Registered
2024-11-11
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-09

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: duloxetine - Serotonin and noradrenaline reuptake inhibitors SNRI: Tab Duloxetine 60mg one tab od administered to group I daily for 12 weeks Control Intervention1: Gabapentine - Cycli

Sponsors

Rama Medical College Hospital and research centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patient of both the sexes 20-70 years of age, having Diabetes mellitus type 2 having diabetic polyneuropathy pain attending medicine OPD will be included in our study. Cooperative and conscious patient. Patient who will give written and informed consent and and are willing to go for follow up. Patient not taking any previous medication for diabetic neuropathy. Patient willing to undergo all pre and post treatment, investigation and willing to complete the prescribed course of treatment.

Exclusion criteria

Exclusion criteria: Patients having Diabetes mellitus type 2 and is diagnosed with other types of neuropathy and disorders & B12 deficiency will be excluded from the study. Patients who are already on medication for diabetic polyneuropathy. Patients with renal impairment, hepatic impairment and cardiac disease will be excluded from the study. Patients on drugs which increases the blood sugar level eg. steroids, adrenaline. Patients who are planning to conceive will be excluded. Pregnant and lactating women will be excluded. Mentally retarded and with altered state of mind will be excluded. Immunocompromised and drug abuse. Patients of Hepatic impairment. Patients having history of hypersensitivity to any of study drugs.

Design outcomes

Primary

MeasureTime frame
VAS score Physical Examination Biochemical ExaminationTimepoint: Day 0, 4th week, 8th week, 12th week

Secondary

MeasureTime frame
Quality of LifeTimepoint: Day 0, 4th week, 8th week, 12th week

Countries

India

Contacts

Public ContactDr Ruquaiya Khatoon

Rama Medical College Hospital and Research Centre, Kanpur

drnilamnigam@gmail.com9140190479

Outcome results

None listed

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