Comparison of amitriptyline alone and combination of amitriptyline with pregabalin in diabetic neuropathic pain

Randomised, Double-Blind, Cross-Over Study Comparing the Efficacy and Safety of the Combination of Amitriptyline plus Pregabalin vs. Amitriptyline alone in Painful Diabetic Neuropathy

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/02/011841

Enrollment

Registered

2018-02-12

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

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

Interventions

Intervention1: Combination of Amitriptyline plus Pregabalin: Combination of Amitriptyline 10mg plus Pregabalin 75, 150, or 300mg orally once per day is compared with Amitriptyline alone for efficacy a

Eligibility

Inclusion criteria

Inclusion criteria: 1)Presence of type 2 diabetes mellitus 2)No change in anti-diabetic medication for the past 1 month 3)Evidence of painful diabetic neuropathy by: i.Diabetic Neuropathy Symptom Score >1 point ii.Diabetic Neuropathy Examination Score >4 point iii.Vibration perception test and monofilament test iv.Neuropathic pain present for at least 1 month. v.Mean pain intensity of more than 50% by patient assessment by Visual Analog Scale (VAS)

Exclusion criteria

Exclusion criteria: 1)Age below 18 or above 75 years 2)Evidence of renal disease (S. creatinine > 1.5mg/dl) 3)Evidence of liver disease (AST and ALT 3 times upper normal limit with clinical evidence) 4)Pregnant and lactating mothers and women intending pregnancy. 5)Evidence of other causes for neuropathy and painful conditions 6)Epilepsy, psychiatric and cardiac diseases, hypertensives not on treatment, peripheral vascular disease and substance abuse. 7)Intake of anticonvulsants, antidepressants, membrane stabilizers and opioids. 8)Participation in any other clinical trial in the past 30 days

Design outcomes

Primary

Measure	Time frame
VAS scoring of diabetic neuropathic painTimepoint: Every 2 weeks from 2nd to 16th week	—

Secondary

Measure	Time frame
Improvement on Likert scale, PGIC, SF-McGill pain questionnaire,Brief pain inventory, Hamilton rating scale for depression, Quality of night time sleep, neuropathy score, and Adverse eventsTimepoint: Every 2 weeks from 2 to 16 weeks	—

Countries

India

Contacts

Public ContactDr Amitava Chakrabarti

AIIMS, Bhubaneswar

debhota@gmail.com0674-2476011

Outcome results

None listed

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