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

Phase 2

Completed

• Conditions: Health Condition 1: null- Diabetic NeuropathyHealth Condition 2: E114- Type 2 diabetes mellitus with neurological complications

• Registration Number: CTRI/2018/02/011841
• Lead Sponsor: Postgraduate Institute of Medical Education and Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2014-03-31
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 61

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified