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comparing the benefit of tablet PREGABALIN with tablet DULOXETINE and only tablet PREGABALIN in nerve pain in diabetes and relation with PPARG and Akt gene

Phase 4
Conditions
Health Condition 1: E134- Other specified diabetes mellituswith neurological complications
Registration Number
CTRI/2021/02/031068
Lead Sponsor
IVERSITY COLLEGE OF MEDICAL SCIENCES
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1.Male or female patientsâ?? >= 18 years of age with pain due to diabetic peripheral neuropathy

caused by type -I or II Diabetes mellitus for at least 3 months with confirmed diagnosis

on Michigan Neuropathy Screening instrument with score >=3 at the time of screening.

2.Patients must have average pain severity of >= 4/10 on NRS.

3. Brief Pain Inventory- Modified short form (BPI- MSF) >= 4.

4.Patients should have stable glycemic control with HbA1C < 12%.

Exclusion Criteria

1.Patients who had received duloxetine or pregabalin in the past except for less than 15

days course.

2. Evidence of other sources of pain that may confound the diagnosis or recent history of

surgery.

3.Patients with past history of MI, liver disease, pancreatitis and vasculitis, heart failure,

seizure, & arrhythmia.

4. Patients with evidence of renal impairment, diabetic foot ulcer/gangrene of the foot &

history of alcohol consumption and smoking.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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