Health Condition 1: E134- Other specified diabetes mellituswith neurological complications
Conditions
Interventions
Intervention1: Combination of Tablet PREGABALIN 75 mg and Tablet DULOXETINE 30 mg: Combination of Tablet PREGABALIN 75 mg and Tablet DULOXETINE 30 mg from the start of recruitment of patients till 12
Sponsors
UNIVERSITY COLLEGE OF MEDICAL SCIENCES
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)Proportion of patients achieving NRS Pain score of â?¤ 3/10 at the end of 12th week in both the groups 2)The neuropathic component of pain using NPSI scores between the two groupsTimepoint: Baseline, 2nd, 4th and 8th and 12th week | — |
Secondary
| Measure | Time frame |
|---|---|
| NRS-Sleep score, BPI-MSF score, PDQ score, SF-12 score Modulation of mRNA expression of PPARG and Akt gene at baseline and at the end of 12th weekTimepoint: Baseline, 2nd, 4th and 8th and 12th week | — |
Countries
India
Contacts
Public ContactNIMISHA T
UNIVERSITY COLLEGE OF MEDICAL SCIENCES AND GTB HOSPITAL
Outcome results
None listed