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Clinical Trials/CTRI/2021/02/031068
CTRI/2021/02/031068
Not yet recruiting
Phase 4

A Randamized double-blind comparative study evaluating the efficacy of a combination of PREGABALIN and DULOXETINE versus PREGABALIN alone and the modulation of mRNA expression of PPARG and Akt genes in patients of painful Diabetic peripheral neuropathy

IVERSITY COLLEGE OF MEDICAL SCIENCES0 sites0 target enrollmentTBD
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Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Not specified
Sponsor
IVERSITY COLLEGE OF MEDICAL SCIENCES
Status
Not yet recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
IVERSITY COLLEGE OF MEDICAL SCIENCES

Eligibility 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

  • •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
  • •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.

Outcomes

Primary Outcomes

Not specified

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