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

Not yet recruiting

• Conditions: Other specified diabetes mellituswith neurological complications,

• Registration Number: CTRI/2021/02/031068
• Lead Sponsor: UNIVERSITY COLLEGE OF MEDICAL SCIENCES

Brief Summary

This will be a prospective double blind randomized compararive trial 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 diabetic peripheral neuropathy and primary objective is to assess the Numerical Rating Scale (NRS) and Neuropathic Pain Symptom Inventory (NPSI) scores in both the groups at baseline 2nd ,4th,8th and 12th week.Patients with established diagnosis of DPN will be referred from Department of Endocrinology to the pain relief clinic under the Department of Anesthesiology. Patients having a diagnosis of DPN with pain intensity ≥ 4/10 on Numerical Rating Scale for pain (NRS-pain) will be taken up for the study. Following diagnosis of DPN, baseline assessments will be made for pain and quality of life. Two ml venous blood samples will be collected and in total two samples will be extracted and mRNA expression of PPARG and Akt genes will be performed at base line and at 12 weeks of treatment by using Real Time Quantitative PCR. Patients suffering from DPN will be divided into two groups of thirty patients each by random allocation. One group will receive combination of Pregabalin plus Duloxetine and other group will receive Pregabalin monotherapy. Primary outcomes of the trial are to assess the proportion of patients achieving NRS-pain score of ≤ 3/10 following drug therapy i.e. at the end of 12th week in both the groups and neuropathic component of pain using NPSI score in both the groups. Secondary outcome measures the NRS- Sleep score in the 2 groups at various designated intervals, BPI-MSF score in both the groups at various designated intervals, PDQ score in both the groups at various designated intervals, Quality of life using SF-12 score in 2 groups at various designated intervals and modulation in mRNA expressions of genes PPARG & Akt at baseline and after 12 weeks of treatment.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-06-02
• Study Start: 2021-10-02

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 1.Male or female patients’ ≥ 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.
• 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.
• 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.
• 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

Name	Time	Method
the groups	Baseline, 2nd, 4th and 8th and 12th week
2)The neuropathic component of pain using NPSI scores between the two groups	Baseline, 2nd, 4th and 8th and 12th week
1)Proportion of patients achieving NRS Pain score of ≤ 3/10 at the end of 12th week in both	Baseline, 2nd, 4th and 8th and 12th week

Secondary Outcome Measures

Name	Time	Method
NRS-Sleep score,	BPI-MSF score,

Trial Locations

Locations (1)

University college of medical sciences and GTB Hospital; 🇮🇳 East, DELHI, India

University college of medical sciences and GTB Hospital

🇮🇳East, DELHI, India

NIMISHA T

Principal investigator

8281343461

nimisha2292@gmail.com