CTRI/2021/02/031068.

Study name	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
Methods	Unclear blinding from trial registration 2‐arm, combination vs antidepressant‐only RCT 12 weeks
Participants	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 MNSI with score ≤ 3 at the time of screening Patients must have average pain severity of ≥ 4/10 on NRS BPI‐Modified short form ≥ 4 Patients should have stable glycaemic control with HbA1C < 12% Target: 60
Interventions	Combination of tablet pregabalin 75 mg and tablet duloxetine 30 mg pregabalin 75 mg twice a day orally
Outcomes	Sleep Pain Physical function Modulation of mRNA expression of PPARG and Akt gene
Starting date	08 February 2021
Contact information	Dr Ashok Kumar Department of Anaesthesia and Critical Care, second floor University College of Medical Sciences and GTB Hospital, Dilshad Garden, Delhi 110095 East, Delhi, India profashoksaxena2@gmail.com
Notes