This study is a randomized, parallel, open-label, multicenter, phase IV clinical trial to assess the efficacy and safety of pregabalin and alpha-lipoic acid combination compared with each monotherapy in patients with diabetic peripheral neuropathy for 12 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
151
Pusan National University Hospital
Busan, South Korea
Chosun University Hospital, School of Medicine, Chosun University
Gwangju, South Korea
visual analogue scale (VAS)
Time frame: 12 weeks
visual analogue scale (VAS)
Time frame: 6 weeks
visual analogue scale (VAS) reduction rate of more than 30%
Time frame: 6 weeks, 12 weeks
visual analogue scale (VAS) reduction rate of more than 50%
Time frame: 6 weeks, 12 weeks
brief pain inventory Korean version, BPI-K
Time frame: 6 weeks, 12 weeks
total symptom score, TSS
Time frame: 6 weeks, 12 weeks
pain detect questionnaire, PD-Q
Time frame: 6 weeks, 12 weeks
3 level version of Euro-Qol-5 dimensions, EQ-5D-3L
Time frame: 6 weeks, 12 weeks
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Dongtan Sacred Heart Hospital, Hallym University College of Medicine
Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Gyeonggi-do, South Korea
The Catholic University of Korea, Incheon ST. Mary's Hospital
Incheon, South Korea
Jeju National University College of Medicine
Jeju City, South Korea
Jeonbuk National University Hospital
Jeollabuk-do, South Korea
Asan Medical Center, University of Ulsan College of Medicine
Seoul, South Korea
Inje University Sanggye Paik Hospital
Seoul, South Korea
Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine
Seoul, South Korea
...and 4 more locations