This study evaluated the efficacy of epalrestat in diabetic peripheral neuropathy and its effects on the central nervous system in diabetic peripheral neuropathy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
72
Epalrestat will be taken orally at a dose of 50mg 3 times a day before meals. In addition, conventional hypoglycemic and oral mecobalamin treatment 0.5mg/ time, 3 times/day, before meals.
Subjects takes mecobalamin 0.5mg orally, 3 times a day.Regular hypoglycemia.
Xiangya Hospital of Central South University
Changsha, Hunan, China
RECRUITINGThe change of resting-state functional Magnetic Resonance Imaging
The change in grey matter volume,white matter area, local gyrification index after 6-months treatment
Time frame: baseline , 6months
Mean change of electromyography
mean change from baseline in nerve conduction velocity(m/s) after 6-months treatment
Time frame: baseline , 6months
Mean change of quantitative somatosensory testing
Mean change of temperature perception threshold(℃) after 6-months treatment
Time frame: baseline , 6months
Mean change of corneal confocal focus
Mean change of nerve fibre density(no./mm2) after 6-months treatment
Time frame: baseline , 6months
Mean change in HbA1c
Mean change of HbA1c(%) after 6-months treatment
Time frame: baseline , 6months
Change of Self-Rating Anxiety Scale
Mean change of Self-Rating Anxiety Scale score after 6-months treatment score.The minimum and maximum values is 25 and 100, which higher scores mean more anxiety.
Time frame: baseline , 6months
Change of Self-Rating Depression Scale
Mean change of Self-Rating Depression Scale score after 6-months treatment.The minimum and maximum values is 25 and 100, which higher scores mean more depression.
Time frame: baseline , 6months
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Mean change of Toronto clinical scoring system
Mean change of Toronto clinical scoring system score after 6-months treatment.The minimum and maximum values is 0 and 19, which higher scores mean more severe neuropathy.
Time frame: baseline , 6months
Mean change of Neuropathic pain scale
Mean change of Neuropathic pain scale score after 6-months treatment.The minimum and maximum values is 0 and 10, which higher scores mean more severe neuropathy.
Time frame: baseline , 6months
Mean change of Michigan neuropathy screening form
Mean change of Michigan neuropathy screening form score after 6-months treatment.The minimum and maximum values is 0 and 23, which higher scores mean more severe neuropathy.
Time frame: baseline , 6months
Mean change of mini-mental state examination
Mean change of mini-mental state examination score after 6-months treatment.The minimum and maximum values is 0 and 30, which lower scores mean more severe cognitive dysfunction.
Time frame: baseline , 6months
Mean change of Montreal Cognitive Assessment
Mean change of Montreal Cognitive Assessment score after 6-months treatment.The minimum and maximum values is 0 and 30, which lower scores mean more severe cognitive dysfunction.
Time frame: baseline , 6months