In order to provide a alternative treatment for relieving the pain and numbness of Diabetes Mellitus patients,Traditional Chinese Medicine powder was tested by subjective questionnaire and objective nerve conduction velocity study. Liver and kidney functions were tested to provided safety profiles.
120 participants with diabetic neuropathy were screened in endocrine and metabolism clinics of Taichung Veterans General Hospital and Chinese Medical University Hospital . Subjects were randomly distributed into a double-blind, 12 weeks, placebo-controlled procedure. Subjects were measured by MNSI, SF-BPI, SF-36, SF -MCQ, NCV, AC sugar, HbA1c, lipid profiles, liver and kidney functions. Safety evaluations including GPT and creatinine revealed no deterioration after treatment. Several domains in MNSI, SF-BPI, SF-36, SF -MPQ questionnaires revealed significant improvements. F-wave in peroneal, tibial nerves and distal latency in tibial nerve in objective nerve conduction studies revealed significant improvements.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
China Medical University Hospital
Taichung, Taichung / Taichung, Taiwan
RECRUITINGTaichung Veterans General Hospital
Taichung, Taichung, Taiwan
RECRUITINGShort-form (sf)- McGill pain questionnaire (SF-MPQ)
Time frame: 0, 4, 8,12 weeks
Nerve conduction study
Time frame: 0,12 weeks
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