Clinical Trial: The Evaluation of Safety and Efficacy of JWHGWT on Diabetic Neuropathy

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: The Evaluation of Safety and Efficacy of JWHGWT on Diabetic Neuropathy

Brief Summary: 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.

Detailed Summary:

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.

Sponsor: Taichung Veterans General Hospital

Current Primary Outcome: Short-form (sf)- McGill pain questionnaire (SF-MPQ) [ Time Frame: 0, 4, 8,12 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Nerve conduction study [ Time Frame: 0,12 weeks ]

Original Secondary Outcome: Same as current

Information By: Taichung Veterans General Hospital

Dates:
Date Received: April 21, 2009
Date Started: July 2008
Date Completion: July 2009
Last Updated: June 17, 2009
Last Verified: April 2009