NCT00886665

The Evaluation of Safety and Efficacy of JWHGWT on Diabetic Neuropathy

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Taichung Veterans General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Diabetic Neuropathy

Interventions

Type	Name	Description
DRUG	placebo	placebo, 4 g, powder, oral, 3 times a day
DRUG	JWHGWT	JWHGWT, 4 g, powder, oral, 3 times a day

Timeline

• Start date: 2008-07-01
• Primary completion: 2009-06-01
• Completion: 2009-07-01
• First posted: 2009-04-23
• Last updated: 2009-06-18

Locations

2 sites across 1 country: Taiwan