The Evaluation of Safety and Efficacy of JWHGWT on Diabetic Neuropathy

Taichung Veterans General Hospital

Status and phase

Unknown

Phase 3

Conditions

Diabetic Neuropathy

Treatments

Drug: JWHGWT

Drug: placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00886665

grb03484777

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Clinical diagnosis of DM
Must have the symptoms of pain or numbness

Exclusion criteria

Patient with pregnancy (or child bearing potential),or in lactation
Patient currently taking concomitant TCM medications.
Patient with Drug or alcohol addiction
Patient with medical history of myocardial infarction, cerebro-vascular disease, major trauma, operation 6 months prior to enrollment
Patient with liver dysfunction (SGOT or SGPT>2x ULN)
Patient with renal insufficiency (serum creatinine>1.3mg/dL)