Diabetic Neuropathy | The Evaluation of Safety and Efficacy of JWHGWT on Diabetic Neuropathy
Diabetic Neuropathy research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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)
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:placeboplacebo, 4 g, powder, oral, 3 times a day
Drug:JWHGWTJWHGWT, 4 g, powder, oral, 3 times a day
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: July 2008
Completed Date: July 2009
Phase: Phase 3
Primary Outcome: Short-form (sf)- McGill pain questionnaire (SF-MPQ)
Secondary Outcome: Nerve conduction study
Study sponsors, principal investigator, and references
Principal Investigator: Chia-I Tsai, master
Lead Sponsor: Taichung Veterans General Hospital