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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?

Diabetic Neuropathy

Study Interventions

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

Study Arms

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.

Placebo

JWHGWT

Study Status

Unknown status

Start Date: July 2008

Completed Date: July 2009

Phase: Phase 3

Type: Interventional

Design:

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

Collaborator:

More information:https://clinicaltrials.gov/show/NCT00886665

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