The Evaluation of Safety and Efficacy of JWHGWT on Diabetic Neuropathy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetic Neuropathy

Intervention / Treatment
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* Drug: placebo
* Drug: JWHGWT


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* placebo, 4 g, powder, oral, 3 times a day<br>|
| Experimental: JWHGWT<br> | Drug: JWHGWT<br>* JWHGWT, 4 g, powder, oral, 3 times a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-form (sf)- McGill pain questionnaire (SF-MPQ) |  | 0, 4, 8,12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nerve conduction study |  | 0,12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic Neuropathy, Nerve Conduction Studies, Clinical Trial