The Evaluation of Safety and Efficacy of JWHGWT on Diabetic Neuropathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2009-07-31

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.

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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.

Conditions

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Diabetic Neuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo, 4 g, powder, oral, 3 times a day

JWHGWT

Group Type EXPERIMENTAL

JWHGWT

Intervention Type DRUG

JWHGWT, 4 g, powder, oral, 3 times a day

Interventions

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placebo

placebo, 4 g, powder, oral, 3 times a day

Intervention Type DRUG

JWHGWT

JWHGWT, 4 g, powder, oral, 3 times a day

Intervention Type DRUG

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No