The Evaluation of Safety and Efficacy of JWHGWT on Diabetic Neuropathy

Phase 3

• Conditions: Diabetic Neuropathy
• Interventions: Drug: placebo; Drug: JWHGWT

• Registration Number: NCT00886665
• Lead Sponsor: Taichung Veterans General Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-07
• Status Verified: 2009-04
• Study First Submitted: 2009-04-21
• Study First Submitted QC: 2009-04-22
• Study First Posted: 2009-04-23
• Primary Completion: 2009-06
• Last Update Submitted: 2009-06-17
• Last Update Posted: 2009-06-18
• Study Completion: 2009-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	-
JWHGWT	JWHGWT	-

Primary Outcome Measures

Name	Time	Method
Short-form (sf)- McGill pain questionnaire (SF-MPQ)	0, 4, 8,12 weeks

Secondary Outcome Measures

Name	Time	Method
Nerve conduction study	0,12 weeks

Trial Locations

Locations (2)

Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan

China Medical University Hospital; 🇨🇳 Taichung, Taichung / Taichung, Taiwan