The Evaluation of Safety and Efficacy of JWHGWT on Diabetic Neuropathy

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00886665

Enrollment

120

Registered

2009-04-23

Start date

2008-07-31

Completion date

2009-07-31

Last updated

2009-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Neuropathy

Keywords

Diabetic Neuropathy, Nerve Conduction Studies, Clinical Trial

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.

Interventions

DRUGplacebo

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

DRUGJWHGWT

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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)

Design outcomes

Primary

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

Secondary

Measure	Time frame
Nerve conduction study	0,12 weeks

Countries

Taiwan

Contacts

Primary ContactChia-I Tsai, master

josepho777@yahoo.com.tw886-4-23592525

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026