The Evaluation of Safety and Efficacy of JWHGWT on Diabetic Neuropathy

June 17, 2009 updated by: Taichung Veterans General Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taichung, Taiwan, 40705
        • Recruiting
        • Taichung Veterans General Hospital
        • Principal Investigator:
          • Chia-I Tsai, master
        • Contact:
    • Taichung / Taichung
      • Taichung, Taichung / Taichung, Taiwan, 40705
        • Recruiting
        • China Medical University Hospital
        • Principal Investigator:
          • Chia-I Tsai, master
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: placebo
placebo, 4 g, powder, oral, 3 times a day
Experimental: JWHGWT
Drug: JWHGWT
JWHGWT, 4 g, powder, oral, 3 times a day

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Nerve conduction study
Time Frame: 0,12 weeks
0,12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taichung Veterans General Hospital

Investigators

  • Principal Investigator: Chia-I Tsai, master, Taichung Veterans General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Anticipated)

June 1, 2009

Study Completion (Anticipated)

July 1, 2009

Study Registration Dates

First Submitted

April 21, 2009

First Submitted That Met QC Criteria

April 22, 2009

First Posted (Estimate)

April 23, 2009

Study Record Updates

Last Update Posted (Estimate)

June 18, 2009

Last Update Submitted That Met QC Criteria

June 17, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • grb03484777

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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