The Evaluation of Safety and Efficacy of JWHGWT on Diabetic Neuropathy
Primary Purpose
Diabetic Neuropathy
Status
Unknown status
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
placebo
JWHGWT
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Neuropathy focused on measuring Diabetic Neuropathy, Nerve Conduction Studies, Clinical Trial
Eligibility Criteria
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)
Sites / Locations
- China Medical University HospitalRecruiting
- Taichung Veterans General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
JWHGWT
Arm Description
Outcomes
Primary Outcome Measures
Short-form (sf)- McGill pain questionnaire (SF-MPQ)
Secondary Outcome Measures
Nerve conduction study
Full Information
NCT ID
NCT00886665
First Posted
April 21, 2009
Last Updated
June 17, 2009
Sponsor
Taichung Veterans General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00886665
Brief Title
The Evaluation of Safety and Efficacy of JWHGWT on Diabetic Neuropathy
Official Title
The Evaluation of Safety and Efficacy of JWHGWT on Diabetic Neuropathy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Unknown status
Study Start Date
July 2008 (undefined)
Primary Completion Date
June 2009 (Anticipated)
Study Completion Date
July 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Taichung Veterans General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathy
Keywords
Diabetic Neuropathy, Nerve Conduction Studies, Clinical Trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
JWHGWT
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo, 4 g, powder, oral, 3 times a day
Intervention Type
Drug
Intervention Name(s)
JWHGWT
Intervention Description
JWHGWT, 4 g, powder, oral, 3 times a day
Primary Outcome Measure Information:
Title
Short-form (sf)- McGill pain questionnaire (SF-MPQ)
Time Frame
0, 4, 8,12 weeks
Secondary Outcome Measure Information:
Title
Nerve conduction study
Time Frame
0,12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chia-I Tsai, master
Phone
886-4-23592525
Ext
4750
Email
josepho777@yahoo.com.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chia-I Tsai, master
Organizational Affiliation
Taichung Veterans General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung
State/Province
Taichung / Taichung
ZIP/Postal Code
40705
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chia-I Tsai, master
Phone
886-4-23592525
Ext
4750
Email
josepho777@yahoo.com.tw
First Name & Middle Initial & Last Name & Degree
Chia-I Tsai, master
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chia-I Tsai, master
Phone
886-4-23592525
Ext
4750
Email
josepho777@yahoo.com.tw
First Name & Middle Initial & Last Name & Degree
Chia-I Tsai, master
12. IPD Sharing Statement
Links:
URL
http://www3.vghtc.gov.tw/tcm/english-index.htm
Description
Related Info
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The Evaluation of Safety and Efficacy of JWHGWT on Diabetic Neuropathy
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