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Trial record 7 of 756 for:    "Diabetic Neuropathies"

The Evaluation of Safety and Efficacy of JWHGWT on Diabetic Neuropathy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2009 by Taichung Veterans General Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00886665
First Posted: April 23, 2009
Last Update Posted: June 18, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Taichung Veterans General Hospital
  Purpose
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.

Condition Intervention Phase
Diabetic Neuropathy Drug: placebo Drug: JWHGWT Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Evaluation of Safety and Efficacy of JWHGWT on Diabetic Neuropathy

Resource links provided by NLM:


Further study details as provided by Taichung Veterans General Hospital:

Primary Outcome Measures:
  • Short-form (sf)- McGill pain questionnaire (SF-MPQ) [ Time Frame: 0, 4, 8,12 weeks ]

Secondary Outcome Measures:
  • Nerve conduction study [ Time Frame: 0,12 weeks ]

Estimated Enrollment: 120
Study Start Date: July 2008
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00886665


Contacts
Contact: Chia-I Tsai, master 886-4-23592525 ext 4750 josepho777@yahoo.com.tw

Locations
Taiwan
China Medical University Hospital Recruiting
Taichung, Taichung / Taichung, Taiwan, 40705
Contact: Chia-I Tsai, master    886-4-23592525 ext 4750    josepho777@yahoo.com.tw   
Principal Investigator: Chia-I Tsai, master         
Taichung Veterans General Hospital Recruiting
Taichung, Taiwan, 40705
Contact: Chia-I Tsai, master    886-4-23592525 ext 4750    josepho777@yahoo.com.tw   
Principal Investigator: Chia-I Tsai, master         
Sponsors and Collaborators
Taichung Veterans General Hospital
Investigators
Principal Investigator: Chia-I Tsai, master Taichung Veterans General Hospital
  More Information

Additional Information:
Responsible Party: Chia-I Tsai, Taichung Veterans General Hospital
ClinicalTrials.gov Identifier: NCT00886665     History of Changes
Other Study ID Numbers: grb03484777
First Submitted: April 21, 2009
First Posted: April 23, 2009
Last Update Posted: June 18, 2009
Last Verified: April 2009

Keywords provided by Taichung Veterans General Hospital:
Diabetic Neuropathy
Nerve Conduction Studies
Clinical Trial

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Diabetic Neuropathies
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases