The Evaluation of Safety and Efficacy of JWHGWT on Diabetic Neuropathy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Taichung Veterans General Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Taichung Veterans General Hospital
ClinicalTrials.gov Identifier:
NCT00886665
First received: April 21, 2009
Last updated: June 17, 2009
Last verified: April 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Nerve conduction study [ Time Frame: 0,12 weeks ] [ Designated as safety issue: No ]

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
Other Name: placebo
Experimental: JWHGWT Drug: JWHGWT
JWHGWT, 4 g, powder, oral, 3 times a day
Other Name: JWHGWT

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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Chia-I Tsai, Taichung Veterans General Hospital
ClinicalTrials.gov Identifier: NCT00886665     History of Changes
Other Study ID Numbers: grb03484777
Study First Received: April 21, 2009
Last Updated: June 17, 2009
Health Authority: Taiwan: Department of Health

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

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

ClinicalTrials.gov processed this record on August 28, 2014