The Evaluation of Safety and Efficacy of JWHGWT on Diabetic Neuropathy - Full Text View

Sponsored by:	Taichung Veterans General Hospital
Information provided by:	Taichung Veterans General Hospital
ClinicalTrials.gov Identifier:	NCT00886665

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 III

MedlinePlus related topics: Diabetic Nerve Problems

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	The Evaluation of Safety and Efficacy of JWHGWT on Diabetic Neuropathy

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: Placebo Comparator	Drug: placebo placebo, 4 g, powder, oral, 3 times a day
JWHGWT: Experimental	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

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

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
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
Taiwan, Taichung / Taichung
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

Sponsors and Collaborators

Taichung Veterans General Hospital

Investigators

Principal Investigator:

Chia-I Tsai, master

Taichung Veterans General Hospital

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Taichung Veterans General Hospital ( Chia-I Tsai )
Study ID Numbers:	grb03484777
Study First Received:	April 21, 2009
Last Updated:	April 27, 2009
ClinicalTrials.gov Identifier:	NCT00886665 History of Changes
Health Authority:	Taiwan: Department of Health

Keywords provided by Taichung Veterans General Hospital:

Diabetic Neuropathy
Nerve Conduction Studies
Clinical Trial

Study placed in the following topic categories:

Neuromuscular Diseases
Diabetic Neuropathies
Peripheral Nervous System Diseases
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Diabetes Complications

Additional relevant MeSH terms:

Neuromuscular Diseases
Diabetic Neuropathies
Peripheral Nervous System Diseases
Nervous System Diseases

Diabetes Mellitus
Endocrine System Diseases
Diabetes Complications

ClinicalTrials.gov processed this record on May 06, 2009