The Evaluation of Safety and Efficacy of JWHGWT on Diabetic Neuropathy

Diabetic Neuropathy Clinical Trial

Official title:

The Evaluation of Safety and Efficacy of JWHGWT on Diabetic Neuropathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00886665
• Other study ID #: grb03484777
• Status: Recruiting
• Phase: Phase 3
• First received: April 21, 2009
• Last updated: June 17, 2009
• Start date: July 2008
• Est. completion date: July 2009

Study information

• Verified date: April 2009
• Source: Taichung Veterans General Hospital
• Contact: Chia-I Tsai, master
• Phone: 886-4-23592525
• Email: josepho777[@]yahoo.com.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Neuropathy

Intervention

Drug:
• placebo
placebo, 4 g, powder, oral, 3 times a day
• JWHGWT
JWHGWT, 4 g, powder, oral, 3 times a day

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung	Taichung / Taichung
Taiwan	Taichung Veterans General Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Taichung Veterans General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short-form (sf)- McGill pain questionnaire (SF-MPQ)		0, 4, 8,12 weeks	No
Secondary	Nerve conduction study		0,12 weeks	No

External Links

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