NCT00886665

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2008

Shorter than P25 for phase_3

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 23, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

June 18, 2009

Status Verified

April 1, 2009

Enrollment Period

11 months

First QC Date

April 21, 2009

Last Update Submit

June 17, 2009

Conditions

Diabetic Neuropathy

Keywords

Diabetic NeuropathyNerve Conduction StudiesClinical Trial

Outcome Measures

Primary Outcomes (1)

  • Short-form (sf)- McGill pain questionnaire (SF-MPQ)

    0, 4, 8,12 weeks

Secondary Outcomes (1)

  • Nerve conduction study

    0,12 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: placebo

JWHGWT

EXPERIMENTAL
Drug: JWHGWT

Interventions

placeboDRUG

placebo, 4 g, powder, oral, 3 times a day

Placebo
JWHGWTDRUG

JWHGWT, 4 g, powder, oral, 3 times a day

JWHGWT

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of DM
  • Must have the symptoms of pain or numbness

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

China Medical University Hospital

Taichung, Taichung / Taichung, 40705, Taiwan

RECRUITING

Taichung Veterans General Hospital

Taichung, Taichung, 40705, Taiwan

RECRUITING

Related Links

MeSH Terms

Conditions

Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Chia-I Tsai, master

    Taichung Veterans General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chia-I Tsai, master

CONTACT

886-4-23592525josepho777@yahoo.com.tw

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 21, 2009

First Posted

April 23, 2009

Study Start

July 1, 2008

Primary Completion

June 1, 2009

Study Completion

July 1, 2009

Last Updated

June 18, 2009

Record last verified: 2009-04

Locations

TW(2)