Status:
COMPLETED
Centella Asiatica Selected Triterpenes (CAST) for Diabetic Neuropathy
Lead Sponsor:
Oregon Health and Science University
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Diabetic Neuropathy
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
The purpose of this protocol is to investigate the safety, tolerability and effectiveness of CAST as a treatment for diabetic neuropathy. The primary outcome measure will be Total Neuropathic Symptom ...
Detailed Description
This study is a clinical trial investigating the effect of an herbal supplement called CAST on diabetic neuropathy. CAST is an herb commonly used in traditional Indian medicine. In this tradition, it ...
Eligibility Criteria
Inclusion
- Type II diabetes that is being treated with diet, oral antidiabetic agents and/or insulin
- stable glycemic control over the last 3 months
- evidence of symptomatic symmetrical distal neuropathy
- total symptom score of 4 or more
- stable HbA1c level of less than 8.5 over last three months
Exclusion
- Smokers
- Asymmetrical neuropathy of the trunk and proximal lower limbs
- Presence of foot ulcers
- Peripheral vascular disease (non-palpable foot pulses, intermittent claudication)
- Myopathy
- Causes of neuropathy other than diabetes
- Participation in a study of any investigational drug for diabetic neuropathy within 3 months of the study
- Use of any other product containing CA in the last 3 months
- Starting to use antioxidants or Vitamin B within 1 month before the study
- Severe concomitant diseases including neurological disease
- Pregnancy, lactation or being of child-bearing age without birth control
- HBA1c level higher than 8.5
- Use of any experimental drugs in the three months prior to start of the study
- Use of anti-coagulant therapy (heparin or coumarin based drugs)
- A QTc of more than 500 ms at baseline ECG
- Uncontrollable hypertension, defined as diastolic pressure greater than 110, and systolic pressure greater than 160
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00608439
Start Date
September 1 2007
End Date
August 1 2011
Last Update
November 12 2012
Active Locations (1)
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1
Oregon Health and Science University
Portland, Oregon, United States, 97239