Overview

Centella Asiatica Selected Triterpenes (CAST) for Diabetic Neuropathy

Status:
Completed

Trial end date:
2011-08-01

Target enrollment:
0

Participant gender:
All

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 Score. Secondary outcomes will be neurological disability score, nerve conduction measurements and quantitative sensory testing. Statistical analyses will compare changes from baseline for CAST- and placebo-treated groups at both time points, compare effects of CAST at 6 and 12 months and, if numbers permit, compare doses.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Oregon Health and Science University

Collaborator:

National Center for Complementary and Integrative Health (NCCIH)

Criteria

Inclusion Criteria:

1. Type II diabetes that is being treated with diet, oral antidiabetic agents and/or
insulin

2. stable glycemic control over the last 3 months

3. evidence of symptomatic symmetrical distal neuropathy

4. total symptom score of 4 or more

5. stable HbA1c level of less than 8.5 over last three months

Exclusion Criteria:

1. Smokers

2. Asymmetrical neuropathy of the trunk and proximal lower limbs

3. Presence of foot ulcers

4. Peripheral vascular disease (non-palpable foot pulses, intermittent claudication)

5. Myopathy

6. Causes of neuropathy other than diabetes

7. Participation in a study of any investigational drug for diabetic neuropathy within 3
months of the study

8. Use of any other product containing CA in the last 3 months

9. Starting to use antioxidants or Vitamin B within 1 month before the study

10. Severe concomitant diseases including neurological disease

11. Pregnancy, lactation or being of child-bearing age without birth control

12. HBA1c level higher than 8.5

13. Use of any experimental drugs in the three months prior to start of the study

14. Use of anti-coagulant therapy (heparin or coumarin based drugs)

15. A QTc of more than 500 ms at baseline ECG

16. Uncontrollable hypertension, defined as diastolic pressure greater than 110, and
systolic pressure greater than 160