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Centella Asiatica Selected Triterpenes (CAST) for Diabetic Neuropathy

NCT00608439 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2012-11-12

No results posted yet for this study

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.

Conditions

  • Diabetic Neuropathy

Interventions

DRUG

Centella asiatica selected triterpenes (CAST)

Drug provided to subjects in 60 mg capsules. Dose escalation phase: subjects take 2 capsules/day for weeks 1-4, 3 capsules/day for weeks 4-8 and 4 capsules/day weeks 8-12. Subjects remain on highest tolerated dose from week 12 to 52.

OTHER

Placebo

Placebo provided to subjects in 60 mg color-matched capsules. Dose escalation phase: subjects take 2 capsules/day for weeks 1-4, 3 capsules/day for weeks 4-8 and 4 capsules/day weeks 8-12. Subjects remain on highest tolerated "dose" from week 12 to 52.

Sponsors & Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • Jau-Shin Lou, MD, PhD · Oregon Health and Science University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00608439 on ClinicalTrials.gov