NCT00608439

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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2007

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 6, 2008

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

November 12, 2012

Status Verified

November 1, 2012

Enrollment Period

3.9 years

First QC Date

January 28, 2008

Last Update Submit

November 9, 2012

Conditions

Diabetic Neuropathy

Keywords

CASTCentella asiaticaDiabetesDiabetic neuropathy

Outcome Measures

Primary Outcomes (1)

  • Total Symptom Score

    one year

Secondary Outcomes (3)

  • Nerve Conduction Study

    one year

  • Neurological Disability Test

    one year

  • Quantitative Sensory Test

    one year

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo CAST

Drug: Centella asiatica selected triterpenes (CAST)

Centella asiatica selected triterpenes

ACTIVE COMPARATOR

Active CAST

Other: Placebo

Interventions

Centella asiatica selected triterpenes (CAST)DRUG

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.

Also known as: Centella asiatica, Gotu Kola
Placebo
PlaceboOTHER

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.

Also known as: Sugar pill
Centella asiatica selected triterpenes

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Diabetic NeuropathiesDiabetes Mellitus

Interventions

Centella asiatica extractSugars

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsEndocrine System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

  • Jau-Shin Lou, MD, PhD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 28, 2008

First Posted

February 6, 2008

Study Start

September 1, 2007

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

November 12, 2012

Record last verified: 2012-11

Locations

US(1)