Centella Asiatica Selected Triterpenes (CAST) for Diabetic Neuropathy

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jau-Shin Lou, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00608439
First received: January 28, 2008
Last updated: November 9, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Diabetic Neuropathy
Drug: Centella asiatica selected triterpenes (CAST)
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Centella Asiatica Triterpene Extract for Diabetic Neuropathy -- a Pilot Study

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Total Symptom Score [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Nerve Conduction Study [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Neurological Disability Test [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Quantitative Sensory Test [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 43
Study Start Date: September 2007
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo CAST
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 Names:
  • Centella asiatica
  • Gotu Kola
Active Comparator: Centella asiatica selected triterpenes
Active CAST
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.
Other Name: Sugar pill

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 is used to increase memory, treat wounds and sores, skin diseases, and neurological conditions such as epilepsy. The herb has had growing popularity in the US; parts are sold as the dietary supplement "gotu kola" and used to improve blood circulation and help heal wounds. Unlike many other herbs, CAST has been extensively researched for many of the above conditions. The compounds found in CAST make it a very promising potential treatment for diabetic neuropathy because of its effect on blood circulation and growth of nerves.

Subjects will receive informed consent. They will then be screened for eligibility before entering the study. A medical history will be taken and subjects will have a neurological exam and vital signs taken. Subjects will have their blood drawn and will also give a urine sample for routine testing. Subjects will have an electrocardiogram (ECG) to check their heart. If a subject is a woman who is at risk of getting pregnant, she will have a urine pregnancy test.

If the subject is eligible for participation in the study, they will return for a total of nine additional study visits over the course of a year. Subjects will be randomly assigned to either receive the active supplement (CAST) or a placebo. A placebo is a pill that tastes, looks, and smells like the study drug but has no real medicine (or supplement) in it. Subjects have a 50% chance of receiving the active supplement. Neither the subject nor the study staff will know who receives the active supplement or the placebo. At visits 2, 7 and 10, subjects will get a comprehensive assessment of their neuropathy symptoms. This will include a Neurological Disability Score assessment, a nerve conduction study and a Quantitative Sensory Test.

Subjects enrolled in the study will begin taking their study pills at the beginning of week 1 of the study. During the first 12 weeks, subjects will be asked to increase their dose by one pill every four weeks. Therefore, they will increase the number of CAST or placebo pills from 60mg twice daily to 60mg four times daily, or the highest dose that does not cause side effects. Dr. Lou will monitor subjects for side effects of the study supplement. At each study visit, blood and urine samples will be taken for safety analysis, including liver and kidney function, and glucose control, and an ECG will be done to monitor heart activity. Subjects will be contacted by the study coordinator via phone call once per week during the first three months of the study. During the remainder of the study, they will be called once each month that they are not scheduled for an appointment. Treatment will conclude after one year.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00608439

Locations
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Jau-Shin Lou, MD, PhD Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Jau-Shin Lou, Associate Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00608439     History of Changes
Other Study ID Numbers: R21 AT003668, R21AT003668, R21 AT003668
Study First Received: January 28, 2008
Last Updated: November 9, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Oregon Health and Science University:
CAST
Centella asiatica
Diabetes
Diabetic neuropathy

Additional relevant MeSH terms:
Diabetic Neuropathies
Peripheral Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Nervous System Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on October 23, 2014