Centella Asiatica Selected Triterpenes (CAST) for Diabetic Neuropathy
Condition: Diabetic Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies
Study type: Interventional
Phase: Phase 2

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.
    

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.
    

Intervention name(s): Centella asiatica selected triterpenes (CAST); Placebo
Intervention type(s): Drug; Other
Intervention description(s): 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.; 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 intervention name(s): Centella asiatica; Gotu Kola; Sugar pill
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: CAST; Centella asiatica; Diabetes; Diabetic neuropathy