Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis Polyphenon E Green tea EGCG Epigallocatechin-galleate Placebo Randomized controlled trial
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 11
Healthy volunteers: no

Brief summary:
The hypothesis is that Polyphenon E can protect brain cells in patients with Multiple Sclerosis. To test this hypothesis we are going to compare the changes in n-Acetyl-Aspartate (a chemical that reflects the number of neurons and their metabolism) over one year between people with MS treated with Polyphenon E at a dose of 400mg twice a day and people with MS treated with a matching sugar pill.

Detailed description:
This will be a double blind placebo controlled trial of Polyphenon E as a treatment for MS.

The primary outcome will be the changes in NAA levels over one year. Secondary outcomes will be changes in brain atrophy over one year. As an exploratory outcome we will correlate changes in NAA levels with free Plasma levels of EGCG 8 hours after the morning dose.

Exploratory outcomes include disability progression by EDSS, MS functional composite components and a cognitive test battery.

Arms:
arm 1: Two capsules of Polyphenon E containing 200mg of EGCG each taken twice a day with food. arm 2: Matching placebo capsules.

Interventions: intervention 1: Polyphenon E intervention 2: Placebo
Intervention descriptions: intervention 1: Polyphenon E is a standardized green tea extract. For this study we will use capsules of Polyphenon E containing 200 mg of EGCG per capsule. Subjects will take two capsules twice a day with food. intervention 2: Matching placebo capsules

Protocol document: