Research, Pure Green Pharmaceuticals, West Bloomfield, 48323, USA
Research Article
Cannabidiol (CBD) For the Treatment of Painful Diabetic Peripheral Neuropathy of the Feet: A Placebo-Controlled, Double-Blind, Randomized Trial
Author(s): Debra Kimless MD, Matthew K. Caloura*, Stephen Goldner and Esq
Background: This is a prospective, randomized, dose-controlled, double-blind, placebo-controlled phase II clinical study for the treatment of patients with painful diabetic peripheral neuropathy (pDPN) of the feet. Safety of cannabidiol (CBD) sublingual tablets was the primary objective. Efficacy of the proprietary water-solubilized CBD sublingual tablets on pain, sleep quality and anxiety were the secondary objectives. This trial was conducted remotely with a 28-day dosing regimen.
Methods: Subjects who met all inclusion/exclusion criteria and a Numerical Pain Rating Scale (NPRS) score of 5 or greater were recruited to participate. Trial subjects were randomized to receive either a 20 mg CBD sublingual tablet or placebo tablet three times a day (TID) for 28 days. Subjects were instructed to answer daily and weekly questions on the provided sm.. View More»
DOI:
10.35248/2155-6156.21.12.879
