Esq
Minimal clinically important differenceRandomized controlled trialPhysical therapyAdverse effectPlaceboCannabidiolNeuropathic painPeripheral neuropathySleep qualitySmart phoneIn patientAnesthesiaDiabetes mellitusAnxietyMedicine
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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: Sub...
Background: This is a prospective, open-label, drug and dose-controlled study. The primary objective of this study is to evaluate the safety and efficacy of cannabidiol (CBD) sublingual tablets for the treatment of patients with chronic diabetic neuropathic pain. The secondary objects are to evaluate the impact of CBD tablets on sleep quality and anxiety. We describe the effectiveness data at the completion of a 21-day study. Methods: Subjects who met all inclusion/exclusion criteria and met the...