Efficacy and Safety of Praga Formulation in the Treatment of Neuropathic Pain
Trial Parameters
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Praga formulation in the treatment of neuropathic pain.
Eligibility Criteria
Inclusion Criteria: * Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms; * Participants of 18 years and older; * Diagnosis of type 2 or type 1 diabetes for at least 1 year; * No change in antidiabetic medication winthin 3 months; * Diagnosis of painful sensorimotor diabetic polyneuropathy; * Presence of at least one of the following symptoms: i. numbness in the toes, feet and / or legs; ii. paresthesias (tingling and / or neuropathic pain) in the toes, feet and / or legs. * Presence of at least one of the following signs: i. symmetrical hypoesthesia of tactile, thermal or painful sensation (s) in the distal region of the legs; ii. hypoactive or abolished achilles reflexes; * Glycated hemoglobin ≤ 11%; * Score ≥ 12 points on the LANSS pain scale (Leeds Assessment of Neuropathic Symptoms and Signs); j) Participants with moderate to severe pain, a score ≥ 4 on the numerical pain scale (0-10 points); * Participants w