The goal of this clinical trial is to find out if a new supplement called Normast® 3 can help reduce nerve pain and improve nerve function in adults with diabetic polyneuropathy (DPN). DPN is a common complication of diabetes that damages nerves, often causing burning, tingling, or stabbing pain, as well as problems with the autonomic nervous system, which controls things like sweating and heart r…
The goal of this clinical trial is to find out if a new supplement called Normast® 3 can help reduce nerve pain and improve nerve function in adults with diabetic polyneuropathy (DPN). DPN is a common complication of diabetes that damages nerves, often causing burning, tingling, or stabbing pain, as well as problems with the autonomic nervous system, which controls things like sweating and heart rate.
The main questions this study aims to answer are:
Does taking Normast® 3 lower daily pain levels after 12 weeks of treatment? Does it improve the function of small nerve fibers and the autonomic nervous system compared with a placebo (a look-alike tablet with no active ingredients)? Study design This is a randomized, double-blind, placebo-controlled clinical trial. This means participants are randomly assigned to receive either Normast® 3 or placebo, and neither participants nor researchers will know who is receiving which treatment until the study ends.
Who can take part About 40 adults aged 18 to 80 who have diabetic polyneuropathy affecting both small and large nerve fibers will be enrolled. Participants must have stable diabetes treatment for at least 3 months and be able to take oral medication. People with other nerve diseases, major psychiatric conditions, or serious health problems will not be able to take part.
What participants will do Take Normast® 3 or placebo tablets twice a day for 12 weeks while continuing their usual treatments Complete pain and symptom questionnaires Have neurological examinations including quantitative sensory testing, heart and blood pressure tests, the dynamic sweat test, and small skin biopsies to look at intraepidermal nerve fibers Return for follow-up visits at 12 weeks (end of treatment) and 24 weeks (long-term follow-up) Safety and follow-up Researchers will check participants' safety through blood and urine tests and by monitoring any side effects. Participants can stop the study at any time.
Where the study takes place This study is being conducted at the Department of Human Neuroscience, Sapienza University of Rome (Italy).
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Eligibility Criteria
Inclusion Criteria:
Diagnosis of mixed-fiber diabetic polyneuropathy Provision of signed and dated informed consent Willingness to comply with all study procedures and availability for the duration of the study Male or female participants aged 18 to 80 years Ability to take oral medication Stable p…
Inclusion Criteria:
Diagnosis of mixed-fiber diabetic polyneuropathy Provision of signed and dated informed consent Willingness to comply with all study procedures and availability for the duration of the study Male or female participants aged 18 to 80 years Ability to take oral medication Stable pharmacological treatment during the 3 months before enrollment
Exclusion Criteria:
Concomitant peripheral or central nervous system disease that could interfere with the study objectives Conditions other than diabetes that could affect the peripheral nervous system, including vitamin B12 deficiency, kidney failure, previous neurotoxic therapies, thyroid disease, autoimmune diseases, or familial amyloidosis Cognitive impairment Major psychiatric comorbidities Inflammatory rheumatic diseases Pain due to conditions other than diabetic polyneuropathy Clinically significant disease or condition that could affect efficacy or safety assessments or otherwise preclude study participation, in the investigator's judgment Evidence or history of alcohol or drug abuse, including opioids, amphetamines, benzodiazepines, or cannabinoids Known or suspected unwillingness or inability to comply with the trial protocol or study instructions Inability to communicate meaningfully with trial site staff, including insufficient language skills Pregnancy or lactation Any other reason for exclusion according to the investigator's judgment
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