Observational Study Aimed at Evaluating the Trend of Neuropathic Pain
NCT ID: NCT06324123
Last Updated: 2024-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
122 participants
OBSERVATIONAL
2023-06-09
2024-06-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Neuropathic pain will me assessed through the Numeric Rating Scale (NRS) questionnaire score.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Patients with neuropathic pain
Patients with acute or chronic neuropathic pain
Peacetil
Nutraceutical supplement Peacetil for a period of 2 months
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Peacetil
Nutraceutical supplement Peacetil for a period of 2 months
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Dysmetabolic polyneuropathy (e.g. diabetic neuropathy),
* Chemotherapy treatment neuropathy,
* Compressive mononeuropathy,
* Radiculopathy,
* Postherpetic and non-postherpetic trigeminal neuralgia;
* The patient must be able to understand the informed consent of the study;
* Must adhere to the procedures established by the study;
* DN4 score \>4 at T0 (month 0);
Exclusion Criteria
* Clinical condition which during the observational study requires the introduction or modification of the dosage of drugs which are also indicated for the treatment of acute or chronic pain
* Introduction or modification of the dosage of drugs used to treat acute and chronic neuropathic pain (including other nutraceuticals) from 30 days before the start of the study until the end of the study.
* Presence of unstable psychiatric illness, cognitive impairment, dementia, or substance abuse that would compromise the participant's ability to provide informed consent, as judged by the investigator;
* Clinically significant unstable medical condition (e.g., cardiovascular instability, systemic infection, untreated thyroid dysfunction, serious laboratory test abnormality, or clinically significant ECG changes) that would pose a risk to the participant if they were to participate in the study, in the judgment of the 'investigator.
18 Years
82 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Istituto Auxologico Italiano
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Istituto Auxologico Italiano
Milan, Lombardy, Italy
ASST Fatebenefratelli Sacco
Milan, , Italy
Fondazione Don Carlo Gnocchi ONLUS
Milan, , Italy
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
23C304
Identifier Type: -
Identifier Source: org_study_id