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Completed

NCT Number: NCT06324123

Observational Study Aimed at Evaluating the Trend of Neuropathic Pain

The present study aims to evaluate the trend of neuropathic pain in patients treated with Peacetil for a period of two months.

Neuropathic pain will me assessed through the Numeric Rating Scale (NRS) questionnaire score.

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Key information

Age range

18 year–82 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Auxologico Italiano, Milan, Lombardy, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with new or recent diagnosis of acute or chronic neuropathic pain in which the clinician decides to introduce treatment with PEACETIL according to common clinical practice, belonging to one of the following categories:
  • 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

  • Neurological disorders confounding the primary objective;
  • 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.

Treatment and study plan

Peacetil

Other

Nutraceutical supplement Peacetil for a period of 2 months

Primary outcomes

  1. Change in neuropathic pain after two months of treatment with Peacetil

    Time frame: At enrollment and at two months after the start of treatment with Peacetil

    Assessed by the Numerical Rating Scale (NRS) score

Secondary outcomes

  1. Change in neuropathic pain after one month of treatment with Peacetil

    Time frame: At enrollment and at one month after the start of treatment with Peacetil

    Assessed by the Numerical Rating Scale (NRS) score

Sponsors and collaborators

Lead sponsor

Istituto Auxologico Italiano

Other

Registry information

Official study title

Observational Study Aimed at Evaluating the Trend of Neuropathic Pain Through the Reduction of the NRS Questionnaire Score in Patients Treated With PEACETIL

Acronym: NEURATIL

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 21, 2024
Registry last updated
Dec 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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