Combination of Equisetum Arvense and Palmitoylethanolamide (PEA) for the Management of Patients With Chronic Pain in a Before-after Study

NCT07110480 | Completed Phase 1

• 2 other identifiers: 704/CEnoivita srls
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic pain is a type of pain that lasts or recurs for a period of more than three months. Due to the physical, psychological, and socio-relational consequences of chronic pain for the person experiencing it, it has been recognized as a true pathology in itself. In fact, it interferes with daily activities, causing depression, mistrust, and a general sense of malaise. Acetaminophen or nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or naproxen, are generally used as the first line of treatment for chronic pain. NSAIDs are able to reduce inflammation, which is often linked to the pathology and exacerbates it, as well as alleviate chronic pain. However, if taken in high doses or over a prolonged period, NSAIDs can cause serious side effects, such as irritation of the gastrointestinal mucosa, an increased tendency to bleed, kidney problems, and a high risk of cardiovascular abnormalities. In this context, the present study aims to identify a new treatment useful for managing chronic pain. For this purpose, patients suffering from chronic pain, attending the Alessandria Hospital Company, aged between 18 and 80, and using acetaminophen in the previous 3 months, would be enrolled. Enrolled patients would be administered oral tablets containing 600 mg of palmitoylethanolamide (PEA) and 300 mg of Equisetum arvense L. In detail, recent research has highlighted the anti-inflammatory and immunomodulatory role of PEA, which has a neuroprotective effect, acting on several molecular targets in the central and peripheral nervous systems . Furthermore, PEA is an endogenous agonist of the endocannabinoid system, acting on CB1 and CB2 receptors, allowing proper nerve transmission and regulating the sensation of chronic pain . In addition, numerous studies have described the biological effects of Equisetum A.L. extract, as it plays an important role in the oxidative stress response mechanism and in the activation of SIRT1, which mediates chronic pain Based on this evidence, in the present study, PEA and Equisetum A.L. are administered simultaneously to evaluate their synergistic effect on the modulation of chronic pain.

Conditions

Chronic Pain; Chronic Pain (Back / Neck); Pain (Visceral, Somatic, or Neuropathic); Pain Management

Outcome Measures

Primary Outcomes (2)

• Numerical Pain Rating Scale

  The primary endpoint was the reduction of perceived pain, which was measured using the NPRS at T0, T1, T2, T3. The NPRS (or NRS scale) is a one-dimensional 11-point scale that assesses the intensity of pain in adults, including chronic pain conditions due to rheumatic diseases\]. The scale is composed of a horizontal line, with an interval ranging from 0 to 10, corresponding to "no pain" and "worst imaginable pain", respectively. The NPRS scale can be easily administered both verbally (for example, also by telephone) and graphically.

  - T0: baseline - T1: after 14 days - T2: after 30 days - T3: after 60 days

• Verbal Rating Scale

  The Verbal Rating Scale (VRS) is a pain scale consisting of a list of descriptors that identify the degree of pain intensity. Generally, the scale ranges from "no pain" to "severe pain" or "very intense pain," passing through a series of intermediate adjectives that should gradually capture the nuances of intensity of the painful experience, such as "mild," "moderate," and "severe."

  - T0: baseline - T1: after 14 days - T2: after 30 days - T3: after 60 days

Secondary Outcomes (3)

• measurement of patient perception versus drug treatment

  - T0: baseline - T1: after 14 days - T2: after 30 days - T3: after 60 days

• quantification and description of perceived pain

  - T0: baseline - T1: after 14 days - T2: after 30 days - T3: after 60 days

• Measuring quality of life

  - T0: baseline - T1: after 14 days - T2: after 30 days - T3: after 60 days

Study Arms (1)

AssonalPEA

EXPERIMENTAL

The product evaluated in the following protocol is a new formulation containing 600 mg of PEA and 300 mg of Equisetum arvense L. (Assonal®️PEA) per tablet to reduce the symptoms of chronic pain. Enrolled patients will be advised to take 1 or 2 tablets per day at any time of the day, preferably swallowed with a sip of water. The product should be stored in a cool, dry place, away from localized heat sources and sunlight, and protected from moisture. It is advisable to keep the tablets in the blister pack until ready to take them.

Dietary Supplement: Supplement

Interventions

Supplement DIETARY_SUPPLEMENT

The enrolled patient was advised to take 1 to 2 tablets daily at any time, preferably with a sip of water, as directed by the pharmaceutical company. In detail, starting with the distribution of Assonal®️PEA (T0) by the principal investigator, patients took 2 tablets per day (1 in the morning and 1 in the evening) for the first 15 days of treatment (T1). Treatment continued with 1 tablet per day until the end of the clinical study (T3).

AssonalPEA

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients between 18 and 80 years of age.
• Pain beyond 3 months, even intermittent, timing is necessary to have a pattern of chronic pain.
• Signature of informed consent.
• Paracetamol use in the last 3 months.

You may not qualify if:

• Drug treatment for chronic pain (e.g., acetyl-L-carnitine, tricyclic antidepressants, opioids, antiepileptics) would lead to incorrect interpretation of data.
• Pharmacological treatment for arthritis pain would lead to an incorrect interpretation of the data.
• Psychiatric disorders or cognitive dysfunction in patients with these disorders could result in the completion of questionnaires that are not useful for the final assessment.
• Concomitant severe brain damage.
• Tumours or terminal illnesses.
• Pregnancy or lactation.
• Alcohol or substance abuse.
• Allergies or intolerance to the product as it would cause serious adverse side effects

Sponsors & Collaborators

• noiVita Srls: lead

Study Sites (1)

DAIRI

Alessandria, AL, 15121, Italy

Location

MeSH Terms

Conditions

Chronic Pain; Pain; Agnosia

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: August 7, 2025
• Study Start: July 29, 2024
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: August 7, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)