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

noiVita Srls

Status and phase: Completed; Phase 2; Phase 1

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

Treatments: Dietary Supplement: Supplement

Study type: Interventional

Funder types: Industry

Identifiers

NCT07110480

noivita srls (Other Identifier)

704/CE

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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50 participants in 1 patient group

AssonalPEA

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Supplement