NCT07110480

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

Combination of Equisetum Arvense and Pea for the Management of Chronic Pain

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: noiVita Srls · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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).

Timeline

• Start date: 2024-07-29
• Primary completion: 2025-04-30
• Completion: 2025-04-30
• First posted: 2025-08-07
• Last updated: 2025-08-07

Locations

1 site across 1 country: Italy