Chronic PainPhase 1/2Assonal®️PEANCT07110480
Combination of Equisetum Arvense and Palmitoylethanolamide (PEA) for the Management of Patients With Chronic Pain in a Before-after Study
A Phase 1/2 study testing Supplement in people with Chronic Pain and Chronic Pain (Back / Neck), run by noiVita Srls at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Pain, Chronic Pain (Back / Neck), Pain (Visceral, Somatic, or Neuropathic)
- What is being tested?
- Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 29 Jul 2024to 30 Apr 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Combination of Equisetum Arvense and Pea for the Management of Chronic Pain
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
- Being tested
- Supplement
- Medical subject headings
- Chronic Pain, Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SupplementDietary 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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: - 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."
Measured: - T0: baseline - T1: after 14 days - T2: after 30 days - T3: after 60 days
Secondary outcomes (3)
measurement of patient perception versus drug treatment
The measurement of patient perception versus drug treatment, which will be measured with the GPE, a scale that assesses patient perception using a 7-point Likert scale. This is a subjective assessment in which the patient indicates how much they feel improved or worsened compared to before treatment (1: Very much worse; 2: Moderately worsened; 3: Slightly improved; 4: No change; 5: Slightly improved; 6: Moderately improved; 7: Much improved). This scale is widely used in clinical trials and clinical practice to assess the effectiveness of therapeutic interventions, particularly in musculoskeletal and rehabilitation settings.
Measured: - T0: baseline - T1: after 14 days - T2: after 30 days - T3: after 60 days
quantification and description of perceived pain
The quantification and description of perceived pain will be assessed using the SF-MPQ. It is a self-assessment questionnaire that al-lows you to have an accurate description of the quality and intensity of the pain that the subject is experiencing. There are 78 items di-vided into 20 subgroups that refer to 4 main categories: the sensory class, the affective class, the valuative class and the miscellaneous class. The SF-MPQ also includes the Pain Intensity Index (PPI) of the standard MPQ and a visual analogue scale (VAS).
Measured: - T0: baseline - T1: after 14 days - T2: after 30 days - T3: after 60 days
Measuring quality of life
Measuring quality of life, described with the EURO-QoL-5D-5L or EQ-5D-5L. The instrument consists of: a 5-dimensional descriptive system (mobility, self-care ability, habitual activities, pain/discomfort, and anxiety/depression), each of which involves a three-point rating scale (no problem=1 point; some problem=2 points; persistent problem=3 points); and a VAS that requires the subject to answer the question, "How healthy do you feel today?" A score of 0 corresponds to the worst health status ever, while 100 equals the best perceived health level. It is possible to combine the scores of the two sections and determine an overall score
Measured: - T0: baseline - T1: after 14 days - T2: after 30 days - T3: after 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start29 Jul 2024
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- noiVita Srls
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07110480
- Sponsor's protocol ID
- 704/CE
- Other IDs
- noivita srls
- Acronym
- Assonal®️PEA
- Status last verified
- Jul 2025
- First submitted
- 24 Jul 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Equisetum Arvense and Pea for the Management of Chronic Pain
- ClinicalTrials.gov ID
- NCT07110480
- Acronym / sponsor ID
- Assonal®️PEA / 704/CE
- Conditions
- Chronic Pain, Chronic Pain (Back / Neck), Pain (Visceral, Somatic, or Neuropathic), Pain Management
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- noiVita SrlsIndustry (pharma, biotech, devices)
- Study start
- 29 Jul 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 7 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AssonalPEA | Experimental | Dietary Supplement: SupplementThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SupplementThe 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). | Dietary supplement | AssonalPEA |
Primary outcome
Numerical Pain Rating Scale
Time frame: - T0: baseline - T1: after 14 days - T2: after 30 days - T3: after 60 days
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.
Verbal Rating Scale
Time frame: - T0: baseline - T1: after 14 days - T2: after 30 days - T3: after 60 days
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."
3 secondary outcomes
measurement of patient perception versus drug treatment
Time frame: - T0: baseline - T1: after 14 days - T2: after 30 days - T3: after 60 days
quantification and description of perceived pain
Time frame: - T0: baseline - T1: after 14 days - T2: after 30 days - T3: after 60 days
Measuring quality of life
Time frame: - T0: baseline - T1: after 14 days - T2: after 30 days - T3: after 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Supplement in people with Chronic Pain and Chronic Pain (Back / Neck), run by noiVita Srls at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Pain Rating Scale (time frame: - T0: baseline - T1: after 14 days - T2: after 30 days - T3: after 60 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.