Pain in different clinical settings (e.g. arthralgia, primitive neuropathic pain, idiopathic myalgia etc), fasting glycemia below 110 mg/dl Signs and Symptoms Pain in joint, Myalgia
Conditions
Interventions
The randomization sequence was generated by a statistician using STATA 16 software (Stata Statistical Software: Release 16. College Station, TX: StataCorp LLC) and the randomization list was kept hidd
numerical rating scale (NRS) and visual analogue scale (VAS) results
fasting blood glucose assessment
renal and hepatic toxicity assessment by blood test for the evaluation of creatinine level, alanine aminotransferase (ALT) and aspartate aminotransferase (AST).
After 2 months (t1): a
Sponsors
Italian Association of Health Products and Manufacturers - Federsalus
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients of both sexes aged 18-75 years 2. Have arthralgia, primitive neuropathic pain, or idiopathic myalgia 3. Cannot or do not want to take analgesic drugs (non-?steroidal anti-inflammatory drugs) 4. Fasting glycemia below 110 mg/dl 5. Signed informed consent
Exclusion criteria
Exclusion criteria: 1. Pregnant women 2. Women suspected of being pregnant 3. Women who hope to become pregnant 4. Breastfeeding women 5. Patients with allergies 6. Congenital or acquired immunodeficiency syndrome 7. Fasting glycaemia above 110 mg/dl 8. Obese (body mass index >30 kg/m²) 9. Taking pharmacological therapy for diabetes, cardiovascular diseases, systemic chronic disease, or analgesic, anti-inflammatory or food supplements for the pain 10. Considered unsuitable for participation by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Pain measured using the Numerical Rating Scale (NRS) and the Visual Analogue Scale (VAS) at baseline (t0) and after 2 months (t1) 2. Fasting blood glucose in normoglycemic or mildly dysglycaemic subjects measured by taking a blood sample from participants who have fasted for at least 8 hours, at t0 and t1 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Possible hepatic and renal toxicity resulting from oral administration of ALA by the evaluation of creatinine level, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) assessed by blood test at t0 and t2 2. Possible adverse reactions using a form specifically prepared according to the Italian Phytovigilance System (IPS) at t0 and t2 | — |
Countries
Italy
Contacts
Public ContactCristina Esposito
Outcome results
None listed