Testing the effectiveness and safety of alpha-lipoic acid for pain reductio

Not Applicable

Completed

• Conditions: 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

• Registration Number: ISRCTN89876422
• Lead Sponsor: Italian Association of Health Products and Manufacturers - Federsalus

Brief Summary

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34649217/ (added 08/02/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-21
• Study Completion: 2021-07-30
• Last Update Posted: 21 February 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 210

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Pain measured using the Numerical Rating Scale (NRS) and the Visual Analogue Scale (VAS) at baseline (t0) and after 2 months (t1)<br> 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<br>

Secondary Outcome Measures

Name	Time	Method
<br> 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<br> 2. Possible adverse reactions using a form specifically prepared according to the Italian Phytovigilance System (IPS) at t0 and t2<br>