Efficacy And Tolerability Of Alpha Lipoic Acid And Vitamin B Preparation In Carpal Tunnel Syndrome
Summary
The goal of this clinical trial is to assess the effectiveness and safety of an oral combination of alpha lipoic acid (ALA) and vitamin B complex in treating mild to moderate carpal tunnel syndrome (CTS) in adults. The main questions it aims to answer are: * Does the combination of ALA and vitamin B improve nerve function (based on electrodiagnostic studies) in patients with CTS? * Does this treatment reduce CTS-related symptoms and improve quality of life? * What side effects, if any, do participants experience while taking the treatment? Researchers will compare the combination of ALA and vitamin B to a placebo (a look-alike substance that contains no active drug) to evaluate its effectiveness. Participants will: * Take the ALA and vitamin B combination or a placebo once daily for 6 months. * Attend clinic visits at the start of the study, after 3 months, and after 6 months for physical examinations, nerve conduction studies, and to complete questionnaires about their symptoms and quality of life. * Receive follow-up phone calls and reminder messages to ensure medication compliance and attendance at scheduled visits.
Timeline
- Start
- 2023-12-01
- Primary completion
- 2024-09-30
- Completion
- 2024-09-30
Publications
- Background Padua L, LoMonaco M, Gregori B, Valente EM, Padua R, Tonali P. Neurophysiological classification and sensitivity in 500 carpal tunnel syndrome hands. Acta Neurol Scand. 1997 Oct;96(4):211-7. doi: 10.1111/j.1600-0404.1997.tb00271.x.
- Background Di Geronimo G, Caccese AF, Caruso L, Soldati A, Passaretti U. Treatment of carpal tunnel syndrome with alpha-lipoic acid. Eur Rev Med Pharmacol Sci. 2009 Mar-Apr;13(2):133-9.
- Background Passiatore M, Perna A, De-Vitis R, Taccardo G. The Use of Alfa-Lipoic Acid-R (ALA-R) in Patients with Mild-Moderate Carpal Tunnel Syndrome: A Randomised Controlled Open Label Prospective Study. Malays Orthop J. 2020 Mar;14(1):1-6. doi: 10.5704/MOJ.2003.001.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pyridoxine | Unknown | 8 mg | Oral |
| Subject | Thiamine | Other / unclassified | 39 mg | Oral |
| Subject | alpha-lipoic acid | Small molecule | 300 mg | Oral |
| Subject | methylcobalamin | Small molecule | 500 ug | Oral |