Efficacy And Tolerability Of Alpha Lipoic Acid And Vitamin B Preparation In Carpal Tunnel Syndrome

NCT06940557 | Completed Phase 2

• 1 other identifier: JKEUPM-2022-984
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Carpal Tunnel Syndrome (CTS)

Keywords

Vitamin B; Alpha Lipoic Acid; CTS; NCS; BCTQ; SF-36; VAS

Outcome Measures

Primary Outcomes (1)

• Improvement on Nerve Conduction Study

  Electrodiagnostic improvement of the median nerve on Nerve Conduction Study (NCS)

  Enrolment (Visit 0) to Visit 1 (3 months) and to Visit 2 (6 months)

Secondary Outcomes (3)

• Improvements in symptoms using the Boston Carpal Tunnel Questionnaire (BCTQ)

  Enrolment (Visit 0) to Visit 1 (3 months) and to Visit 2 (6 months)

• Improvements in symptoms using the visual analog score (VAS)

  Enrolment (Visit 0) to Visit 1 (3 months) and to Visit 2 (6 months)

• Improvements in quality of life using the SF-36 questionnaire

  Enrolment (Visit 0) to Visit 1 (3 months) and to Visit 2 (6 months)

Other Outcomes (1)

• Side effects of the treatment and tolerability

  Enrolment (Visit 0) to Visit 1 (3 months) and to Visit 2 (6 months)

Study Arms (2)

Treament

ACTIVE COMPARATOR

alpha lipoic acid; 300mg, methylcobalamin; 500mcg, vitamin B1; 39mg and vitamin B6; 8mg 2 tablets once daily

Drug: Bionerv

Placebo

PLACEBO COMPARATOR

maltodextrin, microcrystalline cellulose, tricalcium phosphate, silicon gioxide, magnesium stearate 2 tablets once daily

Drug: Placebo

Interventions

Bionerv DRUG

alpha lipoic acid; 300mg, methylcobalamin; 500mcg, vitamin B1; 39mg and vitamin B6; 8mg, 2 tablets once daily

Also known as: Group A

Treament

Placebo DRUG

maltodextrin, microcrystalline cellulose, tricalcium phosphate, silicon gioxide, magnesium stearate 2 tablets once daily

Also known as: Group B

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• all patients with numbness and tingling sensation at the first finger until the radial site of the 4th finger
• and/or fulfil the electrodiagnostic criteria of mild to moderate CTS, based on the Padua Scale as defined below:
• Mild: abnormal digit/wrist Sensory Nerve Conduction Velocity (CV) and normal Distal Motor Latency (DML)
• Moderate: abnormal digit/wrist Sensory Nerve Conduction Velocity (SNCV) and abnormal Distal Motor Latency (DML).

You may not qualify if:

• pregnant or breastfeeding women
• patients with symptoms of CTS but have normal NCS
• patients taking traditional or complementary medication for CTS
• patients with electrodiagnostic criteria of severe or extreme CTS as defined in the Padua scale:
• Severe: Absence of sensory response (SNAP) and abnormal Distal Motor Latency (DML).
• Extreme: Absence of motor (CMAP) and sensory responses (SNAP).

Sponsors & Collaborators

• Universiti Putra Malaysia: lead
• BREGO Life Sciences Sdn Bhd: collaborator

Study Sites (1)

Hospital Sultan Abdul Aziz Shah

Serdang, Selangor, 43000, Malaysia

Location

Related Publications (3)

• 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.

  PMID: 9325471 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.

  PMID: 19499849 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.

  PMID: 32296475 BACKGROUND

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• ANNA MISYAIL ABDUL RASHID, NEUROLOGIST

  UPM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double blind trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr,

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 23, 2025
• Study Start: December 1, 2023
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: April 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)