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

Evaluating The Efficacy And Tolerability Of The Oral Combination Of Alpha Lipoic Acid And Vitamin B Complex Preparation In Carpal Tunnel Syndrome : a Single-center, Randomized, Double-blind, Placebo-controlled Trial.

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.

Study Overview

• Status: Completed
• Conditions: Carpal Tunnel Syndrome (CTS)
• Intervention / Treatment: Drug: Bionerv; Drug: Placebo

Detailed Description

The patients were randomized to receive oral combination of alpha lipoic acid and vitamin B (alpha lipoic acid; 300mg, methylcobalamin; 500mcg, vitamin B1; 39mg and vitamin B6; 8mg), 2 tablets once daily or placebo drug (maltodextrin, microcrystalline cellulose, tricalcium phosphate, silicon gioxide, magnesium stearate) 2 tablets once daily. Randomization sequence was done by using an online random number generator program using a mixed block randomization technique at a ratio of 1:1. In cases of serious adverse event, unblinding process was incorporated where the identity of the drug was revealed to manage the subject's condition. This was done by intruding the emergency code key by the researcher. All patients provided a written consent for the study.

During visit 1, a thorough history and physical examination were done, and demographic data was collected. Afterward, the patients were required to answer three sets of self-administered questionnaires: Boston Carpal Tunnel Questionnaire (BCTQ), Visual analogue score (VAS) and SF-36. The BCTQ is a specific questionnaire for assessing CTS that consists of two distinct scales, the Symptom Specific Scale (SSS) which has 11 items and the Functional Status Scale (FSS) containing 8 items. Each scale generates a final score ranging from 1 to 5, with a higher score indicating greater disability and poor symptoms control. BCTQ is a reliable questionnaire to assess CTS owing to its high cross-cultural adaptation and multilingual validity and reliability. The VAS is a visual scale with 0 scored as "no pain" and 10 as "worst pain imaginable" and serves as an excellent tool for pain score with excellent validity and reproducibility. The SF-36 is a quality-of-life questionnaire that comprises of 36 questions covering eight domains of health which are; Physical Functioning (PF), Role Limitations due to Physical Health, Role Limitations (RL) due to Emotional Problems (RE), energy/fatigue, emotional well-being, social functioning, pain, and general health (GH) where a higher score indicates a better outcome . After the administration of these questionnaires, they will be subjected for a nerve conduction study (NCS) to determine the severity of CTS. The NCS were performed by the same trained personnel to ensure consistency and accuracy.

The patients were reassessed at Visit 2 (3 months post-treatment) and Visit 3 (6 months post-treatment). During each visit, they underwent physical examination, NCS, and were required to complete the three sets of questionnaires (BCTQ, VAS, and SF-36). They were also required to fill in the form regarding the side effects of the treatments. The investigators made a phone call and sent reminder message at the 6th and 18th week to ensure compliance, medication adequacy and follow up review. During the study, patients were allowed to undergo the standard of care treatment at our center such as physiotherapy.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Malaysia
  • Selangor
    • Serdang, Selangor, Malaysia, 43000
      • Hospital Sultan Abdul Aziz Shah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treament; alpha lipoic acid; 300mg, methylcobalamin; 500mcg, vitamin B1; 39mg and vitamin B6; 8mg 2 tablets once daily	Drug: Bionerv; alpha lipoic acid; 300mg, methylcobalamin; 500mcg, vitamin B1; 39mg and vitamin B6; 8mg, 2 tablets once daily; Other Names: Group A
Placebo Comparator: Placebo; maltodextrin, microcrystalline cellulose, tricalcium phosphate, silicon gioxide, magnesium stearate 2 tablets once daily	Drug: Placebo; maltodextrin, microcrystalline cellulose, tricalcium phosphate, silicon gioxide, magnesium stearate 2 tablets once daily; Other Names: Group B

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvements in symptoms using the Boston Carpal Tunnel Questionnaire (BCTQ)	The BCTQ is a specific self administered questionnaire for assessing CTS that consists of two distinct scales, the Symptom Specific Scale (SSS) which has 11 items and the Functional Status Scale (FSS) containing 8 items. Each scale generates a final score ranging from 1 to 5, with a higher score indicating greater disability and poor symptoms control. BCTQ is a reliable questionnaire to assess CTS owing to its high cross-cultural adaptation and multilingual validity and reliability	Enrolment (Visit 0) to Visit 1 (3 months) and to Visit 2 (6 months)
Improvements in symptoms using the visual analog score (VAS)	The VAS is a visual scale with 0 scored as "no pain" and 10 as "worst pain imaginable" and serves as an excellent tool for pain scoring with excellent validity and reproducibility	Enrolment (Visit 0) to Visit 1 (3 months) and to Visit 2 (6 months)
Improvements in quality of life using the SF-36 questionnaire	The SF-36 is a quality-of-life is a self administered questionnaire that comprises 36 questions covering eight domains of health: physical functioning (PF), role limitations due to physical health, role limitations (RL) due to emotional problems (RE), energy/fatigue, emotional well-being, social functioning, pain, and general health (GH), where a higher score indicates a better outcome.	Enrolment (Visit 0) to Visit 1 (3 months) and to Visit 2 (6 months)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Side effects of the treatment and tolerability	The tolerability in this study is based on patient reporting side-effects that developed after taking the medications using a self-administered reporting form. There are no blood or radiological investigation involved to confirm its association with the symptoms.	Enrolment (Visit 0) to Visit 1 (3 months) and to Visit 2 (6 months)

Collaborators and Investigators

• Sponsor: Universiti Putra Malaysia
• Collaborators: BREGO Life Sciences Sdn Bhd
• Investigators: Principal Investigator: ANNA MISYAIL ABDUL RASHID, NEUROLOGIST, UPM

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Actual): September 30, 2024
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: April 7, 2025
• First Submitted That Met QC Criteria: April 15, 2025
• First Posted (Actual): April 23, 2025

Study Record Updates

• Last Update Posted (Actual): April 23, 2025
• Last Update Submitted That Met QC Criteria: April 15, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: VAS; Vitamin B; SF-36; NCS; Alpha Lipoic Acid; CTS; BCTQ
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Pathologic Processes; Neuromuscular Diseases; Peripheral Nervous System Diseases; Disease; Median Neuropathy; Mononeuropathies; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome
• Other Study ID Numbers: JKEUPM-2022-984

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The individual participant data (IPD) from this study will not be shared to ensure patient confidentiality, as participants did not provide explicit consent for data sharing. Additionally, ethical guidelines, regulatory constraints, and concerns about potential data misuse further limit the feasibility of sharing IPD.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No