Completed

Alpha Lipoic Acid and Vitamin B Complex for Carpal Tunnel Syndrome

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What is being tested

Bionerv

+ Placebo

Drug
Who is being recruted

Carpal Tunnel Syndrome+7

+ Nerve Compression Syndromes

+ Nervous System Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2 & 3
Interventional
Study Start: December 2023
See protocol details

Summary

Principal SponsorUniversiti Putra Malaysia
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2023

Actual date on which the first participant was enrolled.

This clinical trial aims to evaluate the effectiveness and safety of taking a combination of alpha lipoic acid and vitamin B for treating Carpal Tunnel Syndrome (CTS), a condition that causes pain and numbness in the hand and arm. The study is conducted with people experiencing CTS, and the goal is to see if this combination can help relieve symptoms and improve quality of life. Understanding whether this combination is beneficial could provide a new, potentially more effective treatment option for those affected by CTS. Participants in the study are randomly assigned to receive either the oral combination of alpha lipoic acid and vitamin B or a placebo, which is a substance with no therapeutic effect, for comparison. They take two tablets daily and are closely monitored throughout the study. Participants undergo physical exams, nerve conduction studies, and complete questionnaires about their symptoms, pain levels, and overall health at different points during the study to track any changes. The study also checks for any side effects of the treatment. Researchers ensure that participants are following the study requirements by making phone calls and sending reminders, and participants can still receive standard treatments like physiotherapy during the study.

Official TitleEvaluating 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.
NCT06940557
Principal SponsorUniversiti Putra Malaysia
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

70 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Carpal Tunnel SyndromeNerve Compression SyndromesNervous System DiseasesNeuromuscular DiseasesPeripheral Nervous System DiseasesCumulative Trauma DisordersSprains and StrainsWounds and InjuriesMononeuropathiesMedian Neuropathy

Criteria

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

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

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

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Hospital Sultan Abdul Aziz Shah

Serdang, MalaysiaOpen Hospital Sultan Abdul Aziz Shah in Google Maps
CompletedOne Study Center