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

NCT06940557 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-04-23

No results posted yet for this study

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)

Interventions

DRUG

Bionerv

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

DRUG

Placebo

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

Sponsors & Collaborators

  • BREGO Life Sciences Sdn Bhd

    collaborator UNKNOWN

  • Universiti Putra Malaysia

    lead OTHER

Principal Investigators

  • ANNA MISYAIL ABDUL RASHID, NEUROLOGIST · UPM

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2024-09-30
Completion
2024-09-30

Countries

  • Malaysia

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06940557 on ClinicalTrials.gov