A Study to See Whether Taking a Mix of Vitamins Can Help Adults Recover Better After Surgery for Carpal Tunnel Syndrome

April 20, 2026 updated by: NURHAKIM BIN IBRAHIM, Hospital Universiti Sains Malaysia

Effect of Oral Alpha-Lipoic Acid, Vitamin E, and Vitamin B Combination on Symptoms and Function in Carpal Tunnel Syndrome Following Carpal Tunnel Surgery

Carpal Tunnel Syndrome (CTS) is a common condition that causes numbness, tingling, pain, and weakness in the hand due to compression of the median nerve at the wrist. It can affect daily activities, work performance, and quality of life. While surgery is effective in severe cases, many patients with mild to moderate CTS are initially treated with non-surgical options such as splinting and medications. However, the effectiveness of oral supplements for CTS remains uncertain.

This clinical study aims to evaluate whether an oral combination of alpha-lipoic acid, Vitamin E, and Vitamin B complex can safely reduce symptoms and improve hand function in patients with Carpal Tunnel Syndrome. These supplements are believed to have antioxidant, anti-inflammatory, and nerve-protective properties, which may help reduce nerve irritation and improve nerve recovery.

Participants in this study will be randomly assigned to receive either the oral supplement combination or a comparator treatment. The study is single-blinded, meaning participants will not know which treatment they are receiving. Symptoms such as pain, numbness, and hand function will be assessed over a defined follow-up period using clinical evaluation and standardized questionnaires.

The main hypothesis of this study is that patients receiving the oral combination of alpha-lipoic acid, Vitamin E, and Vitamin B will experience greater improvement in symptoms and functional outcomes compared to those who do not receive the combination, without significant side effects.

The results of this study may help determine whether this oral supplement combination can be used as an effective and safe conservative treatment option for patients with Carpal Tunnel Syndrome, potentially reducing the need for invasive procedures.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: ASSOCIATE PROFESSOR ABDUL NAWFAR BIN SADAGATULLAH
  • Phone Number: 6378 +6097676378
  • Email: nawfar@usm.my

Study Locations

  • Malaysia
    • Kelantan
      • Kubang Kerian, Kelantan, Malaysia, 16150
        • Recruiting
        • Hospital Pakar Universiti Sains Malaysia
        • Contact:
        • Contact:
          • ASSOCIATE PROFESSOR DR. ABDUL NAWFAR BIN SADAGATULLAH
          • Phone Number: +6097676378
          • Email: nawfar@usm.my
        • Principal Investigator:
          • nurhakim bin ibrahim, medical officer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age more than 18 years old
  • Subjects with symptoms and physical examination of CTS
  • Patients with CTS going for CT release

Exclusion Criteria:

  • Pregnant or breast-feeding women
  • Patients with history of trauma in the dominant hand

Study Plan

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

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group
Dietary supplement: Combination Vitamin B1,B6,B12
An oral Vitamin B complex supplement administered once daily for the study duration. This intervention serves as the active comparator for conservative treatment of Carpal Tunnel Syndrome.
Experimental: Oral Antioxidant Supplement Group
Dietary supplement: Alpha-Lipoic Acid, Vitamin E, and Vitamin B Complex
An oral dietary supplement containing a combination of alpha-lipoic acid, Vitamin E, and Vitamin B complex administered once daily for the study duration. The supplement is provided in capsule form and is intended to support nerve health through antioxidant and neuroprotective effects in patients with Carpal Tunnel Syndrome.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) score
Time Frame: Baseline to 12 and 24 weeks
The Boston Carpal Tunnel Questionnaire (BCTQ) is a patient-reported tool used to assess symptom severity and functional status in carpal tunnel syndrome. It consists of two subscales, with each item scored from 1 (no symptoms or difficulty) to 5 (most severe symptoms or inability). The final score is calculated as the mean of responses, ranging from 1 to 5. Lower scores indicate better outcomes, while higher scores indicate more severe symptoms and functional impairment.
Baseline to 12 and 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain Intensity Measured by Visual Analog Scale
Time Frame: Baseline to 12 and 24 weeks
The Visual Analog Scale (VAS) is used to assess pain intensity. It is a continuous scale ranging from 0 to 10, where 0 indicates no pain and 10 represents the worst imaginable pain. Patients are asked to rate their pain based on this scale. Higher scores indicate greater pain severity
Baseline to 12 and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universiti Sains Malaysia

Collaborators

BREGO Life Sciences Sdn Bhd

Investigators

  • Principal Investigator: nurhakim bin ibrahim, Hospital Pakar Universiti Sains Malaysia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 8, 2025

Primary Completion (Estimated)

December 8, 2026

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

December 16, 2025

First Submitted That Met QC Criteria

December 16, 2025

First Posted (Actual)

December 31, 2025

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USM/JEPeM/KK/25060535
  • NMRR ID-25-01261-KS3 (Other Identifier: National Medical Research Register by National Institutes of Health , Ministry of Health Malaysia)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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