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NCT Number: NCT07312123

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Pakar Universiti Sains Malaysia

Kubang Kerian, Kelantan, 16150, Malaysia

Location status: Recruiting

Location contact

ASSOCIATE PROFESSOR DR. ABDUL NAWFAR BIN SADAGATULLAH

CONTACT

[email protected]

+6097676378

NURHAKIM BIN IBRAHIM, MEDICAL OFFICER

CONTACT

[email protected]

+60123170898

nurhakim bin ibrahim, medical officer

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alpha-Lipoic Acid, Vitamin E, and Vitamin B Complex

Dietary Supplement

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.

Combination Vitamin B1,B6,B12

Dietary Supplement

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

ASSOCIATE PROFESSOR ABDUL NAWFAR BIN SADAGATULLAH

CONTACT

[email protected]

+6097676378 ext. 6378

Nurhakim Bin Ibrahim, MBBCH

CONTACT

[email protected]

+60123170898

Sponsors and collaborators

Lead sponsor

Hospital Universiti Sains Malaysia

Other

Collaborators

  • BREGO Life Sciences Sdn Bhd

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Dec 31, 2025
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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