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

NCT ID: NCT07312123

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-08

Study Completion Date

2027-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Carpal Tunnel Syndrome

Keywords

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carpal tunnel syndrome median nerve compression vitamin e peripheral nerve entrapment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Oral Antioxidant Supplement Group

Group Type EXPERIMENTAL

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

Intervention Type 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.

Control Group

Group Type ACTIVE_COMPARATOR

combination vitamin b1,b6 b12

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universiti Sains Malaysia

OTHER

Sponsor Role lead

BREGO Life Sciences Sdn Bhd

UNKNOWN

Sponsor Role collaborator

Responsible Party

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NURHAKIM BIN IBRAHIM

medical officer, master student in orthopedic

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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nurhakim bin ibrahim

Role: PRINCIPAL_INVESTIGATOR

Hospital Pakar Universiti Sains Malaysia

Locations

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Hospital Pakar Universiti Sains Malaysia

Kubang Kerian, Kelantan, Malaysia

Site Status RECRUITING

Countries

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Malaysia

Central Contacts

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Nurhakim Bin Ibrahim, MBBCH

Role: CONTACT

Phone: +60123170898

Email: [email protected]

ASSOCIATE PROFESSOR ABDUL NAWFAR BIN SADAGATULLAH

Role: CONTACT

Phone: +6097676378

Email: [email protected]

Facility Contacts

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NURHAKIM BIN IBRAHIM, MEDICAL OFFICER

Role: primary

ASSOCIATE PROFESSOR DR. ABDUL NAWFAR BIN SADAGATULLAH

Role: backup

Other Identifiers

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NMRR ID-25-01261-KS3

Identifier Type: OTHER

Identifier Source: secondary_id

USM/JEPeM/KK/25060535

Identifier Type: -

Identifier Source: org_study_id