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

NCT07312123 | Recruiting

• 2 other identifiers: USM/JEPeM/KK/25060535NMRR ID-25-01261-KS3
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Carpal Tunnel Syndrome

Keywords

carpal tunnel syndrome; median nerve compression; vitamin e; peripheral nerve entrapment

Outcome Measures

Primary Outcomes (1)

• Change in Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) score

  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 Outcomes (1)

• Change in Pain Intensity Measured by Visual Analog Scale

  Baseline to 12 and 24 weeks

Study Arms (2)

Oral Antioxidant Supplement Group

EXPERIMENTAL

Dietary Supplement: Alpha-Lipoic Acid, Vitamin E, and Vitamin B Complex

Control Group

ACTIVE COMPARATOR

Dietary Supplement: Combination Vitamin B1,B6,B12

Interventions

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.

Oral Antioxidant Supplement Group

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.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Universiti Sains Malaysia: lead
• BREGO Life Sciences Sdn Bhd: collaborator

Study Sites (1)

Hospital Pakar Universiti Sains Malaysia

Kubang Kerian, Kelantan, 16150, Malaysia

RECRUITING

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Thioctic Acid; Vitamin E; Vitamin B Complex

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Carboxylic Acids; Organic Chemicals; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Vitamins; Micronutrients; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• nurhakim bin ibrahim

  Hospital Pakar Universiti Sains Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nurhakim Bin Ibrahim, MBBCH

CONTACT

+60123170898; nurhakimibrahim@gmail.com

ASSOCIATE PROFESSOR ABDUL NAWFAR BIN SADAGATULLAH

CONTACT

+6097676378; nawfar@usm.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Officer, Master Student in Orthopedic

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: December 31, 2025
• Study Start: December 8, 2025
• Primary Completion (Estimated): December 8, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

MY (1)