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Recruiting NCT07312123

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

No phase Interventional Carpal Tunnel Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Alpha-Lipoic Acid, Vitamin E, and Vitamin B Complex, Combination Vitamin B1,B6,B12.
Who it may be relevant to
Registry conditions: Carpal Tunnel Syndrome. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Malaysia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official 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

Overview

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Change in Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) score [Time frame: Baseline to 12 and 24 weeks]
Secondary outcome measures (1)
  • Change in Pain Intensity Measured by Visual Analog Scale [Time frame: Baseline to 12 and 24 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Malaysia · 1 center
  • Hospital Pakar Universiti Sains Malaysia — Kubang Kerian

Identifiers

NCT: NCT07312123 · USM/JEPeM/KK/25060535 · NMRR ID-25-01261-KS3

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗