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.
Age more than 18 years old
Subjects with symptoms and physical examination of CTS
Patients with CTS going for CT release
Pregnant or breast-feeding women
Patients with history of trauma in the dominant hand
Parallel
Alpha-Lipoic Acid, Vitamin E, and Vitamin B Complex
Dietary supplementAn 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 supplementAn 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.
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.
Change in Pain Intensity Measured by Visual Analog Scale
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
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Hospital Universiti Sains Malaysia
Lead sponsor
BREGO Life Sciences Sdn Bhd
Collaborator
