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

Официальное название

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

Обзор

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.

Вмешательства

• Пищевая добавка 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.
• Пищевая добавка 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.

Первичные конечные точки

• Change in Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) score [Срок оценки: Baseline to 12 and 24 weeks]

Вторичные конечные точки (1)

• Change in Pain Intensity Measured by Visual Analog Scale [Срок оценки: Baseline to 12 and 24 weeks]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Малайзия · 1 центр

• Hospital Pakar Universiti Sains Malaysia — Kubang Kerian

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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