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临床试验/NCT07312123
NCT07312123招募中不适用

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

Hospital Universiti Sains Malaysia2 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2025年12月8日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
84
试验地点
2
主要终点
Change in Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) score

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Change in Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) score

时间窗: baseline to 12 and 24 weeks

次要结局

  • Change in Pain Intensity Measured by Visual Analog Scale(baseline to 12 and 24 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

NURHAKIM BIN IBRAHIM

medical officer, master student in orthopedic

Hospital Universiti Sains Malaysia

研究点 (2)

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