Alpha Lipoic Acid and Vitamin B Complex for Carpal Tunnel Syndrome
Bionerv
+ Placebo
Carpal Tunnel Syndrome+7
+ Nerve Compression Syndromes
+ Nervous System Diseases
Treatment Study
Summary
Study start date: December 1, 2023
Actual date on which the first participant was enrolled.This clinical trial aims to evaluate the effectiveness and safety of taking a combination of alpha lipoic acid and vitamin B for treating Carpal Tunnel Syndrome (CTS), a condition that causes pain and numbness in the hand and arm. The study is conducted with people experiencing CTS, and the goal is to see if this combination can help relieve symptoms and improve quality of life. Understanding whether this combination is beneficial could provide a new, potentially more effective treatment option for those affected by CTS. Participants in the study are randomly assigned to receive either the oral combination of alpha lipoic acid and vitamin B or a placebo, which is a substance with no therapeutic effect, for comparison. They take two tablets daily and are closely monitored throughout the study. Participants undergo physical exams, nerve conduction studies, and complete questionnaires about their symptoms, pain levels, and overall health at different points during the study to track any changes. The study also checks for any side effects of the treatment. Researchers ensure that participants are following the study requirements by making phone calls and sending reminders, and participants can still receive standard treatments like physiotherapy during the study.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.70 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * all patients with numbness and tingling sensation at the first finger until the radial site of the 4th finger * and/or fulfil the electrodiagnostic criteria of mild to moderate CTS, based on the Padua Scale as defined below: * Mild: abnormal digit/wrist Sensory Nerve Conduction Velocity (CV) and normal Distal Motor Latency (DML) * Moderate: abnormal digit/wrist Sensory Nerve Conduction Velocity (SNCV) and abnormal Distal Motor Latency (DML). Exclusion Criteria: * pregnant or breastfeeding women * patients with symptoms of CTS but have normal NCS * patients taking traditional or complementary medication for CTS * patients with electrodiagnostic criteria of severe or extreme CTS as defined in the Padua scale: * Severe: Absence of sensory response (SNAP) and abnormal Distal Motor Latency (DML). * Extreme: Absence of motor (CMAP) and sensory responses (SNAP).
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
Active ComparatorGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location