Status:
COMPLETED
Efficacy And Tolerability Of Alpha Lipoic Acid And Vitamin B Preparation In Carpal Tunnel Syndrome
Lead Sponsor:
Universiti Putra Malaysia
Collaborating Sponsors:
BREGO Life Sciences Sdn Bhd
Conditions:
Carpal Tunnel Syndrome (CTS)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The goal of this clinical trial is to assess the effectiveness and safety of an oral combination of alpha lipoic acid (ALA) and vitamin B complex in treating mild to moderate carpal tunnel syndrome (C...
Detailed Description
The patients were randomized to receive oral combination of alpha lipoic acid and vitamin B (alpha lipoic acid; 300mg, methylcobalamin; 500mcg, vitamin B1; 39mg and vitamin B6; 8mg), 2 tablets once da...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2024
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06940557
Start Date
December 1 2023
End Date
September 30 2024
Last Update
April 23 2025
Active Locations (1)
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1
Hospital Sultan Abdul Aziz Shah
Serdang, Selangor, Malaysia, 43000