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Effectiveness and Safety of Thread Embedding Acupuncture for Drug Resistant Epilepsy

Acupuncture Therapy Clinical Trial

Official title:
Effectiveness and Safety of Thread Embedding Acupuncture for Drug Resistant Epilepsy: a Randomized Clinical Trial

Clinical Trial Summary

Epilepsy is one of the most common neurological diseases all over the world. Currently, about 70 million people have epilepsy worldwide. In particular, more than 30% of epilepsy patients still have seizures even though they are treated with appropriate anti-epileptic drugs (AEDs). This number has remained unchanged even after more than 20 years with many new anti-epileptic drugs being introduced. According to International League Against Epilepsy (ILAE), drug-resistant epilepsy is defined when a patient does not achieve seizure-free the seizure with two optimal antiepileptic drugs. This clinical trial is designed to evaluate the effectiveness and safety of thread-embedding acupuncture (TEA) as palliative treatment of drug resistant epilepsy.

Clinical Trial Description

The objectives of this clinical trial are twofold: the effectiveness of TEA is assessed by comparing the changes in the seizure control and quality of life at 5 months between 2 groups: the TEA + baseline AEDs group and the sham-TEA (STEA) + baseline AEDs group. Adverse events (AEs) that occur during the study will be investigated to evaluate the safety of TEA. This study is investigated by the following hypotheses: - TEA can increase the probability of becoming seizure free. - TEA can reduce the frequency and duration of seizures. - TEA can improve quality of life. - TEA is associated with adverse effects. This clinical trial will be performed as a 2-arm parallel design, randomized, controlled, assessor-blinded, clinical trial. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04673071
Study type Interventional
Source University of Medicine and Pharmacy at Ho Chi Minh City
Contact Dan V Nguyen, MD
Phone +84983731326
Email nguyenvandan@ump.edu.vn
Status Recruiting
Phase N/A
Start date November 17, 2020
Completion date November 2022
View Details
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