Alpha-lipoic Acid Combined With B Vitamins Shows Promise for Treating Restless Legs Syndrome

NCT ID: NCT06324760

Last Updated: 2024-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-04

Study Completion Date

2021-06-02

Brief Summary

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Investigating Tiobec® 400's efficacy in alleviating Restless Legs Syndrome symptoms sheds light on promising therapeutic avenues.

Detailed Description

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Restless legs syndrome, also known as Willis-Ekbom disease, is a neurological disorder characterised by uncomfortable sensations in the legs and an urge to move them. In Spain, its prevalence range is estimated to be between 11.6% - 19.5% in adults, but it is difficult to know due to underdiagnosis. Alpha-lipoic acid (ALA) and B vitamins have emerged as potential treatments due to their roles in reducing oxidative stress and associated vitamin deficiencies. The Tiobec® 400 (T400) supplement combines ALA, B vitamins, E, and C, and its efficacy and safety in alleviating RLS symptoms, along with its impact on anthropometric measures, are under investigation. This study aims to explore therapeutic options for managing RLS, with promising results.

Conditions

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Restless Legs Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Alpha-lipoic acid combined with B vitamins

The investigational product utilized in this research, Tiobec® 400 is a dietary supplement enriched with ALA, B vitamins, and vitamins E and C. T400 is designed to mitigate oxidative stress and support the optimal functioning of the nervous system

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Participants must be a minimum of 18 years of age.
* They must have a primary diagnosis of RLS without prior therapeutic interventions for the ailment.
* They need to provide explicit consent via an informed consent document.

Exclusion Criteria

* Patients diagnosed with pathologies other than RLS that affect sleep quality.
* Those with persistent renal diseases or any other chronic, severe medical condition.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Uriach Consumer Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Javier Albares, Doctor

Role: PRINCIPAL_INVESTIGATOR

Centro Medico Teknon

Locations

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Medical Center Teknon

Barcelona, , Spain

Site Status

Countries

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Spain

Other Identifiers

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LIPOICSPI2018

Identifier Type: -

Identifier Source: org_study_id

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