Restless Legs Syndrome
Conditions
Keywords
RLS
Brief summary
Investigating Tiobec® 400's efficacy in alleviating Restless Legs Syndrome symptoms sheds light on promising therapeutic avenues.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTAlpha-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
Sponsors
Uriach Consumer Healthcare
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure the subjective RLS symptoms of the participants through the IRLSSG rating scale (IRLS) | 6 months | This scale contains 10 items, rated from 0 to 4, according to the severity reported by the patient (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe.). The cumulative scores are categorized as mild (1-10), moderate (11-20), severe (21-30), and very severe (31-40). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anthropometric parameters of the patients. | 6 Months | Weight (kg). |
| Patients' body measurements | 6 Months | Body mass index (BMI) (kg/m²). |
| Measurements of patient anatomy | 6 Months | Total fat mass (kg). |
| Patients' body characteristics. | 6 Months | Visceral fat mass (kg). |
| Measurements of patient anatomy. | 6 Months | Muscle mass (kg). |
Countries
Spain
Outcome results
None listed