Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Investigating Tiobec® 400's efficacy in alleviating Restless Legs Syndrome symptoms sheds light on promising therapeutic avenues.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alpha-lipoic acid combined with B vitamins | Dietary Supplement | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Measure the subjective RLS symptoms of the participants through the IRLSSG rating scale (IRLS) | 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). | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Anthropometric parameters of the patients. | Weight (kg). | 6 Months |
| Patients' body measurements | Body mass index (BMI) (kg/m²). | 6 Months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
The data will be collected from patients who meet the selection criteria.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Javier Albares, Doctor | Centro Medico Teknon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Center Teknon | Barcelona | 08017 | Spain |
Not provided
| ID | Term |
|---|---|
| D012148 | Restless Legs Syndrome |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D014803 | Vitamin B Complex |
| ID | Term |
|---|---|
| D014815 | Vitamins |
| D018977 | Micronutrients |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
Not provided
Not provided
Not provided
Not provided
Not provided
| Measurements of patient anatomy | Total fat mass (kg). | 6 Months |
| Patients' body characteristics. | Visceral fat mass (kg). | 6 Months |
| Measurements of patient anatomy. | Muscle mass (kg). | 6 Months |
| D020447 |
| Parasomnias |
| D001523 | Mental Disorders |
| D020164 |
| Chemical Actions and Uses |