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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06324760
Other study ID # LIPOICSPI2018
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 4, 2020
Est. completion date June 2, 2021

Study information

Verified date March 2024
Source Uriach Consumer Healthcare
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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 TiobecĀ® 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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date June 2, 2021
Est. primary completion date June 2, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
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

Locations

Country Name City State
Spain Medical Center Teknon Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Uriach Consumer Healthcare

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary Anthropometric parameters of the patients. Weight (kg). 6 Months
Secondary Patients' body measurements Body mass index (BMI) (kg/mĀ²). 6 Months
Secondary Measurements of patient anatomy Total fat mass (kg). 6 Months
Secondary Patients' body characteristics. Visceral fat mass (kg). 6 Months
Secondary Measurements of patient anatomy. Muscle mass (kg). 6 Months
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