Alpha-lipoic Acid Combined With B Vitamins Shows Promise for Treating Restless Legs Syndrome
Usefulness of Alpha-lipoic Acid Combined With B Vitamins for the Treatment of Restless Legs Syndrome
1 other identifier
observational
20
1 country
1
Brief Summary
Investigating Tiobec® 400's efficacy in alleviating Restless Legs Syndrome symptoms sheds light on promising therapeutic avenues.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 2, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 2, 2021
CompletedFirst Submitted
Initial submission to the registry
March 12, 2024
CompletedFirst Posted
Study publicly available on registry
March 22, 2024
CompletedMarch 22, 2024
March 1, 2024
1.2 years
March 12, 2024
March 21, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Anthropometric parameters of the patients.
6 Months
Patients' body measurements
6 Months
Measurements of patient anatomy
6 Months
Patients' body characteristics.
6 Months
Measurements of patient anatomy.
6 Months
Interventions
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
Eligibility Criteria
The data will be collected from patients who meet the selection criteria.
You may qualify if:
- 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.
You may not qualify if:
- Patients diagnosed with pathologies other than RLS that affect sleep quality.
- Those with persistent renal diseases or any other chronic, severe medical condition.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical Center Teknon
Barcelona, 08017, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Javier Albares, Doctor
Centro Medico Teknon
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2024
First Posted
March 22, 2024
Study Start
March 4, 2020
Primary Completion
June 2, 2021
Study Completion
June 2, 2021
Last Updated
March 22, 2024
Record last verified: 2024-03