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Clinical Trial to Assess the Improvement of Fatigue, Sleep Problems, Anxiety / Depression, Neurovegetatives Alterations and Quality of Life After the Administration of ImmunoVita® in Chronic Fatigue Syndrome Patients

NCT04301609 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2023-03-15

No results posted yet for this study

Summary

Chronic Fatigue Syndrome, also known as Myalgic Encephalomyelitis (CFS / MS) is a medical entity characterized mainly by debilitating and prolonged fatigue lasting more than 6 months, post-exertion fatigue (physical and / or mental), non-sleep restorative, cognitive impairment and orthostatic intolerance with prolonged recovery that is not relieved by rest. Currently, the etiopathogenic mechanisms of the disease are not known, although mitochondrial dysfunction with bioenergetic immuno-metabolism alterations, oxidative stress, and immuno-inflammatory response stands out. At present, there is no diagnostic test, nor effective treatment in the disease. ImmunoVita, is a food supplement composed of the latest yeast beta-glucans, in addition to vitamin D3, vitamin B6 and zinc, which could contribute to the normal functioning of the immune system and the inflammatory response.

Conditions

  • Chronic Fatigue Syndrome
  • Myalgic Encephalomyelitis

Interventions

DIETARY_SUPPLEMENT

Active

Take 4 capsules daily (2 capsules on an empty stomach + 2 capsules 30 minutes before dinner).

DIETARY_SUPPLEMENT

Placebo

Take 4 capsules daily (2 capsules on an empty stomach + 2 capsules 30 minutes before dinner).

Sponsors & Collaborators

  • Hospital Vall d'Hebron

    collaborator OTHER

  • Vitae Health Innovation

    lead INDUSTRY

Principal Investigators

  • José Alegre, PhD · Hospital Vall d´Hebron

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-10
Primary Completion
2022-12-30
Completion
2023-01-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04301609 on ClinicalTrials.gov