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
Condition: Chronic Fatigue Syndrome; Myalgic Encephalomyelitis
MeSH terms: Encephalomyelitis; Fatigue Syndrome, Chronic; Syndrome; Fatigue
Study type: Interventional

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.
    

Detailed description: 
      In patients with CFS / ME, neuroimmune, gastrointestinal, autonomic and cardiovascular
      alterations have been observed, among others. CFS / ME is characterized by disabling chronic
      fatigue, non-restorative sleep, severe intolerance to physical exercise, neurocognitive
      dysfunction with changes in concentration and immediate memory and neurovegetative symptoms
      in the form of dizziness, syncopes and alterations in bowel and bladder rhythm . Within the
      etiopathogenic hypotheses of the disease, they are involved if patients treated with
      ImmunoVita® could significantly reduce the scores on the scale of the impact of fatigue,
      sleep problems, neurovegetative dysfunction, anxiety / depression, and improve the quality of
      life compared to the placebo group.

      Based on the different etiopathogenic hypotheses of the syndrome, various mechanisms would be
      involved, which could modulate them, the ImmunoVita food complex.

        1. Do patients with CFS / ME have high scores on the fatigue impact scale, hospital
           anxiety-depression scale and Pittsburg sleep quality questionnaire?

        2. Do patients with CFS / ME have high scores in the autonomic dysfunction symptomatology
           scale?

        3. Do patients with CFS / ME have low scores in the SF-36 quality of life questionnaire?

        4. Do CFS / MS patients treated with ImmunoVita significantly reduce the scores on the
           scales of fatigue, anxiety / depression and autonomic dysfunction?

        5. Will patients with CFS / ME treated with ImmunoVita significantly increase the scores on
           the SF-36 quality of life questionnaire?

      GOALS

      Main goal

      The objective of this study is to assess the efficacy of active ImmunoVita® in patients with
      CFS / MS vs. placebo in the perception of fatigue, evaluated through the scale of perception
      of fatigue (FIS-40).

      Secondary goals:

        1. Evaluate the efficacy of active ImmunoVita® in patients with CFS / MS vs. placebo in the
           improvement of sleep dysfunction, through the Pittsburg questionnaire.

        2. Analyze the efficacy of active ImmunoVita®, in patients with CFS / ME vs. placebo in the
           improvement of anxiety-depressive symptomatology, through the hospital
           anxiety-depression scale (HAD).

        3. Evaluate the efficacy of active ImmunoVita®, in patients with CFS / ME vs. placebo in
           the improvement of the quality of life, through the SF-36 questionnaire.
    

Intervention name(s): Active; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Take 4 capsules daily (2 capsules on an empty stomach + 2 capsules 30 minutes before dinner).; Take 4 capsules daily (2 capsules on an empty stomach + 2 capsules 30 minutes before dinner).
Other intervention name(s): ImmunoVita®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Fatigue Syndrome; Encephalomyelitis; Fibromyalgia