Status:
COMPLETED
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
Lead Sponsor:
Vitae Health Innovation
Collaborating Sponsors:
Hospital Vall d'Hebron
Conditions:
Chronic Fatigue Syndrome
Myalgic Encephalomyelitis
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 fa...
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-restora...
Eligibility Criteria
Inclusion
- Adult patients of both sexes, between 18-65 years.
- Patients with a BMI ≤ 25.
- Patients diagnosed with Chronic Fatigue Syndrome according to diagnostic criteria of 1994 CDC / Fukuda and 2003 Canadian criteria from the University of Central Sensitization Syndrome (Vall d'Hebron University Hospital, Barcelona).
- Patients who freely grant written consent.
Exclusion
- Patients who are participating in another clinical trial of the same or different nature in the last 30 days prior to inclusion.
- Any subject that, in the opinion of the investigator, is not able to follow the instructions or make a good completion of the treatment.
- Subjects who do not grant written informed consent to participate in the study.
- Patients who are receiving any of the prohibited drugs or products and that the withdrawal of the drugs / products not allowed in the study is expected to pose a relevant problem.
- Pregnant women and / or during breastfeeding periods.
- Patients under treatment with oral anticoagulants.
- Patient with any type of immunosuppression.
Key Trial Info
Start Date :
November 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2023
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT04301609
Start Date
November 10 2021
End Date
January 31 2023
Last Update
March 15 2023
Active Locations (1)
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1
Hospital Vall d'Hebron
Barcelona, Spain, 08035