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Search / Trial NCT03186027

Coenzyme Q10 Plus NADH Supplementation in Chronic Fatigue Syndrome/Myalgic Encephalomyelitis

Launched by HOSPITAL UNIVERSITARI VALL D'HEBRON RESEARCH INSTITUTE · Jun 11, 2017

Trial Information

Current as of April 25, 2025

Completed

Keywords

Chronic Fatigue Sleep Problems Autonomic Dysfunction Health Related Quality Of Life Coenzyme Q10 Nadh

ClinConnect Summary

Chronic Fatigue Syndrome, as known as Myalgic Encephalomyelitis (CFS/ME) is a complex and extremely debilitating chronic condition, with no known cause, no established diagnostic tests, and no universal effective therapy. Its symptoms are mainly unexplained disabling fatigue that lasts for six months or more and that does not improve with rest, worsing with physical and mental activity. It is associated with other concomitant symptoms including muscle pain, post-exertional malaise lasting more than 24h, unrefreshing sleep, autonomic dysfunction and cognitive problems worsing quality of life...

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • 1. Patients female between 18 and 65 years old.
  • 2. Body Mass Index (BMI) ≤ 30 mg/m²
  • 3. Subjects who met the 1994 Centers for Disease Control and Prevention/Fukuda definition and 2003 Canadian diagnostic criteria for CFS/ME.
  • 4. Patients must be able to participate, understand and complete questionnaires in Spanish language.
  • 5. Patients who give a signed informed consent before initiating the study.
  • Exclusion Criteria:
  • 1. Patients who do not fulfilled the 1994 Centers for Disease Control and Prevention/Fukuda definition and 2003 Canadian criteria for CFS/ME.
  • 2. Patients who are participating in another clinical trial of the same or different nature in the last 30 days prior to inclusion.
  • 3. Any participants who, in the opinion of the principal investigator, may not be able to follow instructions or make a good treatment compliance.
  • 4. Subjects that don't give signed informed consent to participate in the study.
  • 5. Participants who are receiving any drug or banned substances and is expected that withdrawal of some medications/products not allowed in the study involves a significant problem.
  • 6. Participants who are pregnant and/or breastfeeding,
  • 7. Participants with autoimmune disorder, cancer, endocrine and metabolic disorders, rheumatic conditions, multiple sclerosis, psychosis, major depression, cardiovascular disease, hematological conditions, use of oral anticoagulants, smokers or had a history of substance abuse.

Trial Officials

Jose Alegre, MD; PhD

Principal Investigator

Vall d'Hebron University Hospital (CFS/ME Clinical Unit)

About Hospital Universitari Vall D'hebron Research Institute

The Hospital Universitari Vall d'Hebron Research Institute (VHIR) is a leading biomedical research center affiliated with Vall d'Hebron University Hospital in Barcelona, Spain. Committed to advancing healthcare through innovative research, VHIR focuses on translating scientific discoveries into clinical applications, enhancing patient care and outcomes. The institute fosters collaboration among multidisciplinary teams of researchers, clinicians, and industry partners, emphasizing excellence in translational medicine, clinical trials, and public health initiatives. With a strong emphasis on ethical standards and patient safety, VHIR is dedicated to contributing to the global body of knowledge in various medical fields.

Locations

Barcelona, , Spain

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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