ISRCTN74944427Completed未知
Study of the efficacy of a food supplement based on pomegranate, vitamin C and B vitamins, in adults with short-term fatigue: monocentric, controlled, randomized, parallel-group, double-blind clinical study.
ESSERRE Pharma S.r.l.0 sites58 target enrollmentStarted: October 31, 2022Last updated:
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 58
Study Overview
Brief Summary
2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37447210/ (added 02/08/2023)
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Healthy subjects, according to what was determined by the clinical history and by the information provided during the recruitment;
- •2. Aged between 18 and 75 years;
- •3. Who has been in a condition of medium or moderate fatigue and fatigue for at least one month;
- •4. With FSS score < 5;
- •5. Able to understand and sign the informed consent.
Exclusion Criteria
- •1. Have been in fatigue for more than six months;
- •2. With an FSS questionnaire score> 5;
- •3. In conditions of pregnancy or breastfeeding;
- •4. Cognitive disorders that can hinder the response to questionnaires;
- •5. History of allergy to the ingredients contained in the treatments under study (dietary supplement and placebo);
- •6. Chronic pathologies or comorbidities from which the condition of fatigue could derive;
- •7. Malabsorption;
- •8. History of drug, drug or alcohol addiction or abuse;
- •9. Eating disorders;
- •10. Heart disease;
- •11. Chronic biliary and pancreatic liver diseases;
- •12. Neoplastic pathologies;
- •13. Genetic-metabolic diseases;
- •14. Diabetes;
- •15. Rheumatological diseases;
- •16. Chronic hematological diseases.
Investigators
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