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 enrollmentOctober 31, 2022

Overview

2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37447210/ (added 02/08/2023)

Registry

who.int

Start Date

October 31, 2022

End Date

April 15, 2023

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

ESSERRE Pharma S.r.l.

•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.

•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;