It has been demonstrated that consequences of malnutrition affect a situation of risk and have negative effects on the evolution of chronic obstructive pulmonary disease (COPD), accompanied by higher morbidity and mortality. The impact of malnutrition on the respiratory system affects the respiratory muscles, the lung parenchyma, and the immune system. In summary, the risk of complications can lead to a worsening of the quality of life of the COPD patient. Also, dyspnea as the main symptom of COPD is the one that produces the greatest loss of quality of life, especially in older patients. The components of our authorized food supplement improve the quality of life of the patient. These components maintain the strength and energy of the patient, help the body to recover and regain its optimal state, help improve the immune system, help reduce the side effects of therapies associated with the control or cure of cancer and help correct nutritional deficiencies. This is the reason why this experimental study aims to improve the quality of life in patients with COPD with a CAT score\>15.
This study is developed in two phases: pilot phase and experimental phase. The pilot phase is preliminary and progressive in order to demonstrate a sufficient effect of improving the quality of life of patients and to be able to continue in an experimental phase with more investigational sites and more patients, and to evaluate other secondary objectives. Once the pilot phase is finished, an intermediate analysis of the results will be carried out to evaluate the magnitude of the variation in quality of life at 3, 6, 9 and 12 months. If the expected success expectations are achieved and it is approved by the Ethics Committee, the study will continue to the experimental phase.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
18
ARACOMPLEX® is an authorized food supplement that contains maca extract, vitamin complexes and ions, and that improves the quality of life of the patient.
Placebo has a composition that makes its weight and organoleptic characteristics are identical to ARACOMPLEX®.
Hospital Universitario Doctor Peset
Valencia, Spain
Change in quality of life
To assess the magnitude of the change from baseline quality of life at 3 months, 6 months, 9 months and 12 months using the COPD Assessment Test (CAT) scale in COPD patients with a CAT score\> 15 who receive ARACOMPLEX® supplementation compared to those patients receiving placebo.
Time frame: 12 months
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