NCT04815499

Effects of a Food Supplement on Quality of Life in Patients With Chronic Obstructive Pulmonary Disease.

Study of the Impact on Quality of Life With ARACOMPLEX® Food Supplement Versus Placebo in Chronic Obstructive Pulmonary Disease Patients With a CAT Score> 15.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Arafarma Group, S.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Food supplement	ARACOMPLEX® is an authorized food supplement that contains maca extract, vitamin complexes and ions, and that improves the quality of life of the patient.
DIETARY_SUPPLEMENT	Placebo	Placebo has a composition that makes its weight and organoleptic characteristics are identical to ARACOMPLEX®.

Timeline

• Start date: 2020-01-14
• Primary completion: 2022-09-15
• Completion: 2022-11-03
• First posted: 2021-03-25
• Last updated: 2022-11-15

Locations

1 site across 1 country: Spain