Protocolo de pesquisa clínica para avaliar a eficácia e a segurança de medicamento homeopático individualizado no tratamento e na prevenção da epidemia de COVID-19 / Clinical research protocol to evaluate the efficacy and safety of individualized homeopathic medicine in the treatment and prevention of the COVID-19 epidemic
In addition to the recognized application in chronic diseases, individualized homeopathy can also act in a resolutive or complementary way in acute cases, including epidemicdiseases. However, to achieve this intent, it presents a specific semiological and therapeuticmethodology that must be followed and respected, with the risk of not presenting the desired efficacy and safety. In the case of epidemicdiseases, which due to the virulence of their agents causes a common symptomatological picture in most susceptible individuals, the individualized homeopathic medicine (homeopathic medicine of the epidemic genius) should present similarity with the set of characteristic symptoms and signs of the patients affected in the different stages of each epidemic outbreak. Studies show the efficacy and safety of this prophylactic and/or therapeutic practice in several epidemics of the past. Therefore, after the survey of possible homeopathic drugs individualized from the epidemic genius of each epidemic, its prophylactic and/or large-scale therapeutic application should be supported by previous clinical trials that demonstrate its efficacy and safety, in line with the ethical and bioethical aspects of research involving human beings. Fulfilling these premises of good clinical practice, we developed the current protocol with the objective of investigating, in a randomized, double-blind and placebo-controlled clinical trial, the efficacy and safety of possible individualized homeopathic drugs of epidemic genius of COVID-19, in adjuvant and complementary treatment of patients affected by the disease. If efficacy and safety are confirmed, and only in this condition, the medicine may be used in a generalized and collective manner in the treatment and prevention of the current epidemic. (AU)