A Single-Central, Randomized, Double-Blinded, Placebo-Controlled, Crossover Trial Protocol: A Clinical Effect Evaluation Study on the TCM Comprehensive Intervention Program for Chronic Heart Failure

Background. It is known to all the doctors and patients that both the morality and incidence rate of chronic heart failure (CHF) are quite high among various heart diseases. Traditional Chinese medicine (TCM) comprehensive intervention becomes a rising prospective therapy for patients with CHF. Considering the efficacy of TCM, the study aims to test the safety as well as the validity of TCM comprehensive intervention in patients who are struggling with CHF. Methods. The study is an essentially randomized, single-central, placebo-controlled, double-blinded crossover trial. Eighty-two eligible subjects aged 18–75 years with CHF are supposed to be recruited. According to the subject plan, all the patients will be divided into group A and B. The patients in group A will receive oral Qishen Taohong granules (QTGs) combined with TCM external treatment and standard Western medicine for four weeks. After that, a 2-week washout would be proceeded; this group will be reallocated to another four weeks with oral placebo granules combined with TCM external treatment and standard Western medicine. In contrast, group B will perform the opposite protocol. The primary outcome conforms to the classification from the New York Heart Association (NYHA). Meanwhile, the secondary outcomes are echocardiogram, N-terminal pro-B-type natriuretic peptide (NT-proBNP), Chronic Heart Failure Quality of Life Scale of Integrated Chinese and Western Medicine (CHFQLS), TCM syndrome, symptom, sign, six-minute walk test (6MWT), Pittsburgh Sleep Quality Index (PSQI), Montreal cognitive assessment (MoCA), major adverse cardiovascular events (MACEs), and metabolomics. Discussion. Based on conventional treatments, TCM comprehensive intervention may further improve the patients’ cardiac function and then enhance their quality of life. The results will provide high-quality evidence of TCM comprehensive intervention in treating CHF.