| Abstract: | ABSTRACT: BACKGROUND: Chronic obstructive pulmonary disease (COPD) has become a major public health problem worldwide because of its high and increasing prevalence, morbidity, and mortality. Little attention has been paid to earlier stages of COPD or before it has developed. It has reported that TCM may have some advantages in relieving symptoms, reducing the incidence of COPD exacerbations. It is hypothesis that in patients with COPD will benefit with the therapy with TCM treatment according to syndrome differentiation. Methods and design: A prospective, multi-center, double-blinded, double-dummy and randomized controlled method was conducted to test the therapeutic effects of TCM treatment with syndrome differentiation. A total of 504 patients will be enrolled into this study with 252 in each treatment group. Patients will receive medication according to their assigned group. TCM for COPD administered twice daily over 52 weeks, all patients followed 52 weeks. The FEV1 and exacerbations, will be used as the primary outcome measures. The quality of life and the modified medical research council dyspnea (MMRC) scale and The Six-Minute Walk Test (6MWD) will be used as the secondary outcome measures. DISCUSSION: It is hypothesis that in patients with COPD will benefit with the therapy with TCM treatment according to syndrome differentiation. Trial registration: This study is registered at ClinicalTrials.gov, NCT01486186 KEYWORDS: Chronic obstructive pulmonary disease, Traditional Chinese Medicine, treatment, Clinical trials. |
