Bronchiectasis Clinical Trial
Official title:
Effects of Traditional Chinese Medicine on Bronchiectasis Patients: A Multi-center, Randomized, Double-blind, Controlled Trial
The aim of this study is to evaluate the effectiveness of Traditional Chinese Medicine (TCM) on patients with clinically stable bronchiectasis by a multi-center, randomized, double-blind, controlled trial: one, TCM treatments based on syndrome differentiation; the other, a placebo of TCM treatment.
Bronchiectasis is a common and frequently occurring respiratory disease, with more
hospitalization rate and mortality, poor quality of life and heavy financial burden. The main
clinical manifestations are persistent or recurrent cough, expectoration, sometimes
accompanied by hemoptysis, which can cause respiratory dysfunction and chronic pulmonary
heart disease. There are some randomized controlled trials of TCM for bronchiectasis, and
have the effect in the treatment of bronchiectasis, reducing the number of acute aggravation
and alleviating dyspnea. However, some TCM interventions lack comprehensive syndrome
differentiation and the placebo control.
This is a multi-center, randomized, double-blind, controlled trial to compare the efficacy to
evaluate the effectiveness of TCM on patients with clinically stable bronchiectasis. 216
subjects will be randomly assigned to one therapies (TCM treatments based on syndrome
differentiation) and the other therapy (placebo of TCM treatment) for 24 weeks. After the
treatment period, the subjects will be followed up for 24 weeks. The primary outcomes include
the frequency of bronchiectasis exacerbation, and the secondary outcomes include quality of
life (SGRQ, LCQ, QOL-B), pulmonary function, safety observation index.
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