Quality of Life Clinical Trial
Official title:
The Study on the Effects of Traditional Chinese Medicine Through a Series of N-of-1 Trials Based on the Mathematical Model of "Carryover Effect"
Treatment based on syndrome differentiation is the essence of traditional Chinese Medicine(TCM) and forms the individualized treatment. N-of-1 trials may be a good clinical effect evaluation method for the individualized treatment of TCM. This study aims to compare: (1) the efficacy of syndrome differentiation(individualized decoction) with placebo, (2)the efficacy of syndrome differentiation(individualized decoction) with the same prescription minus heat-clearing Chinese herbs, for patients with stable bronchiectasis through N-of-1 trials.
Traditional Chinese medicine is one of the important part of complementary and alternative
medicine in the world, and it plays increasingly important role in the international medical
practice. Treatment based on syndrome differentiation is the essence of traditional Chinese
Medicine (TCM) and forms the individualized treatment. However, this individualized TCM
intervention often makes it difficult for population-based RCTs to carry out a standard
form. N-of-1 trials may be a good clinical effect evaluation method for the individualized
treatment of TCM.
The key hypothesis of this study is that: (1) the efficacy of syndrome
differentiation(individualized decoction) will be better than placebo in patients with
stable bronchiectasis through N-of-1 trials. (2) the efficacy of syndrome
differentiation(individualized decoction) will be better than the same prescription minus
heat-clearing Chinese herbs in patients with stable bronchiectasis through N-of-1 trials.
The difference of efficacy may be various according to the individual severity of
phlegm-heat.
In this study, We will conduct a single center N-of-1 trials in 36 patients with stable
bronchiectasis without hemoptysis and respiratory failure. These N-of-1 trials will be
randomized, double-blind, crossover comparisons of individualized herbal decoction with
control decoction within individual patients. Each n-of-1 trial has 3 pairs of treatment
periods. The duration of each treatment period will be 4 weeks. We will compare :(1) the
efficacy of syndrome differentiation(individualized decoction) with placebo, (2) the
efficacy of syndrome differentiation(individualized decoction) with the same prescription
minus heat-clearing Chinese herbs, in patients with stable bronchiectasis through N-of-1
trials. The primary outcome is patient self-reported symptoms(such as cough, expectoration,
shortness of breath, chest pain, and fatigue) scores on a 7 point visual analogue scale.
Secondary outcomes are 24-hour sputum volume and CAT(The COPD Assessment Test) scores. We
use paired t test for single case. Mixed effects model taking account of "Carryover Effects"
and meta-analysis will be used for a series of N-of-1 trials as a group.
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