A Series of N-of-1 Trials of Traditional Chinese Medicine Based on Bayesian Method
Status:
Recruiting
Trial end date:
2022-12-31
Target enrollment:
Participant gender:
Summary
The guiding role of parallel randomized controlled trials in clinical practice is limited due
to the insufficiency of individual information. Our previous studies showed that Single case
randomized controlled trials (referred to as N-of-1 trials) could reflect the individualized
characteristics of traditional Chinese medicine (TCM) syndrome differentiation with good
feasibility, but the sensitivity was low.
This study aims to compare the efficacy of treatment based on syndrome differentiation with
controlled decoctions (placebo, and the method of strengthening the body resistance and
removing phlegm) among patients with stable bronchiectasis through a series of N-of-1 trials
(single-patient, double-blind, randomized, multiple crossover design), with the 7
point-likert scale of the most concerned symptoms as the main outcome. Hierarchical Bayesian
statistical methods and some parameters and variables will be introduced, such as TCM
syndrome type, potential residue effect of TCM, etc. The sensitivity and applicability of
various mathematical models (Hierarchical Bayesian, paired t-test and Meta-analysis) for
N-of-1 trials of TCM will be tested, for the purpose of improving the sensitivity and
applicability of N-of-1 trials of TCM both on individual and group levels.
Phase:
Phase 4
Details
Lead Sponsor:
Shanghai University of Traditional Chinese Medicine
Collaborator:
Guangzhou University of Traditional Chinese Medicine