The correlation between body constitution of traditional Chinese medicine（TCM） and disease is one of the key scientific issues of TCM constitutionology. Evaluating and verifying the correlation between constitution and disease through clinical research is of great significance to etiology and treatment of TCM. From the perspective of clinical epidemiology

this paper analyzed various specificities and methodological challenges in clinical research on the correlation between constitution and disease

including the lag in clinical methodological research related to constitution and diseases

the constitution and disease relationship is a "weak correlation" susceptible to confounding factors

the specificity of constitution itself increases difficulty in the research of constitution and disease relationship. From the research design type

the inclusion of research objects

the quality control measures in the measurement

the processing of research data

etc.

this paper proposed the matters needing attention and related suggestions in the design and implementation of clinical research on this issue

so as to provide reference for improving the methodological quality of clinical research on the correlation between constitution and disease.