Objective: To assess the clinical efficacy, safety and compliance of tianwang buxin decoction (TWBXD) combined with dormancy hygiene education (DHE) and TWBXD alone in treatment of sub-healthy insomnia patients of yin deficiency fire excess syndrome.
Methods: The multi-centered, single blinded randomized clinical trial design was adopted. One hundred and one sub-healthy insomnia subjects of yin deficiency fire excess syndrome were randomly assigned to two groups.