Chinese Medicine in Treating Insomnia

This is a randomized, double-blinded, placebo-controlled clinical trial. Eligible participants will randomized into either treatment group (CM granules) or placebo group (placebo granules) for 6 weeks, followed by a post-treatment visit at week 9. The primary outcome is the change in Pittsburgh Sleep Quality Index (PSQI) at week 6.

Insomnia is one of the most general health concerns in the society. It is generally defined as a self-reported sleep disorder problem of the patient, characterized by difficulty in falling asleep, or difficulty maintaining sleep. According to American Insomnia Survey, 42.6% of the respondents reported of having at least one of the insomnia symptoms. Chinese medicine can be an alternative to the treatment of insomnia. Suan Zao Ren Tang and Tian Wang Bu Xin Dan are two of the most common Chinese herbal formulae to treat insomnia, for which Suan Zao Ren Tang has the functions to nourish blood and calm the mind, clear heat and alleviate vexation, and Tian Wang Bu Xin Dan has the function to nourish the heart and calm the mind, and nourish Yin and clear heat. In this study, we will modify the formula of Suan ZaoRen Tang with TianWang BuXin Dan, and observe the effectiveness and safety of the study drug.