Objective To evaluate the efficacy and safety of Xinren Shen’an Capsule（ 心仁神安胶囊） in treating insomnia of fire excess due to Yin-deficiency with phlegm syndrome. Methods Using multi-center

randomized

double-blind

placebo parallel controlled method

the researchers divided 115 patients into the treatment group（ 57cases） and the control group（ 58 cases）. Sleep health education was conducted in both groups. In addition

the treatment group was given Xinren Shen’ an Capsule

and the control group was given placebo

with 3 capsules each time

3 times per day

for 28 days. The researchers observed the total score of Pittsburgh Sleep Quality Index（ PSQI） and the score of 7 factors

Chinese medicine symptom score in the two groups before and after treatment

and evaluated the curative effect

Chinese medicine syndrome efficacy and safety after treatment. Results In the treatment group

the total effective rate and the Chinese medicine syndrome curative effect were 70. 18% and 49. 12% respectively

which were significantly higher than 20. 69% and 5. 17% in the control group（ P < 0. 01）. After treatment

the total score of PSQI in the two groups were significantly lower than that before treatment（ P < 0. 01）

and the improvement of the treatment group was superior to that of the control group（ P < 0. 01）. Except factor hypnotic drugs

PSQI factors score distribution after treatment in the two groups had significant difference with those before treatment（ P < 0. 01）. The improvement of subjective sleep quality

time of falling asleep

sleep time

sleep efficiency

daytime dysfunction after treatment in the treatment group was all better than that in the control group（ P <0. 01）. Except chest and epigastric fullness and distress in the control group

the Chinese medicine symptoms in the two groups were significantly improved after treatment（ P < 0. 05 or P < 0. 01）. Except mouth bitterness

tinnitus

night sweat

soreness and weakness of waist and knees

the score improvement of other Chinese medicine symptoms was better than that of the control group（ P < 0. 05 or P < 0. 01）. There was no significant adverse reaction in both groups during the treatment. Conclusion Xinren Shen’an Capsule in treating insomnia with fire excess due to Yindeficiency with phlegm syndrome seems to have definite curative effect

and can significantly improve the symptoms.