Objective To explore the clinical efficacy and safety evaluation of functional constipation treated by TCM syndrome differentiation. Methods 160 patients with functional constipation were randomly divided into two groups by random number table. The experimental group and the control group had 80 cases in each group. The control group received lactulose treatment. The experimental group judged the TCM syndromes of the patients and adopted the corresponding Decoction of traditional Chinese medicine combined with TCM characteristic therapy for 8 weeks. Finally, 70 cases were in the experimental group and 69 cases in control group. The patients with functional constipation were observed by syndrome score, quality of life scale and medication safety before and after treatment. Results(1) The symptoms of constipation patients were significantly improved in the experimental group, which was superior to the control group in the aspects of stool characteristics, difficulty in defecation, excessive forced defecation, frequency of defecation, falling down, defecation time, limbs not warm, long urine, thirst and drinking, dizziness and tinnitus, hand-foot-heart heat, fatigue and insomnia; (2) The experimental group was superior to the control group in the treatment of constipation. The treatment group can significantly improve the quality of life of patients, and its efficacy is better than that of the control group in the four dimensions of physical discomfort, psychosocial discomfort, anxiety and worried, and satisfaction. (3) The four syndrome types of the experimental group are used by Buzhong Yiqi Decoction, Jichuan Decoction, Zengye Decoction with Runchang Pill and Qilang Decoction combined with TCM characteristic therapy. Four kinds of treatment have the same curative effect. (4) Clinical use is safe, no toxic and no side effects. Conclusion TCM syndrome differentiation therapy is effective, safe and worth popularizing.