Clinical Evaluation For The Efficacy And Safty Of Mao Sao Tong Soft Capsule In The Treatment Of Functional Constipation

Objective:To evaluate the efficacy and safty of mao sao tong soft capsule in the treatment of functional constipation in comparison with ma ren soft capsule. Methods:A total of 240 patients with functional constipation were enrolled in this multi-center , randomized,double-blinded,double-simulation,controlled , parallel-group study .They received mao sao tong soft capsule(1.5g,bid,n=120) or ma ren soft capsule(0.6g,qd,n=120) for 3 weeks. Results: At the end of the study, ITT is 230 patients and PP is 223 patients, 17 patients falling. There are no marked statistic significance in the demology datum in both groups.After 3 weeks ,the complete remission of constipation was reported by significantly higher number of patients treated with mao sao tong soft capsule in comparison with ma ren soft capsule group (3 weeks: functional constipation:ITT 92.11%,85.34%,P<0.05,PP 94.55%,86.73%,P<0.01 ; the traditional Chinese medicine : ITT 89.47 % ,84.48% , P<0.05 ; PP 91.82% ,85.84% ,P<0.01 ).There was no any adverse effect in both groups . Conclusion : Mao sao tong soft capsul is an effective and safe agent in the treatment of functional constipation.