Placebo controlled clinical trial of Chanyeanshen capsules in insomnia patients
LIAN Feng-mei
XU Gui-cheng
LIU Kun
LIU Zong-lian
WANG Qiu-feng
QIU Ping
YU Chun-yan
YIN Yi-jian
LI Ning
GAO Lin
Abstract：Objective: To evaluate the efficacy and safety of Chanyeanshen capsule in the treatment of insomnia with internal disturbance of phlegm heat syndrome. Methods: A randomized, double-blind, placebo controlled multi-center clinical trial recruited 108 patients with insomnia, who received a 3-week treatment of Chanyeanshen capsule (n = 72) or placebo (n = 36) at 1h before sleep. The efficacy was evaluated after 1 week and 3 weeks of administration and 1 week after trial by sleep-score, PSQI, fall-sleep time, sleeping-time, syndrome,and symptoms. The safety was evaluated based on the incidences of adverse events, laboratory and electrocardiography examination. Results: The sleep-score and PSQI were reduced after treatment in the trial group. Chanyeanshen capsule shortened fall-sleep time, prolonged sleeping-time, relieved the symptoms. The trail drug showed more stronge efficacy to treat insomnia than placebo. Conclusion: Chanyeanshen capsule provides an effective and safe therapeutic option for insomnia patients.
Keywords：insomiaplaceboTCMChanyeanshen capsule
Publication Date：2009-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：5( 2056-2060 )