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| A randomized,double-blind,parallel controlled,multicenter clinical study of Tianma Xingnao Capsule in the treatment of primary insomnia (liver and kidney deficiency,liver-wind disturbance) |
| Hits 721 Download times 485 Received:December 20, 2021 |
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| DOI
10.11656/j.issn.1673-9043.2022.02.14 |
| Key Words
Tianma Xingnao Capsule;primary insomnia;liver and kidney deficiency;liver-wind disturbance;multicenter;randomized |
| Author Name | Affiliation | | HU Linyuan | Yunnan Provincial Hospital of Traditional Chinese Medicine, Kunnan 650021, China | | CHEN Wei | Yunnan Provincial Hospital of Traditional Chinese Medicine, Kunnan 650021, China | | WEI Mingqing | Beijing University of Chinese Medicine Dongzhimen Hospital, Beijing 100000, China | | FANG Zhiyong | Xiangyang Hospital of Traditional Chinese Medicine, Xiangyang 441000, China | | QU Yun | West China Hospital, Sichuan University, Chengdu 610041, China | | DU Jumei | Second Affiliated Hospital of Shanxi University of Traditional Chinese Medicine, Xianyang 712000, China | | CHEN Guanghui | Shiyan People's Hospital, Shiyan 442008, China | | WANG Yumei | First Affiliated Hospital of Xinxiang Medical University, Xinxiang 453100, China | | PAN Pingkang | Ankang People's Hospital, Ankang 725000, China | | LI Feng | First Affiliated Hospital of the Fourth Military Medical University of the Chinese People's Liberation Army, Xi'an 710032, China | | LIN Yaming | Yunnan Provincial Hospital of Traditional Chinese Medicine, Kunnan 650021, China |
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| Abstract
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| [Objective] To evaluate the clinical efficacy and safety of Tianma Xingnao Capsule in the treatment of primary insomnia (liver and kidney deficiency,liver disturbance). [Methods] A randomized,double blind,parallel controlled and multicenter trial method was used for clinical research. A total of 144 cases of patients with primary insomnia(liver and kidney deficiency,liver-wind disturbance) from eight hospitals were randomly divided into experimental group(108 cases) and control group(36 cases). The experimental group was given Tianma Xingnao Capsule and compound Gouteng Tablet simulator,while the control group was given compound Gouteng Tablet and Tianma Xingnao Capsule simulator. The two groups were treated for 8 weeks. The traditional Chinese medicine syndrome curative effects,Pittsburgh sleep quality index (PSQI),insomnia severity index,sleep diary score (sleep duration,time to sleep,arousal times) and safety were compared between the two groups. [Results] The total effective rate and PSQI of experimental group was superior than that of the control group(P<0.05). The experimental group also have better performance in sleep duration and time to sleep of sleep diary score than control group (P<0.05). There was no significant difference in the incidences of adverse events between the two groups(P>0.05). [Conclusion] Tianma Xingnao Capsule in the treatment of insomnia(liver and kidney deficiency,liver-wind disturbance) is safe and effective, which can improve the clinical symptoms,shorten the time needed to sleep,prolong the sleep time and reduce the number of sleep wakes,so as to improve the quality of sleep. |
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