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CLINICAL TRIAL article

Front. Neurol.

Sec. Sleep Disorders

Volume 16 - 2025 | doi: 10.3389/fneur.2025.1555010

Effectiveness of Fermentation Broth of Cordyceps sinensis for Primary Insomnia: A Randomized Clinical Trial with Digital Health Tool

Provisionally accepted
Shuting  ZhaoShuting Zhao1Ziqian  WangZiqian Wang2,3Xiaxia  FanXiaxia Fan1,4Xuanhao  ShuXuanhao Shu2,3Qiao  ChenQiao Chen1Yibo  ZhouYibo Zhou1Yongzhi  FuYongzhi Fu1Zheng  YuZheng Yu1Marcin  GrzegorzekMarcin Grzegorzek5,6Xinyu  HuangXinyu Huang5Chengwen  ZhengChengwen Zheng4Yanxiong  GanYanxiong Gan1*Chuanbiao  WenChuanbiao Wen1,7*
  • 1School of Intelligent Medicine, Chengdu University of Traditional Chinese Medicine, 1166 Liutai Avenue, Wenjiang District, Chengdu, Sichuan 611137, China
  • 2School of Acupuncture and Tuina, Chengdu University of Traditional Chinese Medicine, 1166 Liutai Avenue, Wenjiang District, Chengdu, Sichuan 611137, China
  • 3Key Laboratory of Acupuncture for Senile Disease (Chengdu University of TCM), Ministry of Education, Chengdu, Sichuan 611137, China
  • 4Chengdu Zen Healing TCM Clinic, Ltd., Chengdu, Sichuan 610093, China
  • 5Institute for Medical Biometry and Statistics, University of Lübeck, Lübeck, Schleswig-Holstein, Germany
  • 6German Research Center for Artificial Intelligence (DFKI), Kaiserslautern, Rheinland-Pfalz, Germany
  • 7Sichuan Provincial Engineering Technology Research Center for Digitalization of Traditional Chinese Medicine, Chengdu, Sichuan 611137, China

The final, formatted version of the article will be published soon.

Background: Cordyceps sinensis is widely used in Traditional Chinese Medicine and dietary supplements to tonify the kidney, lung, and heart, as well as to calm the mind.The fermentation broth of Cordyceps sinensis (FBCS), containing cordycepin, has shown potential in various healthcare applications.Ninety patients with primary insomnia were divided into two groups: the FBCS group (n=45) and the control group (n=45). The FBCS group received Cordyceps fermentation liquid drink (150 ml/day), while the control group received a placebo (150 ml/day). Both groups were supported by Digital Health Tools (DHT) for medication supervision. Pittsburgh Sleep Quality Index (PSQI) scores were assessed and collected through the DHT application at the initial baseline period, 14, and 28 days after treatment.: Significant main effects of time and time × group interaction on the PSQI total score and all subcomponents. Significant group effects were also observed for most subcomponents, except for Sleep Disturbances and Daytime Function, indicating greater improvements in the FBCS group over time. After 14 and 28 days of FBCS consumption, the treatment group demonstrated greater reductions in PSQI total scores compared to the control group. Subcomponent analysis revealed greater improvements in the FBCS group compared to the control group at both time points. Specifically, Sleep Quality scores decreased by -0.89 vs. -0.50 at Day 14 and -1.32 vs. -0.45 at Day 28 Sleep Onset Latency improved by -0.75 vs. -0.20 at Day 14 and -1.32 vs. -0.27 at Day 28. Sleep Duration scores decreased by -0.86 vs. -0.20 at Day 14 and -1.20 vs. -0.23 at Day 28. Sleep Efficiency showed a decline of -0.82 vs. +0.23 at Day 14 and -1.11 vs. +0.30 at Day 28. For Sleep Disturbances, the FBCS group improved by -0.41 vs. -0.05 at Day 14 and -0.55 vs. +0.14 at Day 28. Lastly, Daytime Function scores decreased by -0.73 vs. -0.07 at Day 14 and -0.95 vs. -0.18 at Day 28 Conclusion: The FBCS demonstrated significant effectiveness in improving overall sleep outcomes among patients with primary insomnia. Moreover, the use of DHT enhanced patient adherence and facilitated reliable data collection.

Keywords: Primary insomnia, Cordyceps sinensis, Fermentation broth, Digital health tool, Pittsburgh Sleep Quality Index

Received: 07 Feb 2025; Accepted: 01 Jul 2025.

Copyright: © 2025 Zhao, Wang, Fan, Shu, Chen, Zhou, Fu, Yu, Grzegorzek, Huang, Zheng, Gan and Wen. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

* Correspondence:
Yanxiong Gan, School of Intelligent Medicine, Chengdu University of Traditional Chinese Medicine, 1166 Liutai Avenue, Wenjiang District, Chengdu, Sichuan 611137, China
Chuanbiao Wen, School of Intelligent Medicine, Chengdu University of Traditional Chinese Medicine, 1166 Liutai Avenue, Wenjiang District, Chengdu, Sichuan 611137, China

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