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临床试验/ITMCTR2000002929
ITMCTR2000002929尚未招募4 期

Efficacy and Safety Evaluation of Yangxin Dawaimixike Migao in the Treatment of Insomnia (Qi Stagnation and Blood Stasis Syndrome): a block randomized, double-blind, double simulation, positive-contro

Guang'anmen Hospital, China Academy of Chinese Medical Sciences.0 个研究点开始时间: 待定最近更新:
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简要总结

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研究设计

研究类型
Interventional study

入排标准

年龄范围
18 至 65(—)
性别
All

入选标准

  • 2. Those who meet the syndrome differentiation of TCM as Qi stagnation and blood stasis syndrome;
  • 3. Sleep quality PSQI score > 7 points;
  • 4. Insomnia Severity Index Scale score >= 8 points;
  • 5. Insomnia symptoms appear more than 3 times a week for more than 1 month;
  • 6. Persons aged 18 to 65 (including 18 and 65), regardless of gender;
  • 7. Voluntarily sign the informed consent form.

排除标准

  • 1. Insomnia caused by certain physical diseases, organic diseases of the brain, and drug reactions;
  • 2. Insomnia caused by schizophrenia, depression, anxiety or other mental disorders; patients with HAMD score of 17 or more when enrolled; or total score of HAMA of 14 or more;
  • 3. Sleep disorders due to poor sleep hygiene, jet lag syndrome, shift work, and other irregular work schedules; sleep apnea syndrome, narcolepsy, and typical insomnia caused by other sleep disorders such as night terrors and nightmares;
  • 4. Combined liver and kidney damage, ALT, AST >= 1.5 times the upper limit of normal value, or Cr > the upper limit of normal value; combined with serious primary diseases such as hematopoietic system;
  • 5. Drug or alcohol dependent persons;
  • 6. People with allergies or allergies to this drug;
  • 7. Poor blood glucose control;
  • 8. Pregnant or intended pregnant or lactating women;
  • 9. Have used sleeping pills, antidepressants, anti-anxiety drugs or other drugs that affect the central nervous system in the last two weeks or psychological and physical therapy;
  • 10. Participants in other clinical trials in the past 3 months;
  • 11. Researchers consider others unsuitable for participants.

研究者

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