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
适应症
试验速览
研究概览
简要总结
暂无简介。
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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