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临床试验/ITMCTR2000003221
ITMCTR2000003221尚未招募未知

Research on health state intervention by active and passive ways and management techniques based on the combination of traditional Chinese medicine constitution (subtopic 3) : clinical evaluation of intervention techniques for subthreshold depression, insomnia and mild cognitive impairment

Beijing University of Chinese Medicine0 个研究点开始时间: 待定最近更新:
适应症

试验速览

阶段
未知
状态
尚未招募
发起方

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 59(—)
性别
All

入选标准

  • 1. Patients who meet the diagnostic criteria of insomnia in western medicine;
  • The following conditions are met:
  • (1) One or more of the following phenomena observed by the patient or his parents or caregivers:
  • Difficulty in falling asleep;
  • Difficulty in sleep maintenance;
  • The awakening time is earlier than expected;
  • Refuse to go to sleep till the time of sleeping;
  • It is difficult to sleep without parents or caregivers;
  • (2) One or more of the following phenomena related to nocturnal sleep difficulties observed by the patient's chief complaint or his parents or caregivers:
  • Fatigue or malaise;
  • Decreased attention, concentration or memory;
  • Social, family, professional or learning decline;
  • Emotional instability or irritability;
  • Daytime sleepiness;
  • Behavioral problems, such as overactive, impulsive, or aggressive;
  • The decrease of magic power, energy or work initiative;
  • Easy to make mistakes or accidents;
  • Very concerned or dissatisfied with their sleep quality.
  • (3) There are still complaints of sleep wakefulness difficulty with sufficient sleep time, opportunity and suitable sleep environment;
  • (4) The above-mentioned sleep difficulties and related daytime symptoms occur at least 3 times a week;
  • (5) The above sleep difficulties and related daytime symptoms lasted at least 3 months;
  • (6) These sleep difficulties and related daytime symptoms cannot be better explained by other sleep disorders.
  • 2. Patients between 18 and 59 years old;
  • 3. Patients with conscious, clear and available language communication;
  • 4. Patients without olfactory disturbance;
  • 5. Patients with Pittsburgh sleep quality index > 5;
  • 6. Patients who have not used sleeping drugs or have stopped using sleeping drugs for more than one month;
  • 7. Patients who understand and can cooperate with the corresponding trial scheme and are willing to sign the informed consent;
  • Those who meet all the above conditions are included in the study.

排除标准

  • 1. All patients with general diseases such as pain, fever, cough, operation, etc., as well as external environmental interference factors causing insomnia;
  • 2. The patients with anxiety or depression, or the patients with serious mental diseases that affect sleep, such as the patients with severe mental diseases;
  • 3. Pregnancy, lactation and objects with pregnancy plan;
  • 4. Patients who are allergic to aromatic drugs or have a history of serious adverse reactions and severe allergic constitution;
  • 5. Patients with other serious circulatory system, hematopoietic system, digestive system, endocrine system and other diseases;
  • 6. Patients who are participating in clinical trials of other drugs.
  • Those who meet any of the above conditions are excluded from this study.

研究者

发起方
Beijing University of Chinese Medicine

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