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

Phase 4

Not yet recruiting

• Conditions: wakefulness

• Registration Number: ITMCTR2000002929
• Lead Sponsor: Guang'anmen Hospital, China Academy of Chinese Medical Sciences.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-02-20

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified