A randomized, double-blind, placebo-parallel-controlled, multicenter clinical trial reevaluating the efficacy and safety of Qiye Shenan dropping pill in the treatment of insomnia (qi deficiency syndrome)

Phase 4

Recruiting

• Conditions: Anhypnosis

• Registration Number: ITMCTR2100004546
• Lead Sponsor: Xiyuan Hospital, Chinese Academy of Chinese Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

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

Inclusion Criteria

1. Patients who meet the diagnostic criteria of insomnia;
2. Patients who meet the diagnostic criteria of insomnia (Qi deficiency syndrome) in TCM;
3. Aged 45-75 years;
4. The cumulative score of 7 components of Pittsburgh sleep quality index was 5;
5. The subjects with informed consent were voluntary and signed informed consent.

Exclusion Criteria

1. Shift workers;
2. Subjects with secondary insomnia (insomnia related to other mental disorders, sleep disorders caused by medical diseases (insomnia), sleep disorders caused by substances (insomnia), environmental sleep disorders, etc.;
3. Patients with other sleep disorders: obstructive sleep apnea syndrome (OSAS), restless legs syndrome;
4. The score of Hamilton Depression Scale (HAMD) was more than 17, and the score of Hamilton Anxiety Scale (HAMA) was more than 14;
5. The subjects who use other traditional Chinese medicine or Chinese patent medicine or non short acting sedative hypnotics, antidepressants and anxiolytics to treat insomnia within one week; or the subjects who are receiving dual antiplatelet therapy or monoclonal antiplatelet therapy and are prone to bleeding;
6. Pregnant women and lactating women;
7. Patients with severe primary heart, liver, kidney, blood or other serious diseases affecting their survival have abnormal liver and kidney functions, ALT and AST >= 1.5 times of the upper limit of normal value, Cr > the upper limit of normal value;
8. Subjects with suspected or history of alcohol or drug abuse;
9. Subjects with allergic constitution, such as being allergic to two or more drugs or foods;
10. Subjects known to be allergic to drug components;
11. Subjects who participated in clinical trials of other drugs in recent 3 months.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Pittsburgh and sleep quality Index score;Fatigue Severity Scale Score (FSS);

Secondary Outcome Measures

Name	Time	Method
ISI score for insomnia severity index;