Multi-center clinical study for Chinese medicine An-Shen prescription in the treatment of adult chronic insomnia
Phase 1
- Conditions
- insomnia
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
1. Patients with chronic insomnia whose disease duration is longer than 6 months;
2. Aged 18-80 years old;
3. Ppatients who did not take antidepressant, anti-anxiety, sedative and hypnotic drugs within one month;
4. Ppatients who can understand the scale and actively cooperate with the treatment;
5. Sign informed consent.
Exclusion Criteria
1. Insomnia caused by serious illness;
2. psychopath and patients with severe anxiety or depression,;
3. Pregnant or lactating patients.
4. Insomniacs participating in other clinical observations
5. For other reasons the researchers did not consider it appropriate to participate in clinical trials;
Those who meet any one of the above conditions would be excluded.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method clinical efficacy;Pittsburgh sleep quality index (PSQI);sleep efficiency;
- Secondary Outcome Measures
Name Time Method Interleukin-1;SPIEGEL;the scores of Athens insomnia scale (AIS);the scores of Hamilton's depression scale (HAMD);dopamine;Interleukin - 6;sleep diaries;5-hydroxytryptamine;the scores of fatigue scale-14 (FS-14);the scores of Hamilton's anxiety scale (HAMA);