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Multi-center clinical study for Chinese medicine An-Shen prescription in the treatment of adult chronic insomnia

Research on prevention and treatment of insomnia and sleep health management program based on the theory of 'three causes and measures theory'

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR1900002765
Enrollment
Unknown
Registered
2019-11-20
Start date
2020-01-01
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

insomnia

Interventions

Sponsors

Hubei Provincial Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
clinical efficacy;Pittsburgh sleep quality index (PSQI);sleep efficiency;

Secondary

MeasureTime frame
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);

Countries

China

Contacts

Public ContactLing Liu
lingliu07199@aliyun.com+86 18971537282

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026