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Clinical randomized controlled study of Anshui drink in the treatment of insomnia disorder

Clinical randomized controlled study of Anshui drink in the treatment of insomnia disorder

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001244
Enrollment
Unknown
Registered
2025-06-22
Start date
2025-06-25
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

insomnia

Interventions

control group:Take Zolpidem tartrate tablet 5mg every night before bed
experimental group:Application of four kinds of decoction: 30g sour jujube kernel 15g lily 15g yellow essence 15g salvia miltiorrhiza decoction one dose a day divided into three times 100 ml each time

Sponsors

No.971 Hospital of PLA Navy
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Meeting the diagnostic criteria for insomnia disorder: According to the diagnostic criteria for insomnia disorder in the "Chinese Adult Insomnia Diagnosis and Treatment Guidelines (2017 Edition)" the patient complains of difficulty in both falling asleep and maintaining sleep with shortened sleep duration accompanied by decreased sleep quality and daytime functional impairment and the duration is = 4 weeks; (2) Age 18 to 75 years old; (3) PSQI score = 7 points; (4) No use of insomnia-related medications for more than 2 weeks; (5) The patient agrees to participate in this study.

Exclusion criteria

Exclusion criteria: Those who are allergic to the drugs used in this study; patients with schizophrenia or severe depression; those with liver or kidney dysfunction.

Design outcomes

Primary

MeasureTime frame
Pittsburgh Sleep Quality Index;

Secondary

MeasureTime frame
Serum interleukin - 6;Serum ?-aminobutyric acid;Self-Rating Anxiety Scale;Serum 5-HT;Serum tumor necrosis factor - a;Serum glutamate;Self-Rating Depression Scale;

Countries

China

Contacts

Public ContactYinglu Feng

No.971 Hospital of PLA Navy

1715871716@qq.com18610528063

Outcome results

None listed

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