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Comprehensive Traditional Chinese Medicine Intervention Combined with Digital Follow-up: A Correlative Study on Insomnia

Comprehensive Traditional Chinese Medicine Intervention Combined with Digital Follow-up: A Correlative Study on Insomnia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600118376
Enrollment
Unknown
Registered
2026-02-04
Start date
2026-02-09
Completion date
Unknown
Last updated
2026-02-09

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

Conditions

Insomnia

Interventions

Experimental group:1. Daily Life Regulation: Patients were required to clock in their sleep duration every day. They were advised to go to bed between 22:00 and 23:00 and get up between 6:00 and 7:00

Sponsors

Hangzhou Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Meets the diagnostic criteria for non-organic insomnia as defined in ICD-10; 2. Retrospective study: Complete records of comprehensive traditional Chinese medicine therapy (including intervention plan and efficacy assessment); Interventional study: Total score of Pittsburgh Sleep Quality Index (PSQI) >= 8 points, score of Generalized Anxiety Disorder Scale (GAD-7) >= 5 points, or score of Patient Health Questionnaire-9 (PHQ-9) >= 5 points (indicating mild to moderate anxiety/depression); 3. Age 18-70 years old, gender not restricted; 4. Interventional study: Voluntary participation in digital follow-up and proficient in using smartphone applications.

Exclusion criteria

Exclusion criteria: 1. Secondary insomnia (caused by severe mental disorders, neurological diseases, endocrine disorders, etc.); 2. Severe anxiety/depression (GAD-7 score >= 15 or PHQ-9 score >= 15) or with suicidal risk; 3. Pregnant or lactating women; 4. Those who cannot cooperate with follow-up (such as cognitive impairment, severe physical diseases).

Design outcomes

Primary

MeasureTime frame
Pittsburgh Sleep Quality Index;Generalized Anxiety Disorder-7;Patient Health Questiomnare-9;Dysfunctional Beliefs and Attitudes about Sleep Scale;TCM Syndrome Score;

Countries

China

Contacts

Public ContactYilin Meng

Hangzhou Hospital of Traditional Chinese Medicine

402548973@qq.com+86 178 1686 2849

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 15, 2026