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Clinical evaluation for primary complex points on improving the effect of obstinate insomnia and its influence on changes of brain transmitters

Clinical evaluation for primary complex points on improving the effect of obstinate insomnia and its influence on changes of brain transmitters

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000003422
Enrollment
Unknown
Registered
2020-06-22
Start date
2020-07-01
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

Persistent insomnia

Interventions

Sponsors

Third Affiliated Hospital of Henan University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Insomnia patients who meet the criteria of TCM diagnosis and western medicine diagnosis; 2. between 18 and 65 years of age (including 18 and 65 years of age); 3. No insomnia related treatment was received 1 week before treatment; 4. Voluntary participation in this trial, strictly abide by the treatment prescribed in this study, obey the doctor arrangement, and can adhere to the treatment and follow-up. sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Anemia or diabetes, and women who are breastfeeding or during pregnancy; 2. Patients with organic diseases or mental illness.

Design outcomes

Primary

MeasureTime frame
5-HT;GABA; Insomnia Severity Index;TCM Symptom Scale;NE;MLT;5-HIAA;Sleep rate;IL-6;DA;Pinsburgh Sleep Quality Index;IL-1;TNF;

Secondary

MeasureTime frame
Hamilton Anxiety Scale; Epworth somnolence scale; Hamilton Depression Scale;

Countries

China

Contacts

Public ContactGao Xiyan

Third Affiliated Hospital of He'nan University of Traditional Chinese Medicine

gaoxiyan@yeah.net+86 18703634802

Outcome results

None listed

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