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Participate in the clinical trial study of nighttime to improve sleep quality in middle-aged and elderly insomniacs

Participate in the clinical trial study of nighttime to improve sleep quality in middle-aged and elderly insomniacs

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200064211
Enrollment
Unknown
Registered
2022-09-30
Start date
2022-09-30
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

insomnia

Interventions

Experimental group:Participate in the night good night white film + black film
Control group 1:Simulating agent + black tablets
Control group 2:Synthetic + melatonin

Sponsors

The Affiliated Hospital of Changchun University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age >= 45 years old, meet the diagnostic criteria for chronic insomnia disorders; 2. Pittsburgh Sleep Quality Scale score >= 7 points; 3. Interested in ginseng products; 4. Be able to understand the sleep diary, be willing to fill in the sleep diary and commit to other procedures required by the research program; 5. Have sufficient cognitive ability to sign an informed consent form

Exclusion criteria

Exclusion criteria: 1. Patients diagnosed with anxiety and depression by the Anxiety and Depression Scale; 2. Accompanied by serious underlying diseases affecting survival, including uncontrolled and clinically significant heart, lung, kidney, digestive, blood diseases, neurological diseases, immune diseases, metabolic diseases, malignant tumors, severe malnutrition, etc.; 3. Allergic constitution, allergic to the products involved in the treatment plan; 4. According to the judgment of the researchers, it is not suitable for the use of the products involved in the treatment plan, such as the body is prone to inflammatory reactions; 5. Pregnant or lactating women; 6. Those whose mental state cannot be cooperated, who suffer from mental illness, who have no self-awareness, and who cannot express themselves clearly; 7. Those who are participating in other clinical trials; According to the investigators, there will be complications in enrollment or poor compliance in patients who affect the efficacy and safety assessment

Design outcomes

Primary

MeasureTime frame
PSQI;ActiGraph motion;

Secondary

MeasureTime frame
DNA methylation;Brain-derived nerve growth factor in serum;C-reactive protein;? neurotransmitters such as aminobutyric acid;Blood routine;Urinalysis;Liver and kidney function;

Countries

China

Contacts

Public ContactJixiang Ren

The Affiliated Hospital of Changchun University of Traditional Chinese Medicine

renjx2003@163.com+86 13604324381

Outcome results

None listed

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