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Study on the clinical effects and brain function regulation mechanism of Baduanjin intervention for chronic insomnia

Study on the clinical effects and brain function regulation mechanism of Baduanjin intervention for chronic insomnia

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300069241
Enrollment
Unknown
Registered
2023-03-10
Start date
2023-03-12
Completion date
Unknown
Last updated
2024-03-18

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

Conditions

Chronic insomnia

Interventions

Sponsors

Shanghai Municipal Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. Inclusion criteria of experimental group: (1) Patients meeting the diagnostic criteria for chronic insomnia; (2) ISI scale score 8-21; (3) HAMD scale score <=14; (4) Aged between 20 and 55 years, no gender limit; (5) Routine blood and urine tests and liver and kidney function no abnormal; (6) Right-handed; (7) Agree and sign the informed consent. 2. Inclusion criteria of control group: (1) Patients without insomnia symptoms; (2) Do not suffer from related diseases that may cause insomnia; (3) Routine blood and urine tests and liver and kidney function no abnormal; (4) Those who agreed to maintain a normal sleep schedule and not engage in activities that may lead to chronic insomnia during the study; (5) Aged between 20 and 55 years, no gender limit.

Exclusion criteria

Exclusion criteria: 1. Exclusion criteria of experimental group: (1) Patients with obvious organic lesions; (2) Taking drugs that may affect the determination of results; (3) Severe pain that is sufficient to cause sleep disorders or diseases that may cause insomnia; (4) Pregnant or lactating women, drug addiction, heavy metal poisoning and other patients; (5) The presence of progressive diseases related to the onset and course of insomnia; (6) Patients with mental illness; (7) Night shift work. 2. Exclusion criteria for control group: (1) Patients with endocrine system diseases, motor system diseases, autoimmune diseases, infectious diseases, diabetes and other metabolic diseases, mental diseases; (2) Disobey the arrangers related to this study during the experiment.

Design outcomes

Primary

MeasureTime frame
Pittsburgh Sleep Quality Index;

Secondary

MeasureTime frame
Hyperarousal Scale;Isomnia Severity Index;Salivary Cortisol;Actigraphy;Resting-state functional magnetic resonance;Fatigue Scale-14;Hamilton Depression Scale;polysomnography;

Countries

China

Contacts

Public ContactYao Fei

Shanghai Municipal Hospital of Traditional Chinese Medicine

doctoryaofei@126.com+86 135 8597 5106

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026