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Traditional Chinese Medicine Compound (Xiaxi) and Clinical Outcomes of Patients with Chronic Insomnia in Pattern of Gallbladder Meridian of Foot-shaoyang:A Randomized Clinical Trial

Traditional Chinese Medicine Compound (Xiaxi) and Clinical Outcomes of Patients with Chronic Insomnia in Pattern of Gallbladder Meridian of Foot-shaoyang:A Randomized Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085379
Enrollment
Unknown
Registered
2024-06-06
Start date
2024-06-15
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

Chronic Insomnia

Interventions

experimental group:According to theory of midday-midnight flowing of qi-bloodpoint to calculate accurate time to take decoction(Xiaxi), once a day, each time 100ml, every 1 week to take 5 days for 4 c
control group:According to theory of midday-midnight flowing of qi-bloodpoint to calculate accurate time to take placebo, once a day, each time 100ml, every 1 week to take 5 days for 4 consecutive wee

Sponsors

Guangdong Provincial Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1)Be diagnosed as chronic insomnia according to the Diagnostic criteria for the third edition of the international classification of sleep disorders (ICSD-3) and the pattern of gallbladder meridian of foot-shaoyang at the same time. (2) 8 = Pittsburgh Sleep Quality Index = 21 . (3) Not limited to gender, aged 18-80 years old. (4) Sign informed consent.

Exclusion criteria

Exclusion criteria: (1) Patients with diseases that have not been effectively controlled or are severe, such as cardiac and cerebrovascular diseases, inflammatory diseases, tumors, acute and chronic infections. (2) Patients with clinical diagnosis of severe anxiety or severe depression, psychiatric patients. (3) Pregnant and lactating patients. (4) Patients who are involved in other clinical researchs. (5) Patients with clear external factors causing insomnia. (6) Patients who are allergic to alcohol.

Design outcomes

Primary

MeasureTime frame
Pittsburgh Sleep Quality Index ;

Secondary

MeasureTime frame
Fatigue Scale-14;Patient Health Questionnaire-9;7-tiem Generalized Anxiety Disorder Scale;Psychomotor Vigilance Task;Morningness-eveningness Questionnaire;MemTrax;

Countries

China

Contacts

Public ContactFuping Xu

Guangdong Provincial Hospital of Chinese Medicine

xufuping163@163.com+86 159 0204 2439

Outcome results

None listed

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