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Clinical study and mechanism of treatment of insomnia after liver wind internal stroke by Nourishing blood and Softening liver acupuncture

Xingnao Kaiqiao acupuncture treatment of sleep disorders after stroke

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100005423
Enrollment
Unknown
Registered
2021-12-19
Start date
2017-10-01
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

Sleep disturbance after stroke

Interventions

experimental group:Nourishing blood and softening liver acupuncture

Sponsors

tianjin academy of traditional chinese medicine affiliated hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Meet the above-mentioned diagnostic criteria of Chinese and Western medicine for stroke and insomnia and the diagnostic criteria for syndromes; (2) No history of insomnia and use of various psychotropic drugs before stroke; (3) People who sleep less than 6 hours at night after a stroke, frequently wake up from sleep, or stay awake at night; more than 3 times a week for more than 1 month; (4) The Pittsburgh Sleep Quality Score (PSQI) exceeds 7 points; (5) During the recovery period from 15 days to 180 days after the onset of stroke; (6) Unconsciousness obstacles, no obvious intelligence, language understanding and expression obstacles, able to basically complete various scale tests independently; (7) NIHSS score = 15 points; (8) 45 years old = age = 80 years old; (9) Informed consent of patients. Those who meet the above criteria at the same time can be selected.

Exclusion criteria

Exclusion criteria: (1) Patients allergic to estazolam; (2) Insomnia caused by other diseases or living habits (alcoholism, drug dependence, etc.); or those who are dependent on tranquillizers; (3) Those with severe mental symptoms; (4) Those who have participated in clinical research of other drugs in the past month, or those who have used related psychosedatives in the past two weeks; (5) Severe heart, liver (ALT, AST exceeding 50% of the upper limit of normal), kidney (BUN exceeding 20% ??of the upper limit of normal, Cr exceeding the upper limit of normal), hematopoietic system and metabolic system and other serious diseases or other People with severe diseases in various systems; (6) Women who are breast-feeding, pregnant, or likely to become pregnant during the trial period; (7) Poor compliance after enrollment, privately combined use of drugs or treatments not permitted by the trial, serious adverse reactions during treatment, loss to follow-up or refusal to continue to participate in the trial. Those that meet one of the above will be excluded.

Design outcomes

Primary

MeasureTime frame
?-aminobutyric acid;5-hydroxytryptamine;Pittsburgh Sleep Quality Index;TCM Symptom Scale;Sleep rate;

Secondary

MeasureTime frame
Tumor necrosis factor-a;National Institutes of Health Stroke Scale;Safety Analysis;Ability index of daily living activities;Comparison of onset and maintenance time;Interleukin-6;

Countries

China

Contacts

Public ContactZhilong Zhao
zhangzhilongtj@163.com18222235269

Outcome results

None listed

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