Post-stroke Sleep Disorders
Conditions
Interventions
Acupuncture group:Xingnao Kaiqiao Acupuncture+Yangxue Rougan Acupuncture+Basic treatment+Placebo (estazolam tablets)
Control group:Conventional acupuncture treatment+Basic treatment+Estazolam tablets
Sponsors
Tianjin Academy of Traditional Chinese Medcine Affiliated Hospital
Eligibility
Sex/Gender
All
Age
45 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Individuals who meet the diagnostic criteria of stroke and sleep disorders; 2. Individuals who suffered first stroke, and no sleep disorder, no obvious intelligence, language understanding and expression barrier before onset of stroke, and can basically complete various scale evaluation; 3. Individuals between the ages of 45 and 80 years; 4. The Pittsburgh Sleep Quality Index(PSQI) scored more than seven points; 5. Individuals between 15 to 180 days after onset of stroke; 6. Individuals who less than six hours of night sleep, and frequent awakening or sleepless nights after stroke, and last more than three times a week for more than a month; 7. Individuals who voluntarily agree with a study protocol and sign a written informed consent; Individuals, who meet the both above seven criteria, were selected.
Exclusion criteria
Exclusion criteria: 1. Individuals who not conforming to the diagnosis and inclusion criteria; 2. Individuals were allergic to estazolam; 3. Patients with vascular dementia and severe aphasia were not able to carry out the questionnaire; 4. Sleep disorders caused by drugs or alcohol. Alcoholism or drug dependence (such as long-term treatment of antipsychotic drugs, etc.); 5. Severe mental symptoms. Sleep disorders caused by physical or other mental illness; 6. Other clinical drug researches participated in the past one month, or mental sedatives used in two weeks; 7. Individuals who have severe diseases, such as severe heart, liver(ALT, AST is 50% above the normal limit), kidney(the BUN exceeds the normal limit of 20%, and the Cr exceeds the normal limit range), hematopoietic system and metabolic system, or severe other systerm diseases; 8. Pregnancy, planning a pregnancy or breast-feeding; 9. The use of drugs or treatments that prohibit, or refusal to continue to participate in the test; If one of the above-mentioned items is met, individuals who will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleep rate;Pittsburgh Sleep Quality Index,PSQI;TCM Symptom Scale;Inflammatory factors IL-6;Inflammatory factors IL-8;Inflammatory factors TNF-a; | — |
Secondary
| Measure | Time frame |
|---|---|
| blood routine;urine routine;stool routine;Liver Function(aspartate transaminase,AST;alanine aminotransferase,ALT);Renal Function(blood urea nitrogen,BUN;serum creatinine,Cr);NIH Stroke Scale(NHISS);Activities of Daily Living Scale(ADL); | — |
Countries
China
Contacts
Public ContactZhang Zhilong
Tianjin Academy of Traditional Chinese Medcine Affiliated Hospital
Outcome results
None listed