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

Phase 1

Completed

• Conditions: Sleep disturbance after stroke

• Registration Number: ITMCTR2100005423
• Lead Sponsor: tianjin academy of traditional chinese medicine affiliated hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-02-20

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: Not specified

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

(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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified