Acute Ischemic Apoplexy Syndrome Specificity and Acupuncture Intervention Research

Acute Ischemia Clinical Trial

— AIAI  

Official title:

Longhua Hospital, Shanghai University of TCM

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04528472
• Other study ID #: longhuaacup
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: October 1, 2022

Study information

• Verified date: August 2020
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: qinhui fu, doctor
• Phone: 008613795396770
• Email: ff777315[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This project optimizes the TCM Symptoms and Symptoms Scale. A curative effect evaluation system of acupuncture in the treatment of acute ischemic stroke is formed to provide clinical evidence by the following indexes: neurological impairment, motor dysfunction, TCM Symptoms and Symptoms Scale, combined with the patients' head MRI, Plasma BDNF, MMP-9 and other biomarkers.

Description:

Based on the previous work, this project optimizes the TCM Symptoms and Symptoms Scale. Through the cohort study method, 194 patients with acute ischemic stroke were evaluated for neurological impairment, motor dysfunction, TCM Symptoms and Symptoms Scale, combined with the patients' head MRI. , Plasma BDNF, MMP-9 and other biomarkers, screen TCM syndromes related to stroke outcome indicators, and adopt targeted comprehensive acupuncture and moxibustion program intervention and follow-up to establish a stroke-specific intervention outcome prediction model with TCM characteristics. A curative effect evaluation system of acupuncture and moxibustion in the treatment of acute ischemic stroke is formed to provide clinical evidence.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 194
• Est. completion date: October 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

Inclusion Criteria:

• (1) It meets the diagnostic criteria in the "Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2014"; with the support of brain CT or MRI imaging examination, the vital signs are stable, the state of consciousness is clear, and the GCS>8 points; (2).Onset is less than 2 weeks; (3). There is no indication for thrombolysis, or the patient do not accept thrombolysis; (4). For moderate to severe patients, the National Institute of Health Stroke Scale (NIHSS) = 4 points;(5).Glasgow coma standard (GCS)>7 points;(6).No serious disability before admission, and modified Rankin Scale (mRS) = 3;(7). The patient himself or his immediate family members signed the informed consent form.

Exclusion Criteria:

• (1) Cerebral hemorrhage or subarachnoid hemorrhage; (2) Cerebellar and brainstem infarction (including lacunar infarction); (3) Cerebral herniation is formed upon admission; (4) Patients with severe heart, lung, liver, and kidney diseases; (5) Severe upper gastrointestinal bleeding occurred after the onset; (6) The patient has participated in other clinical trials within the past 3 months; (7) Patients with mental illness, or those with severe cognitive impairment (MMSE score =9 points) (8) Those with a pacemaker, a metal foreign body at the treatment site, or a severe bleeding tendency.

(9) The investigator believes that other diseases accompanied by the patient may interfere with the correct evaluation of neurological function, or participating in this trial may cause other complications in the patient.

Related Conditions & MeSH terms

• Acute Ischemia
• Ischemia

Intervention

Other:
• Acupuncture Treatment
stimulate acupoints to accelerate recovery
• Regular Treatment
Oral Medicine and Rehabilitation Treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai University of Traditional Chinese Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	CRP	acute ischemic biomarker	baseline ,4 weeks
Other	BDNF	acute ischemic biomarker	baseline ,4 weeks
Other	MMP-9	acute ischemic biomarker	baseline ,4 weeks
Primary	NIHSS SCALE	NIHSS was created by the National Institutes of Health and has good reliability and validity. It has been widely used to evaluate the severity and prognosis of stroke. The scale consists of consciousness, gaze, vision, facial paralysis, movement, sensation, mutual aid, language, neglect and other items, with a maximum score of 33 points.	4 weeks
Secondary	Stroke Scale of Traditional Chinese Medicine, SSTCM	SSTCM mainly includes two parts: TCM symptoms and tongue and pulse conditions. There are a total of 24 symptoms of TCM symptoms. According to their severity and impact on daily life, each item is scored into 4 grades, with 0 points for normal, 1 point for mild, 2 points for moderate, and 3 points for severe. Tongue and pulse conditions are only recorded and not scored. The total score is the sum of the scores of TCM symptoms in Part 1. The higher the score, the more severe the symptoms and the greater the impact on life.	4 weeks
Secondary	modified Barthel Index, mBI	The mBI scale is mainly used to evaluate the self-care ability of patients in daily life. It can be summarized as the patients' independent activities in an indoor environment, such as eating, dressing, and toileting, with a total of ten items. The score of each item is divided into 5 levels, the lowest is 1 and the highest is 5. The higher the level, the greater the independence, and the total score is 100 points.	4 weeks