Acute Ischemic Apoplexy Syndrome Specificity and Acupuncture Intervention Research

NCT ID: NCT04528472

Last Updated: 2020-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

194 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2022-10-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Acute Ischemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Acupuncture Treatment

Acupuncture Treatment: main point: DU20, DU24, MS7, LI4, ST40 Oral Medicine Rehabilitation Treatment

Group Type EXPERIMENTAL

Acupuncture Treatment

Intervention Type OTHER

stimulate acupoints to accelerate recovery

Regular Treatment

Acupuncture Treatment Oral Medicine Rehabilitation Treatment

Group Type EXPERIMENTAL

Regular Treatment

Intervention Type OTHER

Oral Medicine and Rehabilitation Treatment

Interventions

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Acupuncture Treatment

stimulate acupoints to accelerate recovery

Intervention Type OTHER

Regular Treatment

Oral Medicine and Rehabilitation Treatment

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai University of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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jian pei, doctor

Role: STUDY_DIRECTOR

Longhua Hospital

Central Contacts

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qinhui fu, doctor

Role: CONTACT

008613795396770

yijun zhan, master

Role: CONTACT

008602164385700 ext. 3534

Other Identifiers

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longhuaacup

Identifier Type: -

Identifier Source: org_study_id

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