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A Clinical Trail of Acupuncture and Herbs for Post-stroke Cogntive Impairment

T

The Third Affiliated hospital of Zhejiang Chinese Medical University

Status

Unknown

Conditions

Post-stroke Cognitive Impairment

Treatments

Combination Product: Chinese traditional rehabilitation

Study type

Interventional

Funder types

Other

Identifiers

NCT04596072
2020ZJZS002

Details and patient eligibility

About

The traditional Chinese medicine rehabilitation for the post-stroke cognitive impairment will be intervened, which can promote the recovery of post-stroke cognitive function patients, reduce the disability rate and improve the quality of life.

Full description

This study will collect inpatients from April 2020 to December 2022 who from the third affiliated hospital of Zhejiang university of traditional Chinese medicine, Jiaxing hospital of traditional Chinese medicine, Hangzhou hospital of traditional Chinese medicine.this study sets strict time window (stroke recovery, 30-180 days), use multi-center, large sample, randomized controlled study method and the objective recognition rehabilitation evaluation criteria and efficacy evaluation system to evaluate the clinical effect and analysis of health economics.

Enrollment

123 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

-Cognitive disorder

  • Chinese medicine diagnosed as apoplexy;
  • The diagnosis of cerebral infarction or cerebral hemorrhage was consistent with western medicine by CT/MRI examination;
  • The course of disease ranges from 30 to 180 days;
  • First onset; Or come on in the past without the sequela such as limb paralysis; ·Age ≥18 years;
  • Informed consent signed by the legal guardian of the patient;
  • Montreal cognitive assessment scale (Montreal Cognitive Assessment, MoCA) score reaches a certain standard, MoCA scale score of 30 points, scored 17-26 points or less judged with cognitive impairment, if the education time 12 years or less on the basis of plus 1;
  • Hamilton depression scale (HAMD) < 20.
  • Meet the requirements of indications of acupuncture and moxibustion; Volunteer to participate in this project, the patient has no serious complications, can accept acupuncture treatment and good compliance.

Exclusion criteria

  • Cognitive disorder

    • Subarachnoid hemorrhage, transient ischemic attack, or with other intracranial lesions such as intracranial tumor, aneurysm, vascular malformation, cysticercosis, schistosomiasis, encephalitis, meningitis, hydrocephalus, brain trauma sequelae; ·Non-atherosclerotic thrombotic cerebral infarction (such as cardiogenic embolism, clotting status, endovascular shedding, arteritis, etc.);
    • Patients with severe primary chronic diseases such as heart, liver, kidney, viscera, endocrine system, hematopoietic system, serious disorders of language understanding, and mental disorders;
    • Suffered from a variety of bleeding tendency diseases;
    • Pregnant or lactating women;
    • Patients who do not meet the inclusion criteria, do not have poor treatment compliance as prescribed, which cannot judge the efficacy or incomplete data affect the efficacy judgment and are not suitable for clinical observation.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

123 participants in 2 patient groups

control
No Intervention group
Description:
basic treatment+ Cognitive rehabilitation training
treatment
Experimental group
Description:
basic treatment+ Cognitive rehabilitation training+Chinese traditional rehabilitation
Treatment:
Combination Product: Chinese traditional rehabilitation

Trial contacts and locations

3

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Central trial contact

RUIJIE MA, Doctor; XINYUN LI, Master

Data sourced from clinicaltrials.gov

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