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Construction of clinical research database of ''Tongguan Liqiao'' acupuncture and study of its effect mechanism under the guidance of traditional Chinese medicine academic thought inheritance model

Construction of clinical research database of ''Tongguan Liqiao'' acupuncture and study of its effect mechanism under the guidance of traditional Chinese medicine academic thought inheritance model

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071266
Enrollment
Unknown
Registered
2023-05-09
Start date
2021-06-01
Completion date
Unknown
Last updated
2023-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-stroke dysphagia, PSD

Interventions

acupuncture group:acupuncture
sham acupuncture group:sham acupuncture
waiting-list group:no acupuncture treatment, receiving compensation acupuncture for two weeks after the end of the observation cycle
healthy control group:none

Sponsors

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Inclusion criteria for ischemic stroke patients with pseudobulbar paralysis: (1) Meet the diagnostic criteria for acute ischemic stroke in the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018 and the diagnostic criteria for dysphagia disorders (the diagnostic criteria for the Treatment of Stroke Patients: Identification and Treatment of dysphagia in the National Clinical Guidelines for Stroke written by the Scottish College Guidelines Collaboration Group); (2) Aged 18-80 years; (3) Functional oral feeding (FOIS) score 2-5; (4) 30 days <= duration <=160 days; (5) The infarct was located in the cerebral cortex; (6) The patient or legal representative gives informed consent and signs the informed consent. 2. Inclusion criteria for health controls: (1) From community recruitment; (2) Gender and age matched with the experimental group; (3) No history of stroke, diabetes, hypertension, hyperlipidemia, coronary heart disease, etc.; (4) No history of smoking or drinking; (5) The National Institute of Health Stroke Scale (NHISS) assessed the degree of neurological impairment <=1 score; (6) No responsible lesions were determined by brain CT or MRI.

Exclusion criteria

Exclusion criteria: Exclusion criteria for ischemic stroke patients with pseudobulbar paralysis: 1. Patients with dysphagia disorder before the onset of the disease; 2. Suffering from other life-threatening serious diseases with an expected survival time of less than 3 months; 3. Unable to complete the study due to mental illness, cognitive or emotional disorders; 4. Patients with severe needle fainting intolerance; 5. Unable to complete the swallowing function assessment; 6. Patients who are pregnant, planning pregnancy or breastfeeding; 7. Patients who have participated in other drug clinical trials in the past 1 month.

Design outcomes

Primary

MeasureTime frame
Functional Oral Intake Scale (FOIS);

Secondary

MeasureTime frame
Functional connection (FC);Regional homogeneity (ReHo);Amplitude of low (ALFF);Standardized Swallowing Assessment (SSA);Body mass index (BMI);Edinburgh Handedness Inventory(EHI);Self-Rating Anxiety Scale (SAS);Self-Rating Depression Scale (SDS);Massachusetts Hospital Acupuncture Sensory Scale (MASS);

Countries

China

Contacts

Public ContactFan Xiaonong

The First Affiliated Hospital of Tianjin University of Chinese Medicine

344164606@qq.com+86 139 0208 0823

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026