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Clinical Trial NCT07493902 for Post-stroke Dysphagia, Acupuncture is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Acupuncture for Post-Stroke Dysphagia: A Clinical Study 3,232 Randomized Real-World Evidence

Recruiting
Clinical Trial NCT07493902 is an interventional study for Post-stroke Dysphagia, Acupuncture that is recruiting. It started on April 1, 2026 with plans to enroll 3,232 participants. Led by First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, it is expected to complete by April 1, 2028. The latest data from ClinicalTrials.gov was last updated on March 25, 2026.
Brief Summary
Employing a nested design, a partially randomized preference study (Study II) is embedded within a prospective, multicenter cohort study (Study I). The cohort study, with acupuncture as the exposure factor, explores the clinical efficacy and health economic value of different integrated Chinese and Western medicine treatment protocols. The nested partially randomized preference study of different acupuncture protocol...Show More
Detailed Description
A nested design was employed, incorporating a partially randomized preference study (Study 2) within a prospective, multicenter cohort study (Study 1).

Study 1 (Main Cohort): A prospective, multicenter cohort study will enroll patients with post-stroke dysphagia meeting inclusion and exclusion criteria who present at the research center between January 2026 and December 2027. Acupuncture will serve as the exposure f...

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Official Title

Acupuncture Treatment for Post-Stroke Dysphagia: A Prospective, Multicenter Clinical Study of a Cohort-Based Embedded Partially Randomized Preference Trial

Conditions
Post-stroke Dysphagiaacupuncture
Other Study IDs
  • TYLL2026[K]007
NCT ID Number
NCT07493902
Start Date (Actual)
2026-04
Last Update Posted
2026-03-25
Completion Date (Estimated)
2028-04
Enrollment (Estimated)
3,232
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
post-stroke dysphagia
acupuncture
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Experimental"Tongguan Liqiao" Acupuncture Group
The Tongguan Liqiao acupuncture technique developed by Academician Xuemin Shi is employed. The procedure follows the SCM 88-2025 International Standard for Traditional Chinese Medicine Techniques: Tongguan Liqiao Acupuncture for PSD.
acupuncture
Tongguan Liqiao Acupuncture Group： ①Acupoint Selection The treatment is phased, combining main and adjunct points. Main points: Neiguan (PC6), Shuigou (GV26), Sanyinjiao (SP6). Adjunct points: Fengchi (GB20), Wangu (GB12), Yifeng (TE17). Treatment is phased, combining primary and auxiliary points. ② Location and Operation Point locations follow the 2006 National Standard of the People's Republic of China (GB/T12346...Show More
Active ComparatorConventional Acupuncture Group
Each research unit (sub-center) shall strictly adhere to the "protocol plan" designated for routine use. Once specified, the protocol plan shall not be altered and must be executed in strict accordance with its provisions.
acupuncture
Tongguan Liqiao Acupuncture Group： ①Acupoint Selection The treatment is phased, combining main and adjunct points. Main points: Neiguan (PC6), Shuigou (GV26), Sanyinjiao (SP6). Adjunct points: Fengchi (GB20), Wangu (GB12), Yifeng (TE17). Treatment is phased, combining primary and auxiliary points. ② Location and Operation Point locations follow the 2006 National Standard of the People's Republic of China (GB/T12346...Show More
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Respondent proportion
Collect FOIS grading data at multiple time points. Proportion of patients showing an improvement of 2 grades or more in FOIS from baseline after treatment.
Days 1-14
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All

  • Age between 18 and 80 years old, no gender restrictions;

    • Meets diagnostic criteria for ischemic or hemorrhagic stroke, confirmed by CT or MRI, with disease duration within one year;

      • Meets diagnostic criteria for dysphagia, with FOIS grade 2-4;

        • Vital signs stable, able to understand and cooperate with study procedures; ⑤ Patient or legal representative agrees to sign informed consent.

  • Dysphagia not caused by stroke, but resulting from other neurological disorders (e.g., motor neuron disease, myasthenia gravis) or organic lesions (e.g., tumors);

    • Patients with psychiatric disorders or severe cognitive impairment who cannot cooperate with treatment;

      • Patients with an expected survival time of less than 3 months; ④ Individuals with contrast medium allergy;

        • Patients with severe needle phobia who cannot tolerate the procedure; ⑥ Pregnant women, those planning pregnancy, or lactating women; ⑦ Individuals who have participated in other clinical trials or received acupuncture within the past week.
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine logoFirst Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Study Responsible Party
Yuzheng Du, Principal Investigator, Chief Physician, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
No contact data.
1 Study Locations in 1 Countries

Tianjin Municipality

Xiaonong Fan, Tianjin, Tianjin Municipality, 300193, China
Xiaonong Fan, PhD, Contact, 13902080823, [email protected]
Recruiting