Post-stroke DysphagiaNCT07493902
Acupuncture for Post-Stroke Dysphagia: A Clinical Study
A study testing acupuncture in people with Post-stroke Dysphagia and Acupuncture, run by First Teaching Hospital of Tianjin University of Traditional Chinese Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Post-stroke Dysphagia, Acupuncture
- What is being tested?
- acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,232 participants
- Where
- 1 siteChina
- Study dates
- Apr 2026to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xiaonong Fan
Tianjin, Tianjin Municipality, 300193
Xiaonong Fan, PhD, 13902080823, fanxiaonong@163.com
About this study
Official title: Acupuncture Treatment for Post-Stroke Dysphagia: A Prospective, Multicenter Clinical Study of a Cohort-Based Embedded Partially Randomized Preference Trial
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 protocols generates high-level evidence through randomized cohorts while supplementing real-world decision-making with preference cohort data.
Read the 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 factor, naturally forming two cohorts. Primary efficacy outcomes will assess clinical efficacy of acupuncture interventions for PSD, clarify therapeutic advantages of precision acupuncture protocols, explore treatment benefits across PSD subgroups, and evaluate the efficacy and health economic value of diversified integrated Chinese-Western medical approaches to inform guideline updates with evidence-based data.
Study 2 (Embedded Study): Employing a prospective, multicenter, partially randomized preference study, we enrolled patients with post-stroke dysphagia meeting inclusion/exclusion criteria who visited the research center between January 2026 and December 2027. Acupuncture intervention grouping followed a "preference-priority, random-supplement" strategy. Specifically: Patients with clear preferences were assigned to their chosen group; those without preferences were randomized 1:1 to either the conventional acupuncture group or the "Tongguan Liqiao" acupuncture group. Swallowing function served as the primary efficacy indicator to evaluate the clinical efficacy of different acupuncture intervention protocols for treating PSD.
- Conditions
- Post-stroke Dysphagia, Acupuncture
- Being tested
- acupuncture
- Keywords
- post-stroke dysphagia, acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureProcedure or surgery
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/T12346-2006) "Acupoint Names and Locations." Manipulation follows the SCM 88-2025 International Standard for Traditional Chinese Medicine Techniques: Acupuncture Method for Tongguan Liqiao to Treat Post-Stroke Dysphagia.
Conventional Acupuncture Group： The "protocol scheme" habitually applied by each research unit (sub-center). Once designated, the protocol scheme shall not be altered and must be strictly adhered to.
| Study group | Role | What they receive |
|---|---|---|
| "Tongguan Liqiao" Acupuncture Group | Experimental | 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. Receives: Procedure: acupuncture |
| Conventional Acupuncture Group | Active comparator | 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. Receives: Procedure: acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Days 1-14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-stroke DysphagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study employs a nested design comprising two components. Study 1 (Main Cohort): A prospective, multicenter cohort study. Patients with post-stroke dysphagia enrolled from January 2026 to December 2027 will be stratified into an "acupuncture cohort" and a "non-acupuncture cohort" based on actual clinical exposure to acupuncture. Total enrollment: 3,232 patients. Study 2 (Nested Study): A prospective, multicenter, partially randomized preference trial nested within Study 1, targeting patients with explicit acupuncture preferences. It employs a "preference-priority, random-supplementation" strategy: Patients with clear preferences are enrolled in their chosen "conventional acupuncture" or "acupuncture for Tongguan Liqiao" group; patients without clear preferences are randomly assigned 1:1 to either group. Approximately 230 patients without clear preferences will be recruited.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 3,232 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuzheng Du, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07493902
- Sponsor's protocol ID
- TYLL2026[K]007
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture Treatment for Post-Stroke Dysphagia: A Prospective, Multicenter Clinical Study of a Cohort-Based Embedded Partially Randomized Preference Trial
- ClinicalTrials.gov ID
- NCT07493902
- Acronym / sponsor ID
- TYLL2026[K]007
- Conditions
- Post-stroke Dysphagia, Acupuncture
- Keywords
- post-stroke dysphagia, acupuncture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,232 participants (estimated)
- Lead sponsor
- First Teaching Hospital of Tianjin University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 25 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 protocols generates high-level evidence through randomized cohorts while supplementing real-world decision-making with preference cohort data.
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 factor, naturally forming two cohorts. Primary efficacy outcomes will assess clinical efficacy of acupuncture interventions for PSD, clarify therapeutic advantages of precision acupuncture protocols, explore treatment benefits across PSD subgroups, and evaluate the efficacy and health economic value of diversified integrated Chinese-Western medical approaches to inform guideline updates with evidence-based data.
Study 2 (Embedded Study): Employing a prospective, multicenter, partially randomized preference study, we enrolled patients with post-stroke dysphagia meeting inclusion/exclusion criteria who visited the research center between January 2026 and December 2027. Acupuncture intervention grouping followed a "preference-priority, random-supplement" strategy. Specifically: Patients with clear preferences were assigned to their chosen group; those without preferences were randomized 1:1 to either the conventional acupuncture group or the "Tongguan Liqiao" acupuncture group. Swallowing function served as the primary efficacy indicator to evaluate the clinical efficacy of different acupuncture intervention protocols for treating PSD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This study employs a nested design comprising two components. Study 1 (Main Cohort): A prospective, multicenter cohort study. Patients with post-stroke dysphagia enrolled from January 2026 to December 2027 will be stratified into an "acupuncture cohort" and a "non-acupuncture cohort" based on actual clinical exposure to acupuncture. Total enrollment: 3,232 patients. Study 2 (Nested Study): A prospective, multicenter, partially randomized preference trial nested within Study 1, targeting patients with explicit acupuncture preferences. It employs a "preference-priority, random-supplementation" strategy: Patients with clear preferences are enrolled in their chosen "conventional acupuncture" or "acupuncture for Tongguan Liqiao" group; patients without clear preferences are randomly assigned 1:1 to either group. Approximately 230 patients without clear preferences will be recruited.
| Arm | Type | Receives |
|---|---|---|
| "Tongguan Liqiao" Acupuncture Group | Experimental | Procedure: acupunctureThe 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. |
| Conventional Acupuncture Group | Active comparator | Procedure: acupunctureEach 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18 and 80 years old, no gender restrictions;
Key exclusion criteria (4 listed)
- Dysphagia not caused by stroke, but resulting from other neurological disorders (e.g., motor neuron disease, myasthenia gravis) or organic lesions (e.g., tumors);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupunctureTongguan 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/T12346-2006) "Acupoint Names and Locations." Manipulation follows the SCM 88-2025 International Standard for Traditional Chinese Medicine Techniques: Acupuncture Method for Tongguan Liqiao to Treat Post-Stroke Dysphagia. Conventional Acupuncture Group： The "protocol scheme" habitually applied by each research unit (sub-center). Once designated, the protocol scheme shall not be altered and must be strictly adhered to. | Procedure or surgery | "Tongguan Liqiao" Acupuncture Group, Conventional Acupuncture Group |
Primary outcome
Respondent proportion
Time frame: Days 1-14
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture in people with Post-stroke Dysphagia and Acupuncture, run by First Teaching Hospital of Tianjin University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respondent proportion (time frame: Days 1-14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.