Trial Radar IA | ||
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Lo studio clinico NCT07493902 per Post-stroke Dysphagia, Agopuntura è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
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Acupuncture for Post-Stroke Dysphagia: A Clinical Study 3.232 Randomizzato Dati real-world
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La sperimentazione clinica NCT07493902 è uno studio interventistico per Post-stroke Dysphagia, Agopuntura, attualmente in arruolamento. Avviato il 1 aprile 2026, prevede di arruolare 3.232 partecipanti. Sotto la guida di First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, dovrebbe concludersi entro il 1 aprile 2028. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 25 marzo 2026.
Sommario breve
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...Mostra di più
Descrizione dettagliata
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...
Mostra di piùTitolo ufficiale
Acupuncture Treatment for Post-Stroke Dysphagia: A Prospective, Multicenter Clinical Study of a Cohort-Based Embedded Partially Randomized Preference Trial
Patologie
Post-stroke DysphagiaAgopunturaAltri ID dello studio
- TYLL2026[K]007
Numero NCT
Data di inizio (effettiva)
2026-04
Ultimo aggiornamento pubblicato
2026-03-25
Data di completamento (stimata)
2028-04
Arruolamento (previsto)
3.232
Tipo di studio
Interventistico
FASE
N.D.
Stato
In arruolamento
Parole chiave
post-stroke dysphagia
acupuncture
acupuncture
Scopo principale
Trattamento
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Doppio
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
Sperimentale"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. | Agopuntura 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...Mostra di più |
Comparatore attivoConventional 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. | Agopuntura 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...Mostra di più |
Esito primario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
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 |
Assistente alla partecipazione
Criteri di eleggibilità
Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
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 MedicineParte responsabile dello studio
Yuzheng Du, Investigatore principale, Chief Physician, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Nessun dato di contatto
1 Centri dello studio in 1 paesi
Tianjin Municipality
Xiaonong Fan, Tianjin, Tianjin Municipality, 300193, China
Xiaonong Fan, PhD, Contatto, 13902080823, [email protected]
In arruolamento