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Die klinische Studie NCT06313866 für Schlaganfall ist offene rekrutierung. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen. | ||
Eine Studie entspricht den Filterkriterien
Kartenansicht
the Clinical Effect of TCM Sniffing Therapy Combined With Electroacupuncture in PSCI 220
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT06313866 ist eine interventionsstudie zur Untersuchung von Schlaganfall und hat den Status offene rekrutierung. Die Studie startete am 1. April 2024 und soll 220 Teilnehmer aufnehmen. Durchgeführt von Hangzhou Medical College ist der Abschluss für 1. Juni 2025 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 20. Februar 2025 aktualisiert.
Kurzbeschreibung
The patients with cognitive impairment after stroke were divided into control group, electroacupuncture group, olfactory therapy group, electroacupuncture combined with olfactory therapy group, and sham group with 35 people in each group. After the end of the treatment, the clinical efficacy was evaluated.
Ausführliche Beschreibung
The patients with cognitive impairment after stroke were divided into control group, electroacupuncture group, olfactory therapy group, and electroacupuncture combined with olfactory therapy group, and sham group with 35 people in each group. All patients were treated with conventional drugs and general supportive treatment, and on the basis of this, the electroacupuncture group was given electroacupuncture treatment...Mehr anzeigen
Offizieller Titel
the Clinical Effect of TCM Sniffing Therapy Combined With Electroacupuncture in the Treatment of Cognitive Impairment After Stroke
Erkrankungen
SchlaganfallWeitere Studien-IDs
- 2024ZL368
NCT-Nummer
Studienbeginn (tatsächlich)
2024-04-01
Zuletzt aktualisiert
2025-02-20
Studienende (vorauss.)
2025-06-01
Geplante Rekrutierung
220
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Offene Rekrutierung
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Dreifach verblindet
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
Keine Interventioncontrol Donepezil hydrochloride was administered at 5 mg once a day (nightly) for 30 days without adverse reactions and then increased to 10 mg once a day (nightly) for 4 weeks. | Nicht zutreffend |
ExperimentellElectronuchal acupuncture group treatment Use the neck needle to take the Fengchi and Gongxue on both sides (1.5cm directly below Fengchi point). | KONTROLLE Donepezil hydrochloride was administered at 5 mg once a day (nightly) for 30 days without adverse reactions and then increased to 10 mg once a day (nightly) for 4 weeks. Electronuchal acupuncture group treatment Electronuchal acupuncture |
ExperimentellSmell therapy group treatment The volatile oil of Acorus calamus is packed in the sniffer. Smell at the sniffing end, breathe evenly, 5-10 minutes each time, 3-5 times a day, for a total of 4 weeks of treatment. | KONTROLLE Donepezil hydrochloride was administered at 5 mg once a day (nightly) for 30 days without adverse reactions and then increased to 10 mg once a day (nightly) for 4 weeks. Smell therapy group treatment nasal suction intervention with volatile oil of Acorus calamus |
ExperimentellThe combined treatment The electro-neuchal acupuncture combined with sniffing and suction therapy group is treated with sniffing and suction therapy on the basis of electro-neuchal acupuncture treatment. | KONTROLLE Donepezil hydrochloride was administered at 5 mg once a day (nightly) for 30 days without adverse reactions and then increased to 10 mg once a day (nightly) for 4 weeks. Electronuchal acupuncture combined with smell and inhalation therapy group treatment On the basis of electric nuchal acupuncture treatment, sniffing and inhalation therapy is given. |
Anderenormal The volatile oil of Acorus calamus is packed in the sniffer. Smell at the sniffing end, breathe evenly, 5-10 minutes each time, 3-5 times a day, for a total of 4 weeks of treatment. | Smell therapy group treatment nasal suction intervention with volatile oil of Acorus calamus |
Schein-VergleichspräparatSham group In the sham stimulation group, non-transdermal comfortable acupuncture will be used to make the patients experience a feeling similar to acupuncture. | Schein-Stimulation In the sham stimulation group, non-transdermal comfortable acupuncture will be used to make the patients experience a feeling similar to acupuncture. |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
MoCA | Montreal Cognitive Assessment Scale | 0,4 weeks after the intervention, 8 weeks after the intervention |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
MMSE | Mini-Mental State Examination | 0,4 weeks after the intervention,8 weeks after the intervention |
MBI | Barthel index score | 0,4 weeks after the intervention,8 weeks after the intervention |
TCD | Transcranial Doppler examination | 0,4 weeks after the intervention |
Near-infrared functional imaging of the brain | Near-infrared functional imaging of the brain | 0,4 weeks after the intervention |
Magnetic resonance scanning | Magnetic resonance scanning | 0,4 weeks after the intervention |
the State Trait Anxiety Inventory (STAI) | the State Trait Anxiety Inventory (STAI) | 0,4 weeks after the intervention |
Teilnahme-Assistent
Eignungskriterien
Zugelassene Altersgruppen
Kind, Erwachsene, Ältere Erwachsene
Zugelassene Geschlechter
Alle
- (1) Stroke as per the TCM definition, presenting symptoms include unilateral paresis or paralysis, sensory deficits, speech impairment, and hemianopsia. PSCI diagnosis involves clinically significant deficits in at least one cognitive domain and severe disruption of instrumental ADLs/ADLs.; (2) The scores on the MMSE scale must adhere to the following criteria: Less than 17 points for individuals with illiteracy, less than 20 points for those with primary school education, and less than 24 points for individuals with a middle school education or higher.; (3) Aged under 70 years; (4) No history of mental illness, clear consciousness, stable vital signs, and able to complete the scale assessment; (5) Within 6 months post-stroke, diagnosed as a patient in the recovery period of cerebral infarction (or cerebral hemorrhage) at admission; (6) Signed informed consent by the patient or their family.
- (1) Transient ischemic attack; (2) Subarachnoid hemorrhage; (3) History of severe liver or kidney diseases, mental illness, epilepsy, asthma, or obstructive pulmonary diseases; (4) Occurrence of cognitive impairment prior to stroke; (5) Severe communication barriers; (6) Substance abuse or heavy alcohol consumption; (7) Implanted cardiac pacemakers or other electronic devices.
Hangzhou Medical CollegeZentrale Studienkontakte
Kontakt: Xinyun Dr LI, Doctor, 8618069783240, [email protected]
1 Studienstandorte in 1 Ländern
Zhejiang
the Affiliated Zhejiang Provincial People's Hospital to Hangzhou Medical College., Hangzhou, Zhejiang, 311000, China
Xinyun Dr LI, Doctor, Kontakt, 8618069783240, [email protected]
Offene Rekrutierung