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the Clinical Effect of TCM Sniffing Therapy Combined With Electroacupuncture in PSCI 220
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT06313866 é um estudo intervencionista para Acidente vascular cerebral. Seu status atual é: em recrutamento. O estudo começou em 1 de abril de 2024 e pretende incluir 220 participantes. Coordenado por Hangzhou Medical College e deve ser concluído em 1 de junho de 2025. Essas informações foram atualizadas no ClinicalTrials.gov em 20 de fevereiro de 2025.
Resumo
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.
Descrição detalhada
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...Mostrar mais
Título oficial
the Clinical Effect of TCM Sniffing Therapy Combined With Electroacupuncture in the Treatment of Cognitive Impairment After Stroke
Condições médicas
Acidente vascular cerebralOutros IDs do estudo
- 2024ZL368
Número NCT
Data de início (real)
2024-04-01
Última atualização postada
2025-02-20
Data de conclusão (estimada)
2025-06-01
Inscrição (estimada)
220
Tipo de estudo
Intervencionista
FASE
N/A
Status
Em recrutamento
Propósito principal
Tratamento
Alocação do design
Randomizado
Modelo de intervenção
Paralelo
Cegamento (Mascaramento)
Triplo-cego
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
Nenhuma intervençãocontrol 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. | N/A |
ExperimentalElectronuchal acupuncture group treatment Use the neck needle to take the Fengchi and Gongxue on both sides (1.5cm directly below Fengchi point). | CONTROLE 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 |
ExperimentalSmell 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. | CONTROLE 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 |
ExperimentalThe 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. | CONTROLE 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. |
Outronormal 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 |
Comparador simuladoSham group In the sham stimulation group, non-transdermal comfortable acupuncture will be used to make the patients experience a feeling similar to acupuncture. | Estimulação simulada In the sham stimulation group, non-transdermal comfortable acupuncture will be used to make the patients experience a feeling similar to acupuncture. |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
MoCA | Montreal Cognitive Assessment Scale | 0,4 weeks after the intervention, 8 weeks after the intervention |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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 |
Assistente de participação
Critérios de elegibilidade
Idades elegíveis
Criança, Adulto, Idoso
Sexos elegíveis
Todos
- (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 CollegeContato central do estudo
Contato: Xinyun Dr LI, Doctor, 8618069783240, [email protected]
1 Locais do estudo em 1 países
Zhejiang
the Affiliated Zhejiang Provincial People's Hospital to Hangzhou Medical College., Hangzhou, Zhejiang, 311000, China
Xinyun Dr LI, Doctor, Contato, 8618069783240, [email protected]
Em recrutamento