the Clinical Effect of TCM Sniffing Therapy Combined With Electroacupuncture in PSCI
1 other identifier
interventional
220
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable stroke
Started Apr 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 10, 2024
CompletedFirst Posted
Study publicly available on registry
March 15, 2024
CompletedStudy Start
First participant enrolled
April 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2025
CompletedFebruary 20, 2025
November 1, 2024
1 year
March 10, 2024
February 19, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
MoCA
Montreal Cognitive Assessment Scale
0,4 weeks after the intervention, 8 weeks after the intervention
Secondary Outcomes (6)
MMSE
0,4 weeks after the intervention,8 weeks after the intervention
MBI
0,4 weeks after the intervention,8 weeks after the intervention
TCD
0,4 weeks after the intervention
Near-infrared functional imaging of the brain
0,4 weeks after the intervention
Magnetic resonance scanning
0,4 weeks after the intervention
- +1 more secondary outcomes
Study Arms (6)
control
NO INTERVENTIONDonepezil 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
EXPERIMENTALUse the neck needle to take the Fengchi and Gongxue on both sides (1.5cm directly below Fengchi point).
Smell therapy group treatment
EXPERIMENTALThe 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.
The combined treatment
EXPERIMENTALThe 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.
normal
OTHERThe 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.
Sham group
SHAM COMPARATORIn the sham stimulation group, non-transdermal comfortable acupuncture will be used to make the patients experience a feeling similar to acupuncture.
Interventions
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
nasal suction intervention with volatile oil of Acorus calamus
On the basis of electric nuchal acupuncture treatment, sniffing and inhalation therapy is given.
In the sham stimulation group, non-transdermal comfortable acupuncture will be used to make the patients experience a feeling similar to acupuncture.
Eligibility Criteria
You may qualify if:
- (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.
You may not qualify if:
- (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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
the Affiliated Zhejiang Provincial People's Hospital to Hangzhou Medical College.
Hangzhou, Zhejiang, 311000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xinyun Li, doctor
hangzhou medical colleage
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 10, 2024
First Posted
March 15, 2024
Study Start
April 1, 2024
Primary Completion
April 1, 2025
Study Completion
June 1, 2025
Last Updated
February 20, 2025
Record last verified: 2024-11