the Clinical Effect of TCM Sniffing Therapy Combined With Electroacupuncture in PSCI
ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 70
SponsorHangzhou Medical College
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
(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.
Disqualifiers
(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.
Trial design
Design model
Parallel
Treatments tested in this trial
control
Dietary supplementDonepezil 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
Other interventionElectronuchal acupuncture
Smell therapy group treatment
Other interventionnasal suction intervention with volatile oil of Acorus calamus
Electronuchal acupuncture combined with smell and inhalation therapy group treatment
Other interventionOn the basis of electric nuchal acupuncture treatment, sniffing and inhalation therapy is given.
Sham stimulation
Other interventionIn the sham stimulation group, non-transdermal comfortable acupuncture will be used to make the patients experience a feeling similar to acupuncture.
Treatment groups
220 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: controlNo intervention 0 interventions
Group B: Electronuchal acupuncture group treatmentExperimental treatment 2 interventions
Group C: Smell therapy group treatmentExperimental treatment 2 interventions
Group D: The combined treatmentExperimental treatment 2 interventions
Group E: normalOther 1 intervention
Group F: Sham groupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
MoCA
Montreal Cognitive Assessment Scale
Time frame
0,4 weeks after the intervention, 8 weeks after the interventionSecondary outcomes
1
MMSE
Mini-Mental State Examination
Time frame
0,4 weeks after the intervention,8 weeks after the intervention2
MBI
Barthel index score
Time frame
0,4 weeks after the intervention,8 weeks after the intervention3
TCD
Transcranial Doppler examination
Time frame
0,4 weeks after the intervention4
Near-infrared functional imaging of the brain
Near-infrared functional imaging of the brain
Time frame
0,4 weeks after the interventionSponsors and contacts
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Source ClinicalTrials.gov