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RecruitingNCT06313866Updated Feb 20, 2025

the Clinical Effect of TCM Sniffing Therapy Combined With Electroacupuncture in PSCI

An interventional study of control and Electronuchal acupuncture group treatment in Stroke, sponsored by Hangzhou Medical College. Recruiting at 1 site in China. Open to participants aged Up to 70 Years. Per ClinicalTrials.gov, last updated 2025-02-20.

Sponsored by Hangzhou Medical College · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2025, 1 year 6 months ago, but the record still lists the study as recruiting.
  • Started Apr 2024; still recruiting 2 years 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
220
Allocation
Randomized
Ages
Up to 70 Years
Sex
All
01

Study 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.

Read the detailed description

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 at bilateral Fengchi and Gongxue, the smell suction therapy group was given the intervention of volatile oil nasal suction of Acorus calamus, and the electroacupuncture group combined with smell and suction therapy group was given electroacupuncture treatment at the same time as the electroacupuncture treatment of bilateral Fengchi and Gongxue. In the sham stimulation group, non-transdermal comfortable acupuncture will be used to make the patients experience a feeling similar to acupuncture. After the 1 month innervation,the main efficacy indicators: Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), Barthel Index (MBI) score, and the secondary efficacy indicators: Transcranial Doppler (TCD), near-infrared functional brain imaging , magnetic resonance examination, the heart rate,blood pressure and the State Trait Anxiety Inventory (STAI)are collected.

02

Conditions studied

  • Stroke

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03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's planned enrollment of 220 is above the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Hangzhou Medical College is the lead sponsor of 3 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • (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.

Exclusion criteria

Exclusion Criteria:

  • (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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
220 participants (estimated)

Study arms

  • No intervention
    control

    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.

  • Experimental
    Electronuchal acupuncture group treatment

    Use the neck needle to take the Fengchi and Gongxue on both sides (1.5cm directly below Fengchi point).

    Dietary Supplement: control · Other: Electronuchal acupuncture group treatment

  • Experimental
    Smell 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.

    Dietary Supplement: control · Other: Smell therapy group treatment

  • Experimental
    The 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.

    Dietary Supplement: control · Other: Electronuchal acupuncture combined with smell and inhalation therapy group treatment

  • Other
    normal

    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.

    Other: Smell therapy group treatment

  • Sham comparator
    Sham group

    In the sham stimulation group, non-transdermal comfortable acupuncture will be used to make the patients experience a feeling similar to acupuncture.

    Other: Sham stimulation

Interventions

  • Dietary supplementcontrol

    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.

  • OtherElectronuchal acupuncture group treatment

    Electronuchal acupuncture

  • OtherSmell therapy group treatment

    nasal suction intervention with volatile oil of Acorus calamus

  • OtherElectronuchal acupuncture combined with smell and inhalation therapy group treatment

    On the basis of electric nuchal acupuncture treatment, sniffing and inhalation therapy is given.

  • OtherSham stimulation

    In the sham stimulation group, non-transdermal comfortable acupuncture will be used to make the patients experience a feeling similar to acupuncture.

06

What researchers measure

Primary outcomes

  1. MoCA

    Montreal Cognitive Assessment Scale

    Time frame: 0,4 weeks after the intervention, 8 weeks after the intervention

Secondary outcomes

  1. MMSE

    Mini-Mental State Examination

    Time frame: 0,4 weeks after the intervention,8 weeks after the intervention

  2. MBI

    Barthel index score

    Time frame: 0,4 weeks after the intervention,8 weeks after the intervention

  3. TCD

    Transcranial Doppler examination

    Time frame: 0,4 weeks after the intervention

  4. Near-infrared functional imaging of the brain

    Near-infrared functional imaging of the brain

    Time frame: 0,4 weeks after the intervention

  5. Magnetic resonance scanning

    Magnetic resonance scanning

    Time frame: 0,4 weeks after the intervention

  6. the State Trait Anxiety Inventory (STAI)

    the State Trait Anxiety Inventory (STAI)

    Time frame: 0,4 weeks after the intervention

07

Study locations

1 of 1 sites recruiting
  • the Affiliated Zhejiang Provincial People's Hospital to Hangzhou Medical College.
    Hangzhou, Zhejiang 311000, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06313866
Lead sponsor
Hangzhou Medical College
Responsible party
Sponsor
First posted
Mar 15, 2024
Start date
Apr 1, 2024
Primary completion
Apr 1, 2025 (estimated)
Completion
Jun 1, 2025 (estimated)
Last update
Feb 20, 2025

Study contacts

Xinyun Dr LI, Doctor
Contact
lxyjasmine2010@163.com
8618069783240
Xinyun Li, doctor
principal investigator · hangzhou medical colleage

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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