Register Now
Log In
中文/English
About ITMCTR|Search Trials|About Us|News
Effects of inhaling SuHeXiang essential oil on cognitive function in elderly patients with amnestic mild cognitive impairment

Registration number：

ITMCTR2025000579

Date of Last Refreshed on：

2025-03-24

Date of Registration：

2025-03-24

Registration Status：

Retrospective registration

Public title：

Effects of inhaling SuHeXiang essential oil on cognitive function in elderly patients with amnestic mild cognitive impairment

English Acronym：

Scientific title：

Effect of Suhexiang sniffing on cognitive function in amnestic mild cognitive impairment

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

zhu Yufang

Study leader：

Chen Haiying

Applicant telephone：

17732822663

Study leader's telephone：

13930151996

Applicant Fax：

Study leader's fax：

Applicant E-mail：

499701022@qq.com

Study leader's E-mail：

hychen1964@163.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

Hebei Medical University 361 Zhongshan East Road Shijiazhuang City Hebei Province

Study leader's address：

Hebei Medical University 361 Zhongshan East Road Shijiazhuang City Hebei Province

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Hebei Medical University

Approved by ethic committee：

Approved No. of ethic committee：

2023004

Approved file of Ethical Committee：

View

Name of the ethic committee：

Medical Ethics Committee of Hebei Medical University

Date of approved by ethic committee：

2023/3/16 0:00:00

Contact Name of the ethic committee：

Gu Shuo

Contact Address of the ethic committee：

No. 361 Zhongshan East Road changan

Contact phone of the ethic committee：

0311-86266225

Contact email of the ethic committee：

ydyxll@126.com

Primary sponsor：

Hebei Medical University

Primary sponsor's address：

361 Zhongshan East Road Shijiazhuang City Hebei Province

Secondary sponsor：

Country：

China

Province：

Hebei Province

City：

Shijiazhuang City

Institution
hospital：

Hebei Medical University

Address：

365 Zhongshan East Road Shijiazhuang City

Source(s) of funding：

self-financing

Target disease：

amnestic mild cognitive impairment

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Others

Objectives of Study：

This study investigated the therapeutic benefits of inhalation of SuHeXiang essential oil on cognitive function in people with amnestic mild cognitive impairment (aMCI). The serum concentrations of brain-derived neurotrophic factor (BDNF) and homocysteine (Hcy) and indicators of quantitative electroencephalogram (qEEG) were used as the outcome indicators to evaluate the effect of inhaled SuHeXiang essential oil on cognitive function in aMCI patients. This study provides guidance for the use of aromatherapy to treat aMCI and prevent cognitive impairment in the elderly.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

According to the diagnostic criteria for aMCI proposed by Petersen in 2004: 1. Age ≥65 years old; 2. A history of memory impairment of ≥3 months confirmed by informed persons; 3. Have basically normal daily living ability (ADL≤22 points); 4. Clinical dementia rating (CDR) score 0.5 points; 5. Simple Mental State Examination Scale (MMSE) score < 27; 6. Normal olfactory function; Right-handed; 7. Subjects agree to join the experiment and sign the informed consent.

Exclusion criteria：

1. Alcohol or drug dependence within the past six months; 2. Combined with aphasia or severe visual impairment or hearing impairment; 3. Cognitive decline due to vascular factors or depression; 4. There are brain structural abnormalities that lead to cognitive impairment: such as congenital mental retardation brain trauma etc.

Study execute time：

From 2023-01-02

To      2023-06-30

Recruiting time：

From 2023-03-16

To      2023-03-30

Interventions：

30

Group：

Aromatherapy trial group

Sample size：

Intervention：

Sniffing was performed once for 30 minutes from 19 to 21 o 'clock every day for 12 weeks. Each time use an eyedropper to absorb the suhexiang essential oil put 3 drops in the center of a circular filter paper with a diameter of 7cm place the filter paper 3cm away from the subject's nose and breathe evenly.

Intervention code：

30

Group：

Control group

Sample size：

Intervention：

Sniffing was performed once for 30 minutes from 19 to 21 o 'clock every day for 12 weeks. Each time use an eyedropper to absorb pure water drop 3 drops in the center of a circular filter paper with a diameter of 7cm place the filter paper 3cm away from the subject's nose and breathe evenly.

Intervention code：

Total sample size ： 60

Countries of recruitment
and research settings：

Country：

China

Province：

Hebei Province

City：

Institution/hospital：

Shijiazhuang Changan district Zhiyin nursing home

Level of the institution：

first-order

Outcomes：

Outcome：

MoCA

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Hcy

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Quantitative electroencephalogram

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

BDNF

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

MMSE

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

blood

Tissue：

Fate of sample 

Destruction after use

Note：

Completed

68
Min age years
85
Max age years

Recruiting status：

Participant age：

Gender：

Both

Randomization Procedure (please state who generates the random number sequence and by what method)：

According to the basic principle of randomized controlled trial the subjects were randomized by coin toss and the control group was set up.

Blinding：

IPD sharing：

Yes

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Public raw data date: December 1, 2023. How: Via email, jiageluan@163.com

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Methods of data collection: Researchers were trained by professional neurologists. Before the intervention and 12 weeks after the intervention the researcher conducted a questionnaire survey in a state of emotional stability and kept the surrounding environment quiet. The researchers learn and practice the knowledge related to EEG examination in the EEG room of neurology department and are uniformly trained and guided by professional physicians. Eeg was monitored before and after 12 weeks of intervention. Before intervention and 12 weeks after intervention 5ml of fasting venous blood samples were collected by professional nurses in strict accordance with the operational norms of venous blood collection under aseptic operation and pro-coagulant collection vessels containing inert separation glue were used to monitor the levels of Hcy and BDNF.

Data Managemen Committee：

Not yet

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

back
Platform information
About ITMCTR
About Us
Register Trials
Frequently Asked Questions
Ethical Review
The public service
Search Trials
Join Us
ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above