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Basic research on the application of Zhuang medicinal oil combined with medicated thread moxibustion to mediate oxidative stress in the prevention and treatment of MCI based on TRPV1

Registration number：

ITMCTR2024000746

Date of Last Refreshed on：

2024-11-27

Date of Registration：

2024-11-27

Registration Status：

Retrospective registration

Public title：

Basic research on the application of Zhuang medicinal oil combined with medicated thread moxibustion to mediate oxidative stress in the prevention and treatment of MCI based on TRPV1

English Acronym：

Scientific title：

Basic research on the application of Zhuang medicinal oil combined with medicated thread moxibustion to mediate oxidative stress in the prevention and treatment of MCI based on TRPV1

Scientific title acronym：

Study subject ID：

2023GXNSFAA026094

The registration number of the Partner Registry or other register：

Applicant：

Huang Xin ge

Study leader：

Zhao Li hua

Applicant telephone：

13878129010

Study leader's telephone：

13006913108

Applicant Fax：

Study leader's fax：

Applicant E-mail：

511937296@qq.com

Study leader's E-mail：

zhaolh67@163.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

181 Mingxiu dong Road Nanning Guangxi China

Study leader's address：

181 Mingxiu dong Road Nanning Guangxi China

Applicant postcode：

Study leader's postcode：

Applicant's institution：

First Affiliated Hospital Guangxi University of Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

2023-060-02

Approved file of Ethical Committee：

View

Name of the ethic committee：

IEC for the First Affiliated Hospital of Guangxi University of Chinese Medicine

Date of approved by ethic committee：

2023/12/26 0:00:00

Contact Name of the ethic committee：

Li Junhong

Contact Address of the ethic committee：

Dongge Road & 89-9 Nanning 530023 China

Contact phone of the ethic committee：

+86 07715623553

Contact email of the ethic committee：

lijh1216@gxtcmu.com

Primary sponsor：

the First Affiliated Hospital of Guangxi University of Chinese Medicine

Primary sponsor's address：

Dongge Road & 89-9 Nanning 530023 China

Secondary sponsor：

Country：

China

Province：

Guangxi

City：

Nanning

Institution
hospital：

the First Affiliated Hospital of Guangxi University of Chinese Medicine

Address：

Dongge Road & 89-9, Nanning 530023, China

Source(s) of funding：

Guangxi Natural Science Foundation

Target disease：

mild cognitive impairment

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Others

Objectives of Study：

(1) Construct a key technical solution for strengthening medicinal oil combined with medicated thread moxibustion to mediate oxidative stress to prevent and treat MCI-prone constitutions and provide strong medicinal oil combined with medicated thread moxibustion for early diagnosis and treatment of MCI and prevention and treatment of AD. Standardization of diagnostic and treatment protocols to mediate oxidative stress regulation. (2) Promote and apply the technology of this project in more than 3 traditional Chinese medicine hospitals and community hospitals to improve the medical level of Zhuang medical technology in the prevention and treatment of MCI in the region.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

1: Patients who meet the diagnostic criteria for MCI; 2: There is memory impairment (self-reported and confirmed by an insider) MMSE score is between 24-27; 3: Age 55-75 years old; 4: Other cognitive functions are relatively normal or mildly impaired; 5: Daily life ability and social occupation are not affected; 6: The memory impairment has not yet reached the diagnostic criteria for dementia; 7: Exclude any other systemic diseases that can cause brain dysfunction; 8: The subject or guardian signs the informed consent form

Exclusion criteria：

1: Exclude subjective cognitive decline SCD and dementia; 2: Other neurological diseases other than suspected early-stage AD that can lead to cognitive decline such as Parkinson's disease vascular dementia brain tumors etc; 3: People with severe heart liver kidney and other systemic diseases such as insufficiency and other systemic diseases that can cause cognitive decline such as thyroid dysfunction anemia hepatic encephalopathy renal encephalopathy etc; 4: Those with abnormal brain structures such as intellectual development disabilities brain infections cerebral infarction cerebral hemorrhage and those with a history of severe head trauma or other diseases involving the central nervous system thus affecting the evaluation of neuropsychological scales; 5: Have a history of depression anxiety bipolar disorder schizophrenia and other mental illnesses; 6: Patients who have used other drugs that may cause changes in cognitive function or failure of important organs such as heart brain and kidne

Study execute time：

From 2023-06-01

To      2026-05-31

Recruiting time：

From 2023-12-27

To      2025-12-31

Interventions：

30

Group：

Non-MCI healthy control group

Sample size：

Intervention：

none

Intervention code：

31

Group：

Health education control group

Sample size：

Intervention：

Health education

Intervention code：

31

Group：

Zhuang medicine oil combined with medicine line moxibustion group

Sample size：

Intervention：

Zhuang medicine oil combined with medicine line moxibustion

Intervention code：

Total sample size ： 92

Countries of recruitment
and research settings：

Country：

China

Province：

Guangxi

City：

Nanning

Institution/hospital：

the First Affiliated Hospital of Guangxi University of Chinese Medicine

Level of the institution：

Tertiary-Hospital

Outcomes：

Outcome：

Animal fluency test ( AFT)

Type：

Secondary indicator

Measure time point of outcome：

baseline, the 3rd month, the 6th month

Measure method：

using Animal fluency test ( AFT)

Outcome：

Mini-mental state examination (MMSE)

Type：

Secondary indicator

Measure time point of outcome：

baseline, the 3rd month, the 6th month

Measure method：

using Mini-mental state examination (MMSE)

Outcome：

Montreal cognitive assessment(MoCA)

Type：

Primary indicator

Measure time point of outcome：

baseline, the 3rd month, the 6th month

Measure method：

using Montreal cognitive assessment(MoCA)

Outcome：

auditory verbal learning test-Huashan version (AVLT-H)

Type：

Secondary indicator

Measure time point of outcome：

baseline, the 3rd month, the 6th month

Measure method：

using auditory verbal learning test-Huashan version (AVLT-H)

Outcome：

Shape trails test A(STT-A)/shape trails test B(STT-B)

Type：

Secondary indicator

Measure time point of outcome：

baseline, the 3rd month, the 6th month

Measure method：

using Shape trails test A(STT-A)/shape trails test B(STT-B)

Outcome：

Functional Activities Questionnaire(FAQ)

Type：

Secondary indicator

Measure time point of outcome：

baseline, the 3rd month, the 6th month

Measure method：

using Functional Activities Questionnaire(FAQ)

Outcome：

Pittsburgh sleep quality index(PSQI)

Type：

Additional indicator

Measure time point of outcome：

baseline, the 3rd month, the 6th month

Measure method：

using Pittsburgh sleep quality index(PSQI)

Outcome：

Serum Aβ1-42, Tau and P-tau, BDNF levels

Type：

Secondary indicator

Measure time point of outcome：

baseline, the 3rd month, the 6th month

Measure method：

Enzyme-Linked Immunosorbent Assay （ELISA）

Outcome：

Short form of the World Health Organization Quality of Life Measurement Scale

Type：

Additional indicator

Measure time point of outcome：

baseline, the 3rd month, the 6th month

Measure method：

using Short form of the World Health Organization Quality of Life Measurement Scale

Outcome：

Short form of the World Health Organization Quality of Life Measurement Scale

Type：

Secondary indicator

Measure time point of outcome：

baseline, the 3rd month, the 6th month

Measure method：

using Short form of the World Health Organization Quality of Life Measurement Scale

Outcome：

Boston Naming Test(BNT)

Type：

Secondary indicator

Measure time point of outcome：

baseline, the 3rd month, the 6th month

Measure method：

using Boston Naming Test(BNT)

Outcome：

P300 latency and amplitude

Type：

Secondary indicator

Measure time point of outcome：

baseline, the 3rd month, the 6th month

Measure method：

using a randomized stimulation sequence for data acquisition by a Dandy KEYPOINT electromyography/evoked potential instrument in Denmark.

Outcome：

Mini-mental state examination (MMSE)

Type：

Secondary indicator

Measure time point of outcome：

baseline, the 3rd month, the 6th month

Measure method：

using Mini-mental state examination (MMSE)

Collecting sample(s)
from participants：

Sample Name：

Blood

Tissue：

Fate of sample 

Destruction after use

Note：

Recruiting

55
Min age years
75
Max age years

Recruiting status：

Participant age：

Gender：

Both

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

A central stochastic scheme generated by a computer.

Blinding：

Open label with evaluators blind to the groups

IPD sharing：

Yes

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

Six months after the completion of the trial Resman

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

The data were stored in the hospital 's public platform for clinical trial data management with expert guidance on self-management including raw data case report forms and use with excel data sheets

Data Managemen Committee：

Yes

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

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