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Clinical study on the napex acupoint catgut embedding therapy combined with metoprolol tartrate tablet for prophylactic treatment of migraine without aura and brain fMRI mechanism

Registration number：

ITMCTR2024000185

Date of Last Refreshed on：

2024-08-07

Date of Registration：

2024-08-07

Registration Status：

Prospective registration

Public title：

Clinical study on the napex acupoint catgut embedding therapy combined with metoprolol tartrate tablet for prophylactic treatment of migraine without aura and brain fMRI mechanism

English Acronym：

Scientific title：

Clinical study on the napex acupoint catgut embedding therapy combined with metoprolol tartrate tablet for prophylactic treatment of migraine without aura and brain fMRI mechanism

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Lamei Tao

Study leader：

Lamei Tao

Applicant telephone：

17768101781

Study leader's telephone：

17768101781

Applicant Fax：

Study leader's fax：

Applicant E-mail：

799258654@qq.com

Study leader's E-mail：

799258654@qq.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

157 Daming Road, Nanjing, JiangsuProvince

Study leader's address：

157 Daming Road, Nanjing, Jiangsu Province

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Nanjing Hospital of Traditional Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

KY2024043

Approved file of Ethical Committee：

View

Name of the ethic committee：

EEthics Committee of Nanjing Hospital of Traditional Chinese Medicine

Date of approved by ethic committee：

2024/7/4 0:00:00

Contact Name of the ethic committee：

Desong Kong

Contact Address of the ethic committee：

157 Daming Road, Nanjing, JiangsuProvince

Contact phone of the ethic committee：

02552276505

Contact email of the ethic committee：

kongds@njucm.edu.cn

Primary sponsor：

Nanjing Hospital of Traditional Chinese Medicine

Primary sponsor's address：

157 Daming Road, Nanjing, JiangsuProvince

Secondary sponsor：

Country：

China

Province：

Jiangsu

City：

Nanjing

Institution
hospital：

Nanjing Hospital of Traditional Chinese Medicine

Address：

157 Daming Road, Nanjing, JiangsuProvince

Source(s) of funding：

2023 Annual Nanjing Hospital of Traditional Chinese Medicine Scientific Research Fund Project

Target disease：

migraine

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Others

Objectives of Study：

Preliminary clinical observation shows that the team's combination of acupuncture and medicine is effective and safe in the preventive treatment of migraine. However, it is still necessary to expand the sample size and further verify it by strictly designed randomized controlled studies, and explore the mechanism of its brain fMRI effect. To provide clinical basis for further promotion of occipito-nuchal direct acupuncture combined with metoprolol tartrate tablets in the preventive treatment of migraine without aura, and to provide evidence for explaining the mechanism of its effect.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

①Patients who met the diagnostic criteria for migraine without aura and had intermittent episodes at the time of initial treatment in this study; ②In the range of 18 to 65 years, the course of disease is more than 6 months, the average headache attack is more than 2 times per month; ③Did not receive preventive treatment of migraine including acupuncture and medicine in the past 1 month; ④The patient voluntarily received the relevant preventive treatment and signed an informed consent form.

Exclusion criteria：

①Contraindications to the use of metoprolol, including but not limited to patients with symptomatic bradycardia or hypotension, atrioventricular block, morbid sinus syndrome, heart failure, acute myocardial infarction, cardiogenic shock, severe peripheral vascular disease with gangrene, treated with β agonists, and allergic to any component or other metoprolol of β blockers; ②Organic lesions such as tumors, inflammation, and degenerative diseases; ③Combined with severe neurological, cardiovascular, digestive, urinary, blood system, endocrine system diseases unrelated to migraine; ④Pregnant and lactating women; ⑤Serious mental illness, cognitive impairment so that the normal communication and diagnosis and treatment; ⑥Have contraindications to MRI examination such as metal implants in the body and claustrophobia; ⑦Have severe asymmetric head anatomical structure or clear lesions found in MRI examination.

Study execute time：

From 2024-08-15

To      2025-12-31

Recruiting time：

From 2024-08-15

To      2025-12-31

Interventions：

10

Group：

Healthy control group

Sample size：

Intervention：

None

Intervention code：

50

Group：

Western medicine group

Sample size：

Intervention：

metoprolol tartrate tablet

Intervention code：

50

Group：

Acupuncture group

Sample size：

Intervention：

napex acupoint catgut embedding therapy

Intervention code：

50

Group：

Acupuncture and medicine group

Sample size：

Intervention：

napex acupoint catgut embedding therapy combined with metoprolol tartrate tablet

Intervention code：

Total sample size ： 160

Countries of recruitment
and research settings：

Country：

China

Province：

Jiangsu

City：

Nanjing

Institution/hospital：

Nanjing Hospital of Traditional Chinese Medicine

Level of the institution：

3

Outcomes：

Outcome：

The Migraine-specific Quality of Life Questionnaire

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

safety evaluation

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

improved response rate by 50%

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Amplitude of Low Frequency Fluctuation,ALFF

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

the number of headache attack days

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

headache severity

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

frequency of headache attacks

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Not yet recruiting

18
Min age years
65
Max age years

Recruiting status：

Participant age：

Gender：

Both

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

The SPSS 22.0 software gives the random numbers

Blinding：

IPD sharing：

No

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

/

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

CRF

Data Managemen Committee：

No

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

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