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Clinical study on acupuncture treatment of spleen stomach weakness type tinnitus guided by the theory of brain gut axis

Registration number：

ITMCTR2024000643

Date of Last Refreshed on：

2024-11-03

Date of Registration：

2024-11-03

Registration Status：

Retrospective registration

Public title：

Clinical study on acupuncture treatment of spleen stomach weakness type tinnitus guided by the theory of brain gut axis

English Acronym：

Scientific title：

Clinical study on acupuncture treatment of spleen stomach weakness type tinnitus guided by the theory of brain gut axis

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Jiao Liang

Study leader：

Jiao Liang

Applicant telephone：

15171917880

Study leader's telephone：

15171917880

Applicant Fax：

Study leader's fax：

Applicant E-mail：

20230028@cqtgmc.edu.cn

Study leader's E-mail：

20230028@cqtgmc.edu.cn

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

No. 366 Tianxing Road Bai'anba Wanzhou District Chongqing

Study leader's address：

No. 366 Tianxing Road Bai'anba Wanzhou District Chongqing

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Chongqing Three Gorges Medical College

Approved by ethic committee：

Approved No. of ethic committee：

SXYZ-H-2309-0001

Approved file of Ethical Committee：

View

Name of the ethic committee：

Biomedical Ethics Committee of Chongqing Three Gorges Medical College

Date of approved by ethic committee：

2023/9/26 0:00:00

Contact Name of the ethic committee：

Li Qingyun

Contact Address of the ethic committee：

No. 366 Tianxing Road Bai'anba Wanzhou District Chongqing

Contact phone of the ethic committee：

023-58556521

Contact email of the ethic committee：

20220443@cqtgmc.edu.cn

Primary sponsor：

Chongqing Three Gorges Medical College

Primary sponsor's address：

No. 366 Tianxing Road Bai'anba Wanzhou District Chongqing

Secondary sponsor：

Country：

China

Province：

Chongqing

City：

Wanzhou

Institution
hospital：

Chongqing Three Gorges Medical College

Address：

No. 366 Tianxing Road Bai'anba Wanzhou District Chongqing

Source(s) of funding：

Unit self raised

Target disease：

tinnitus

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Pilot clinical trial

Objectives of Study：

1: Exploring the clinical efficacy of acupuncture treatment for tinnitus guided by the theory of brain gut axis; 2: Detecting the levels of GABA and 5-HT in the peripheral blood of patients to explore the mechanism of acupuncture treatment for tinnitus guided by the theory of brain gut axis.

Description for medicine or protocol of treatment in detail：

Divided into two parts Experiment 1: Adopting a prospective randomized controlled principle a total of 66 patients with neurogenic tinnitus will be included. Both groups of patients receive ICBT intervention. The experimental group receive acupuncture treatment while the control group is a sham acupuncture group. The intervention time are 4 weeks 5 times a week 30 minutes each time for a total of 20 times; Hearing tests (pure tone threshold measurement PTA tinnitus matching tinnitus disability scale THI) and psychological tests (Pittsburgh Sleep Disorders Scale PSQI Life Therapy Scale SF-36 Self Rating Anxiety Scale SAS and Self Rating Depression Scale SDS) will be conducted before enrollment and after treatment. Experiment 2: Serum neurotransmitters (GABA 5-HT) will be collected from two groups of patients before enrollment and after treatment. Combining the two parts to observe the clinical efficacy of acupuncture treatment for tinnitus and explore possible mechanisms.

Inclusion criteria

1. Meet the diagnostic criteria of traditional Chinese and Western medicine for primary tinnitus and the syndrome type is spleen and stomach weakness type; 2. Age range between 18 and 80 years old (including 18 and 80 years old); 3 pairs of tolerants in this experiment; 4. Those who have not received other treatments at the same time; 5.Voluntary signatories of informed consent form; 6.People is within the scope of applicability of the technology used in this study. Anyone who meets the above six conditions is eligible to participate in this study.

Exclusion criteria：

1. Patients who have experienced new cardiovascular and cerebrovascular diseases or sudden hearing loss in the past three months; 2 Patients with a history of massive cerebral infarction severe endocrine system disease severe infectious diseases and toxic encephalopathy; 3. There is a history of dizziness with acupuncture and contraindications for acupuncture treatment include skin damage infection and other conditions that are not suitable for acupuncture treatment; 4. Consciously or mentally impaired unable to cooperate with the researcher to complete the study; 5. Women with acute abdomen pregnancy and lactation; 6. History of head and neck injuries and history of taking special medications; 7. Within the past three months the patient has undergone or is currently participating in other clinical trials;

Study execute time：

From 2024-04-01

To      2026-03-31

Recruiting time：

From 2024-10-08

To      2026-01-31

Interventions：

33

Group：

Experimental group

Sample size：

Intervention：

Acupuncture+ICBT

Intervention code：

33

Group：

Control group

Sample size：

Intervention：

Fake acupuncture +ICBT

Intervention code：

Total sample size ： 66

Countries of recruitment
and research settings：

Country：

China

Province：

Sichuan

City：

Institution/hospital：

Emeishan Traditional Chinese Medicine Hospital

Level of the institution：

Grade III Grade A Traditional Chinese Medicine Hospital

Country：

China

Province：

Chongqing

City：

Wanzhou

Institution/hospital：

Chongqing Three Gorges Medical College Affiliated People's Hospital

Level of the institution：

tertiary general hospita

Outcomes：

Outcome：

THI

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

5-HT

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

PSQI

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

SF-36

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

5-HT

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

GABA

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

PTA

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

SDS

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

SAS

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Tinnitus matching

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：

Recruiting

18
Min age years
80
Max age years

Recruiting status：

Participant age：

Gender：

Both

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

Arrange the random number table in advance and place it in an envelope. A dedicated person will be responsible for it. The random letters will be opened and registered in the order of inclusion in the study.

Blinding：

IPD sharing：

No

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

Share after the experiment is completed

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

CRF

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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