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Observation of the Therapeutic Efficacy of Abdominal Massage Therapy for Generalized Anxiety Disorder and Its Effects on Intestinal Microbiota

Registration number：

ITMCTR2024000140

Date of Last Refreshed on：

2024-07-30

Date of Registration：

2024-07-30

Registration Status：

Prospective registration

Public title：

Observation of the Therapeutic Efficacy of Abdominal Massage Therapy for Generalized Anxiety Disorder and Its Effects on Intestinal Microbiota

English Acronym：

Scientific title：

Observation of the Therapeutic Efficacy of Abdominal Massage Therapy for Generalized Anxiety Disorder and Its Effects on Intestinal Microbiota

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Zhang Haining

Study leader：

Wang Jingui

Applicant telephone：

+86 18822588505

Study leader's telephone：

+86 13602179966

Applicant Fax：

Study leader's fax：

Applicant E-mail：

zhn7130808@163.com

Study leader's E-mail：

wjg65tj@163.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

NO.88 Changling Road, Xiqing District, Tianjin, China

Study leader's address：

NO.88 Changling Road, Xiqing District, Tianjin, China

Applicant postcode：

300381

Study leader's postcode：

300381

Applicant's institution：

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

TYLL2024[Z]字 041

Approved file of Ethical Committee：

View

Name of the ethic committee：

IRB of The First Teaching Hospital of Tianjin University of TCM

Date of approved by ethic committee：

2024/6/19 0:00:00

Contact Name of the ethic committee：

Zheng Ziqi

Contact Address of the ethic committee：

NO.88 Changling Road, Xiqing District, Tianjin, China

Contact phone of the ethic committee：

022-27986258

Contact email of the ethic committee：

b1s1z1@sina.com

Primary sponsor：

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Primary sponsor's address：

NO.88 Changling Road, Xiqing District, Tianjin, China

Secondary sponsor：

Country：

China

Province：

Tianjin

City：

Xiqing District

Institution
hospital：

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Address：

NO.88 Changling Road, Xiqing District, Tianjin, China

Source(s) of funding：

Tianjin Nankai District Traditional Chinese Medicine Inheritance and Innovation Development Demonstration Pilot Project - High level Key Discipline - Tuina (2024)

Target disease：

Generalized Anxiety Disorder

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Pilot clinical trial

Objectives of Study：

The aim of this study is to observe the efficacy of the combination of abdominal massage therapy and escitalopram in the treatment of GAD. By combining EEG examination indicators with anxiety assessment scales, we aim to establish a quantitative correlation between GAD patient symptom scores and objective examination indicators based on previous qualitative studies on the correlation between physical and chemical indicators and GAD. This will provide auxiliary diagnostic indicators and objective visual clinical efficacy evaluation indicators for GAD. Using fecal 16S rDNA gene sequencing technology to observe the diversity, richness, and population structure of the gut microbiota in GAD patients at the microscale, as well as the regulatory effect of the abdominal massage method on the gut microbiota of patients, in order to further explore the brain gut interaction mechanism of the abdominal massage method in improving GAD based on MGBA theory. This study is based on the combination of traditional Chinese medicine theory and modern research technology, relying on clinical efficacy and enriching scientific basis, in order to provide a better clinical plan for the treatment of emotional diseases with tuina.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

① Meets the diagnostic criteria for generalized anxiety disorder in both traditional Chinese and Western medicine; ② Gender not limited, age between 18-70 years old; ③ Before the experiment, the HAMA score was between 14-29 points, indicating that the patient had mild to moderate generalized anxiety disorder; ④ Individuals who have not taken any other anti anxiety or psychiatric medications within the past month; ⑤ I voluntarily and sign the relevant informed consent form.

Exclusion criteria：

① Exclude anxiety states induced by physical illnesses such as hypertension, Sjogren's syndrome, hyperthyroidism, coronary heart disease, etc; ② Exclude anxiety caused by taking medications that can easily cause anxiety disorders, or by withdrawal reactions from long-term use of anti anxiety drugs; ③ Exclude anxiety states associated with other mental illnesses; ④ Individuals with severe liver and kidney function damage who cannot cooperate with medication; ⑤ Individuals who are allergic to known components of the drugs used in this study; ⑥ Pregnant or lactating women.

Study execute time：

From 2024-08-01

To      2026-05-31

Recruiting time：

From 2024-08-01

To      2025-05-31

Interventions：

35

Group：

Experimental group

Sample size：

Intervention：

Abdominal massage technique + Escitalopram

Intervention code：

35

Group：

Control group

Sample size：

Intervention：

Escitalopram

Intervention code：

Total sample size ： 70

Countries of recruitment
and research settings：

Country：

China

Province：

Tianjin

City：

Xiqing District

Institution/hospital：

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Level of the institution：

Public tertiary hospital

Outcomes：

Outcome：

SCL-90

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Electroencephalogram examination

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Hamilton Anxiety Scale

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Hamilton Depression Scale

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Intestinal microbiota testing

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

faeces

Tissue：

Fate of sample 

Destruction after use

Note：

Not yet recruiting

18
Min age years
70
Max age years

Recruiting status：

Participant age：

Gender：

Both

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

After recruitment and baseline measurement, independent office personnel generated a randomized number table using a random number generator (Strategic Applications Software, version 9.1.3; SAS Institute Inc). Simultaneously prepare a randomized database. Random numbers are placed in sealed envelopes, which are numbered in sequence. The therapist opens the envelopes in front of the patients one by one and randomly assigns them to two groups in a 1:1 ratio. Except for massage therapists, other researchers, including statisticians, outcome assessors, and data analysts, are unaware of group assignments, and massage therapists do not participate in outcome assessments or data analysis. Finally, GAD patients were randomly divided into an experimental group and a control group, with 35 cases in each group, using the computer random number method.

Blinding：

IPD sharing：

Yes

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

ResMan (www.medresman.org.cn)

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

Case Record Form

Data Managemen Committee：

Not yet

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

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