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The Efficacy and Mechanisms of the "Jin's Three-Needle" Therapy for Severe Stroke Patients with Paralytic Ileus

Registration number：

ITMCTR2025000003

Date of Last Refreshed on：

2025-01-01

Date of Registration：

2025-01-01

Registration Status：

Prospective registration

Public title：

The Efficacy and Mechanisms of the "Jin's Three-Needle" Therapy for Severe Stroke Patients with Paralytic Ileus

English Acronym：

Scientific title：

The Efficacy and Mechanisms of the "Jin's Three-Needle" Therapy for Severe Stroke Patients with Gastrointestinal Paralysis

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Nie Dehui

Study leader：

Lu Liming

Applicant telephone：

13539938626

Study leader's telephone：

13751779800

Applicant Fax：

Study leader's fax：

Applicant E-mail：

niedehui7@163.com

Study leader's E-mail：

lulimingleon@gzucm.edu.cn

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

uangzhou University of Chinese Medicine No. 232 Waihuan East Road University Town Panyu District Guangzhou City Guangdong Province

Study leader's address：

uangzhou University of Chinese Medicine No. 232 Waihuan East Road University Town Panyu District Guangzhou City Guangdong Province

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Guangzhou University of Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

2024ZSZY-LL-KY-230（01）

Approved file of Ethical Committee：

View

Name of the ethic committee：

Zhongshan Traditional Chinese Medicine Hospital Ethics Committee

Date of approved by ethic committee：

2024/11/8 0:00:00

Contact Name of the ethic committee：

Zhang Liyu

Contact Address of the ethic committee：

No. 3 Kangxin Road West District Zhongshan City Guangdong Province China

Contact phone of the ethic committee：

0760-89980301

Contact email of the ethic committee：

zsszyyllwyh@163.com

Primary sponsor：

Zhongshan Traditional Chinese Medicine Hospital

Primary sponsor's address：

No. 3 Kangxin Road West District Zhongshan City Guangdong Province China

Secondary sponsor：

Country：

China

Province：

Guangdong

City：

Zhongshan

Institution
hospital：

Zhongshan Traditional Chinese Medicine Hospital

Address：

No. 3 Kangxin Road West District Zhongshan City Guangdong Province China

Country：

China

Province：

Guangdong

City：

Zhongshan

Institution
hospital：

Sun Yat-sen Memorial Hospital Sun Yat-sen University

Address：

No. 33 Yingfeng Road Haizhu District Guangzhou Guangdong Province China

Source(s) of funding：

High-Level Team Recruitment Grant

Target disease：

Severe Stroke with Paralytic Ileus

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Others

Objectives of Study：

This study aims to evaluate the clinical efficacy of the "Jin's Three-Needle" therapy for severe stroke with paralytic ileus and explore its potential mechanisms. The primary outcome is weekly spontaneous bowel movements (WSBM) which directly reflects the recovery of gastrointestinal motility. The key secondary outcome is the Glasgow Coma Scale (GCS) score which measures improvements in neurological function. Additional secondary outcomes include bowel movement regularity use of rescue medications abdominal circumference bowel sounds the National Institutes of Health Stroke Scale (NIHSS) score the modified Rankin Scale (mRS) score and hospital length of stay. Together these metrics comprehensively assess the overall effects of acupuncture therapy on gastrointestinal and neurological functions.To further investigate the role of acupuncture in regulating the gut-brain axis this study will collect fecal samples for gut microbiome metagenomic and metabolomic analyses as well as blood samples for metabolomic analy

Description for medicine or protocol of treatment in detail：

This study will randomly assign participants into two groups: the acupuncture group and the sham acupuncture group. The acupuncture group will receive true acupuncture treatment while the sham acupuncture group will receive placebo acupuncture. Both groups will use the same set of acupoints including the "Gastric Three Needles" "Intestinal Three Needles" and "Calm the Mind Needles." All patients will receive the same standard basic treatment. The treatment protocol involves one session of acupuncture per day for two consecutive weeks totaling 14 sessions. Follow-up assessments will be conducted at week 4 and week 6 to evaluate the sustained effects of the treatment.

Inclusion criteria

①Meeting the diagnostic criteria for severe stroke with a Glasgow Coma Scale (GCS) score ≤12. ②Clinically confirmed diagnosis of gastrointestinal paralysis with enteral nutrition provided for more than 48 hours. ③Age between 18 and 65 years inclusive with no gender restriction. ④Relatively stable vital signs for at least 24 hours with an APACHE II score <31. ⑤The patient or their legal representative has been informed about the study and has signed the informed consent for

Exclusion criteria：

①Patients with contraindications to acupuncture (e.g. severe skin diseases bleeding disorders etc.). ②Patients with severe cardiac hepatic or renal dysfunction severe electrolyte imbalance (e.g. hypokalemia) or other serious systemic diseases. ③Pregnant or breastfeeding women. ④Patients with a history of severe primary gastrointestinal diseases (e.g. inflammatory bowel disease irritable bowel syndrome gastrointestinal bleeding gastrointestinal perforation functional constipation) or a history of gastrointestinal surgery (e.g. gastrointestinal stoma extensive gastrointestinal resection). ⑤Patients in a state of persistent agitation or status epilepticus unable to cooperate with the study or potentially affecting study outcomes. ⑥Patients who have received laxatives (e.g. lactulose) or prokinetic agents (e.g. neostigmine) prior to the trial. ⑦Patients with a history of probiotic use within the past two weeks.

Study execute time：

From 2025-01-01

To      2026-06-10

Recruiting time：

From 2025-01-06

To      2026-06-10

Interventions：

50

Group：

Sham acupuncture group

Sample size：

Intervention：

placebo acupuncture plus standard care

Intervention code：

50

Group：

Acupuncture group

Sample size：

Intervention：

True acupuncture plus standard care

Intervention code：

Total sample size ： 100

Countries of recruitment
and research settings：

Country：

China

Province：

Guangdong Province

City：

Zhongshan City

Institution/hospital：

Zhongshan Traditional Chinese Medicine Hospital

Level of the institution：

Tertiary Grade-A Hospital

Outcomes：

Outcome：

Incidence of Adverse Events and Serious Adverse Events

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

Glasgow Coma Scale (GCS)

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

National Institutes of Health Stroke Scale (NIHSS)

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Abdominal Circumference

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Modified Rankin Scale (mRS)

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Use of Rescue Medications

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Assessment of Bowel Movement Regularity

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Weekly Spontaneous Bowel Movements (WSBM)

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

omics biomarkers

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Length of Hospitalization

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Bowel Sounds

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

Blood

Tissue：

Body Fluid

Fate of sample 

Destruction after use

Note：

Sample Name：

Fecal

Tissue：

intestinal

Fate of sample 

Destruction after use

Note：

Not yet recruiting

18
Min age years
64
Max age years

Recruiting status：

Participant age：

Gender：

Both

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

This study employs a central randomization system with stratified block randomization to ensure balanced allocation of patients with different disease types (ischemic stroke intracerebral hemorrhage and aneurysmal subarachnoid hemorrhage) between the acupuncture and control groups. Initially all eligible patients are stratified by disease type forming three independent strata. Within each stratum block randomization is performed using block sizes of 4 or 6 with a 1:1 allocation ratio between the acupuncture and control groups. The random assignment within each stratum is automatically executed by the central randomization system ensuring both randomness and allocation concealment. Once the investigator confirms an eligible case a request is submitted to the central randomization system. The system then automatically assigns the group information and sends it to the investigator. Based on the assigned group the investigator provides the corresponding intervention to the participant.

Blinding：

IPD sharing：

No

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

Contact the project leader for raw data

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

CRF is used for data acquisition and management

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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