A Study on the Effect of Electronic Moxibustion Based on Ziwu Liuzhu in Treating Constipation in Stroke Patients

January 19, 2026 updated by: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
This study aims to explore the application effect of Ziwu Liuzhu electronic moxibustion combined with auricular points on constipation in stroke patients through clinical controlled trials, as well as the advantages over using electronic moxibustion alone.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study aims to explore the application effect of Ziwu Liuzhu electronic moxibustion combined with auricular points on constipation in stroke patients through clinical controlled trials, as well as the advantages over using electronic moxibustion alone. It provides new explorations, new ideas and new methods for the effective clinical care of constipation in stroke patients, and offers theoretical and guiding basis for the application and promotion of electronic moxibustion.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
105

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Zhejiang
      • Jinhua, Zhejiang, China, 322000
        • Recruiting
        • 4th Affiliated Hospital, School of Medicine, Zhejiang University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  1. Meets the diagnostic criteria of both Western medicine and traditional Chinese medicine, and has not undergone surgery or other internal medical treatments, with the occurrence of constipation;
  2. The condition is stable, without severe clinical complications;
  3. Can accept moxibustion treatment, and the local skin is undamaged;
  4. Those who agree to participate in this study and sign the informed consent form.

Exclusion criteria:

  1. Digestive tract disorders, such as intestinal polyps, tuberculosis, and tumors. Irritable bowel syndrome or constipation secondary to organic diseases (such as endocrine, metabolic or post-operative diseases); abdominal aneurysm, hepatosplenomegaly, or severe cardiovascular, liver, kidney or mental disorders and coagulation disorders.
  2. The patient had constipation before the stroke.
  3. The patient withdrew from the study due to other reasons during the course of the study.

Dropout criteria and termination criteria:

  1. Patients who have not received the prescribed treatment and whose therapeutic effect cannot be determined;
  2. Patients who experience serious adverse events or complications and are not suitable to continue the treatment and thus the trial is terminated;
  3. Patients with poor compliance, who withdraw from the treatment during the course of the trial, or who use treatment methods prohibited by this protocol concurrently, or who change the treatment method halfway on their own.

Note: For any patient meeting any of the above criteria 1, they will be handled as a dropout case.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Conventional nursing methods for treating constipation after stroke
(1) Basic treatment includes drug therapy: oral and intravenous medications are administered based on the principles of "controlling blood pressure, blood sugar, and anti-platelet aggregation". (2) Psychological care. Provide psychological and comfort care for the patients to enable them to receive treatment in a comfortable and hospitable environment. (3) Dietary care. Adopt a light diet and increase intake of low-fat, high-fiber, high-vitamin, and high-protein foods. (4) Rehabilitation exercises: bedpan training, abdominal massage, etc.
Experimental: Electro-acupuncture therapy under the guidance of the theory of meridian flow
The intervention group C patients were given electronic moxibustion therapy based on the theory of Ziwen Liuzhun (midnight to dawn) under the premise of the control group B. According to the theory of Ziwen Liuzhun, the hour of Ba (05:00 - 07:00) is the time when the large intestine meridian is in charge, and at this time, the blood and qi of the large intestine are abundant, which is most conducive to excretion. The hour of Chen (07:00 - 09:00) is the time when the stomach meridian is in charge, and at this time, the qi of the stomach meridian is vigorous, which is most conducive to regulating the connection between the stomach and the spleen. Based on the specific conditions of each patient, moxibustion treatment was given at the corresponding hour. The specific moxibustion therapy was the same as that of the control group. The intervention lasted for 2 weeks.
Device: An electronic moxibustion device under the guidance of the Yuziuyouluo theory
The intervention group C patients were given electronic moxibustion therapy based on the theory of Ziwen Liuzhun (midnight to dawn) under the premise of the control group B. According to the theory of Ziwen Liuzhun, the hour of Ba (05:00 - 07:00) is the time when the large intestine meridian is in charge, and at this time, the blood and qi of the large intestine are abundant, which is most conducive to excretion. The hour of Chen (07:00 - 09:00) is the time when the stomach meridian is in charge, and at this time, the qi of the stomach meridian is vigorous, which is most conducive to regulating the connection between the stomach and the spleen. Based on the specific conditions of each patient, moxibustion treatment was given at the corresponding hour. The specific moxibustion therapy was the same as that of the control group. The intervention lasted for 2 weeks.
Experimental: electronic moxibustion
The intervention group B added electronic moxibustion to the treatment of group A: Assist the patient to assume the supine position, aim at the moxibustion areas around the navel (Shenque, Guanyuan, Qihai, Xiaquan, Tianqiu), and use electronic moxibustion therapy (Production License No. 20180137 of Su Food and Drug Administration). The distance from the skin was 5 to 10 cm, and each area was moxibustion for 30 minutes. During the moxibustion process, ask the patient if there is any discomfort, observe the patient's skin condition, and assist the patient to put on clothes and take a comfortable lying position after the treatment.
Device: Electronic moxibustion instrument
The intervention group B added electronic moxibustion to the treatment of group A: Assist the patient to assume the supine position, aim at the moxibustion areas around the navel (Shenque, Guanyuan, Qihai, Xiaowan, Tianqiu), and use electronic moxibustion therapy (Production License No. 20180137 of Su Food and Drug Administration). The distance from the skin is 5 to 10 cm, and each area is moxibustion for 30 minutes. During the moxibustion process, ask the patient if there is any discomfort, observe the patient's skin condition, and assist the patient to put on clothes and take a comfortable lying position after the treatment.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The first time of defecation
Time Frame: The timing of the intervention starts from the moment it begins until the first successful defecation occurs, and is recorded in hours (h).
The timing of the intervention starts from the moment it begins until the first successful defecation occurs, and is recorded in hours (h).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical Symptom Score Scale (CCS)
Time Frame: An assessment was conducted before the experimental intervention, on the 7th day of the intervention, and after the completion of the intervention.
CCSis mainly used to assess the severity of constipation and has good reliability and validity. It is widely used in clinical trial evaluations. The items involved all match the items of the Rome IV standard. Except for one item with a score range of 0-7, the score range of all other items is 0-4. The higher the total score, the more severe the constipation.
An assessment was conducted before the experimental intervention, on the 7th day of the intervention, and after the completion of the intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 15, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 11, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KY-2025-055

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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