Stroke Patients With ConstipationNCT07372326
A Study on the Effect of Electronic Moxibustion Based on Ziwu Liuzhu in Treating Constipation in Stroke Patients
A study testing Electronic moxibustion instrument and An electronic moxibustion device under the guidance of the Yuziuyouluo theory in people with Stroke Patients With Constipation, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Stroke Patients With Constipation
- What is being tested?
- Electronic moxibustion instrument and An electronic moxibustion device under the guidance of the Yuziuyouluo theory
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2025to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- The condition is stable, without severe clinical complications;
- Can accept moxibustion treatment, and the local skin is undamaged;
- Those who agree to participate in this study and sign the informed consent form.
Who cannot join
- 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.
- The patient had constipation before the stroke.
- The patient withdrew from the study due to other reasons during the course of the study.
- Dropout criteria and termination criteria:
- Patients who have not received the prescribed treatment and whose therapeutic effect cannot be determined;
- Patients who experience serious adverse events or complications and are not suitable to continue the treatment and thus the trial is terminated;
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
4th Affiliated Hospital, School of Medicine, Zhejiang University
Jinhua, Zhejiang, 322000
ruirui Fan, +86 13858072032, 443678514@qq.com
About this study
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.
Read the 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.
- Conditions
- Stroke Patients With Constipation
- Being tested
- Electronic moxibustion instrument, An electronic moxibustion device under the guidance of the Yuziuyouluo theory
- Keywords
- cerebral hemorrhage, constipation, midnight-midday ebb flow, electronic moxibustion
- Medical subject headings
- Cerebral Hemorrhage, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic moxibustion instrumentDevice
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.
An electronic moxibustion device under the guidance of the Yuziuyouluo theoryDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Conventional nursing methods for treating constipation after stroke | No intervention | (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. |
| Electro-acupuncture therapy under the guidance of the theory of meridian flow | Experimental | 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. Receives: Device: An electronic moxibustion device under the guidance of the Yuziuyouluo theory |
| electronic moxibustion | Experimental | 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. Receives: Device: Electronic moxibustion instrument |
What is being measured
The primary outcome is the main question the study is designed to answer.
The first time of defecation
Measured: The timing of the intervention starts from the moment it begins until the first successful defecation occurs, and is recorded in hours (h).
Secondary outcomes (1)
Clinical Symptom Score Scale (CCS)
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.
Measured: An assessment was conducted before the experimental intervention, on the 7th day of the intervention, and after the completion of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start15 May 2025
- Primary completion30 Mar 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke Patients With ConstipationStudies of the same condition, open and under way.
- More trials run by The Fourth Affiliated Hospital of Zhejiang University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07372326
- Sponsor's protocol ID
- KY-2025-055
- Status last verified
- Jan 2026
- First submitted
- 11 Dec 2025
- Last updated
- 28 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Effect of Electronic Moxibustion Based on Ziwu Liuzhu in Treating Constipation in Stroke Patients
- ClinicalTrials.gov ID
- NCT07372326
- Acronym / sponsor ID
- KY-2025-055
- Conditions
- Stroke Patients With Constipation
- Keywords
- cerebral hemorrhage, constipation, midnight-midday ebb flow, electronic moxibustion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 15 May 2025 (actual)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional nursing methods for treating constipation after stroke | No intervention | –(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. |
| Electro-acupuncture therapy under the guidance of the theory of meridian flow | Experimental | Device: An electronic moxibustion device under the guidance of the Yuziuyouluo theoryThe 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. |
| electronic moxibustion | Experimental | Device: Electronic moxibustion instrumentThe 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. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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;
- The condition is stable, without severe clinical complications;
- Can accept moxibustion treatment, and the local skin is undamaged;
- Those who agree to participate in this study and sign the informed consent form.
Key exclusion criteria (8 listed)
- 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.
- The patient had constipation before the stroke.
- The patient withdrew from the study due to other reasons during the course of the study.
- Patients who have not received the prescribed treatment and whose therapeutic effect cannot be determined;
- Patients who experience serious adverse events or complications and are not suitable to continue the treatment and thus the trial is terminated;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic moxibustion instrumentThe 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. | Device | electronic moxibustion |
| An electronic moxibustion device under the guidance of the Yuziuyouluo theoryThe 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 | Electro-acupuncture therapy under the guidance of the theory of meridian flow |
Primary outcome
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).
1 secondary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic moxibustion instrument and An electronic moxibustion device under the guidance of the Yuziuyouluo theory in people with Stroke Patients With Constipation, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ruirui Fan (+86 13858072032, 443678514@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.