NCT07372326

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started May 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress74%
May 2025Oct 2026

Study Start

First participant enrolled

May 15, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 28, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2026

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2026

Expected
Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

11 months

First QC Date

December 11, 2025

Last Update Submit

January 19, 2026

Conditions

Keywords

cerebral hemorrhageconstipationmidnight-midday ebb flowelectronic moxibustion

Outcome Measures

Primary Outcomes (1)

  • The first time of defecation

    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)

    An assessment was conducted before the experimental intervention, on the 7th day of the intervention, and after the completion of the intervention.

Study Arms (3)

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.

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.

Device: Electronic moxibustion instrument

Interventions

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.

Electro-acupuncture therapy under the guidance of the theory of meridian flow

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.

electronic moxibustion

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

4th Affiliated Hospital, School of Medicine, Zhejiang University

Jinhua, Zhejiang, 322000, China

RECRUITING

MeSH Terms

Conditions

Cerebral HemorrhageConstipation

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveSigns and Symptoms

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2025

First Posted

January 28, 2026

Study Start

May 15, 2025

Primary Completion

March 30, 2026

Study Completion (Estimated)

October 30, 2026

Last Updated

January 28, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations