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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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, obs
• Устройство 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

Первичные конечные точки

• The first time of defecation [Срок оценки: The timing of the intervention starts from the moment it begins until the first successful defecation occurs, and is recorded in hours (h).]

Вторичные конечные точки (1)

• Clinical Symptom Score Scale (CCS) [Срок оценки: An assessment was conducted before the experimental intervention, on the 7th day of the intervention, and after the completion of the intervention.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• 4th Affiliated Hospital, School of Medicine, Zhejiang University — Jinhua

Идентификаторы

NCT: NCT07372326 · KY-2025-055

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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