跳至主要内容
临床试验/NCT03041675
NCT03041675Unknown不适用

Effects of Laser Acupuncture Therapy on Paralytic Ileus

China Medical University Hospital2 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2017年2月13日最近更新:
适应症

试验速览

阶段
不适用
入组人数
94
试验地点
2
主要终点
the changing of diameter of colon (KUB)

研究概览

简要总结

Ileus occurs from hypomotility of the gastrointestinal tract. Causes of Paralytic ileus include post-operation, stroke, and bed-ridden for a long time. Medicine treatment is less and less effective over time. Some study revealed that Moxibustion and Acupuncture are effective in Paralytic ileus. Investigators try to find other treatment except of medicine. Laser Acupuncture is a safe and non-invasive choice. This study is to evaluate effect of Laser Acupuncture on Paralytic ileus.

详细描述

This study's sample consisted of 94 adult participants who had Paralytic ileus. Patients experiencing skin disease or wounds, pregnancy, less than 20 years old, and who take Immunosuppressants drugs or Morphine, Mechanical obstruction were excluded. These 94 patients were randomly divided into two groups: a Laser Acupuncture group and a control group. At the beginning of study, check X-ray(KUB), collect serum Gastrin, Motilin, and Pancreatic polypeptide, and record bowel sound per minute, frequent of enema, average amount of stool per day. 47 patients received Laser Acupuncture therapy three times a week in acupoints RN6, RN4, and RN12. The whole duration of treatment is 8 weeks. The control group patients receive pseudo laser acupuncture. In the end of 4th and 8th week, check X-ray(KUB), collect serum Gastrin, Motilin, and Pancreatic polypeptide, and record bowel sound per minute, observe the daily record and then calculate frequent of enema and average amount of stool per day. After the end of treatment, the investigators keep follow up for 4 weeks. The outcome parameters include:

  1. KUB,
  2. the average amount of stool every day,
  3. frequency of bowel sound,
  4. frequency of enema, (Indication of enema: the amount of stool less than 200g within 3 days),
  5. the change of serum Gastrin, Motilin, and Pancreatic polypeptide.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Already sign test consent permit.
  • More than 20-year-old.
  • Doctors diagnosis as Paralysis ileus, and KUB report was improved as Paralysis ileus by Radiologists.

排除标准

  • Pregnant.
  • Patients taking immunosuppressive or morphine analgesics.
  • Skin infections.
  • Without test consent permit.
  • mechanical ileus, mechanical obstruction.

结局指标

主要结局

the changing of diameter of colon (KUB)

时间窗: the 4th, 8th, 12th week

Definition of Ileus: Diameter of colon: \>6cm. Check KUB on the 4th, 8th, 12th week. Calculate the biggest diameter of colon. Is diameter of colon decreasing in Laser Acupuncture group?

次要结局

  • the average amount of stool per day(g/Day)(the 4th, 8th, 12th week)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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