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临床试验/ACTRN12622000073707
ACTRN12622000073707尚未招募未知

A pilot study to explore the effect of traditional Chinese acupuncture as an addition to the standard care in patients with diarrhoea predominant irritable bowel syndrome

ew Zealand College of Chinese Medicine0 个研究点目标入组 40 人开始时间: 2022年1月21日最近更新:
适应症

试验速览

阶段
未知
状态
尚未招募
发起方
入组人数
40

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 50 Years(—)
性别
All

入选标准

  • Patients who are newly diagnosed with IBS-D by New Zealand registered western medical professionals, according to ROME IV criteria will be potentially eligible to participate in the study.
  • ROME IV criteria: Patients with recurrent abdominal pain at least one day per week in the last three months on average, associated with at least 2 of the criteria below. The criteria are fulfilled with symptoms onset six months before diagnosis:
  • 1 Related to defecation, either increasing or improving pain
  • 2 Associated with a change in stool frequency
  • 3 Associated with a change in stool form (appearance)
  • The Bristol Stool Form Scale (BSFS) is used to record stool consistency. The IBS-D subtype is defined as follows: more than 25% of bowel movements using the BSFS are type 6 or 7, and less than 25% of bowel movements are type 1 or 2 (European Medicines Agency, 2015; FDA, 2012). IBS-D patients can be diagnosed in a clinical situation when a patient reports that abnormal bowel movements are usually diarrhoea (BSFS type 6 or 7) (Moayyedi et al., 2017).

排除标准

  • Patients who meet the criteria below will be excluded from the study:
  • 1 Age younger than 18 or older than 50
  • 2 Individuals who cannot make independent decisions and consent
  • 3 Previously diagnosed with IBS and having received standard care
  • 4 Currently taking the following medications more than three days a week: antibiotics, narcotics, cholestyramine, colchicine, iron supplements, antispasmodics, benzodiazepines, antidepressants
  • 5 Current diagnosis of haemophilia, hepatitis, HIV or cancer
  • 6 Having had major gastrointestinal, and/or gynaecological, and/or urological surgery within the past six months
  • 7 Currently receiving complementary therapies such as acupuncture, herbs, massage and behavioural therapies
  • 8 Having bleeding disorders
  • 9 Regularly taking anticoagulants
  • 10 Having skin conditions
  • 11 Having an immunocompromised disease or taking immunosuppressant
  • 12 Having a history of convulsions
  • 13 Pregnancy
  • 14 A history of psychosis or substance abuse
  • 15 Individuals with plans for travel, lifestyle change, or other activity that would preclude attending the planned study sessions

研究者

发起方
ew Zealand College of Chinese Medicine

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