ACTRN12622000073707
Not yet recruiting
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 sites40 target enrollmentJanuary 21, 2022
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- irritable bowel syndrome
- Sponsor
- ew Zealand College of Chinese Medicine
- Enrollment
- 40
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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\).
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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