Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:47 AM
Ignite Modification Date:
2025-12-24 @ 11:47 AM
NCT ID:
NCT04276961
Eligibility Criteria:
Inclusion Criteria:
* Adults aged 18-70 years (either sex);
* Fulfilled Rome IV criteria for IBS;
* Patients with normal occult blood in stool in recent one month;
* The age is above 50, the results of colonoscopy are normal in near year;
* Symptoms are present for ≥12 months;
* There is an absence of response to a minimum of 6 weeks of dietary intervention or advice;
* There is an absence of response to an adequate dose of at least one conventional pharmacological agent tried for a minimum of 6 weeks;
* Signed the written informed consent form.
Exclusion Criteria:
* Previous colonoscopy, meal barium fluoroscopy, abdominal ultrasound and other examinations found severe intestinal organic lesions (including but not limited to ulcerative colitis, familial multiple intestinal polyps, colorectal cancer patients);
* The presence of one or more of the following warning symptoms: unexplained rectal bleeding, a positive faecal occult blood test result; anaemia, abdominal mass, ascites, fever, and emaciation;
* The presence of other severe medical conditions, such as cardiovascular disease, endocrine disorders, hepatic dysfunction, renal diseases, and cognitive disorders that can affect the outcome assessment results;
* Unconscious, unable to express subjective symptoms of discomfort and clearly diagnosed severe mental disorders;
* An unstable psychological state or accompanying psychological disorders (SDS\>56);
* With pregnancy or lactation;
* Accepting acupuncture treatment in the last 3 months;
* Difficulties in attending the trial, such as fear of acupuncture.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04276961
Study Brief:
Protocol Section:
NCT04276961