Status:
UNKNOWN
Efficacy of Acupuncture in Refractory Irritable Bowel Syndrome
Lead Sponsor:
Chengdu University of Traditional Chinese Medicine
Collaborating Sponsors:
Beijing University of Chinese Medicine
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The trial aims to examine the efficacy and safety of acupuncture in the treatment of refractory irritable bowel syndrome (IBS). The investigators will include 170 participants to receive acupuncture p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2022
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT04276961
Start Date
October 15 2020
End Date
June 1 2022
Last Update
May 10 2021
Active Locations (1)
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1
Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan, China, 610075