Acupuncture: Intradermal thumbtack needle embedding at specified acupoints. Needles are embedded for up to 72 hours, replaced weekly for 12 weeks. Patients press needles 3-5 times daily to elicit deqi sensation.
Sham acupuncture: Application of needle-free adhesive placebo patches at non-acupoint sites. Patches are replaced weekly for 12 weeks. Patients apply gentle pressure 3-5 times daily without deqi sensation.
Mesalazine: Standard background therapy: Mesalazine at a stable dose (e.g., 2-4g/day) maintained throughout the 12-week study period. This provides the background treatment for both groups, allowing evaluation of the additive effect of acupuncture.
Study summary
This study aims to evaluate the efficacy and safety of acupuncture combined with mesalazine (an integrated acupuncture-medication regimen) for ulcerative colitis.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. documented diagnosis of UC;
2. age 18-75 years, regardless of gender;
3. mildly to moderately active UC, defined as a baseline total Mayo score between 3 and 10;
4. willing to receive the complete protocol of intradermal thumbtack needle embedding therapy (12 sessions across three treatment courses);
5. Willing to undergo two colonoscopies (pre-treatment and post-treatment);
6. complete all baseline assessments;
7. capable of understanding and voluntarily sign the informed consent form.
Exclusion Criteria:
1. diagnosed with or suspected to have other type of inflammatory bowel disease, such as Crohn's disease;
2. patients in clinical remission or with severe disease activity ( baseline total Mayo score \< 3, or \> 10 );
3. having severe gastrointestinal complications or a recent surgical history, including but not limited to: short bowel syndrome, toxic megacolon, intestinal perforation, complete intestinal obstruction, active massive gastrointestinal hemorrhage, or having undergone major abdominal or intestinal surgery within the past 6 months.
4. patients unwilling to undergo colonoscopy;
5. significant or unstable comorbidities (e.g., cardiovascular, respiratory, hepatic, or renal diseases);
6. patients with malignant tumors (including but not limited to colorectal cancer);
7. patients with a history of intradermal thumbtack needle embedding;
8. pregnant or lactating women;
9. patients with mental illness;
10. patients with either coagulation disorders or skin conditions (such as diseases, infections, ulcers, scars, or tumors at the acupuncture sites) that would preclude acupuncture;
11. strong needle phobia or unwillingness to receive acupuncture treatment;
12. any other condition (e.g., geographical remoteness, history of poor adherence) that, in the opinion of the investigator, would make the patient unsuitable for the study or likely to be non-compliant with the protocol.
Primary outcome measure(s)
Clinical remission rate — Week 13-16 after randomization Proportion of patients who achieve a Mayo Stool Frequency Subscore (SFS) of 0 or 1 and not increased from induction baseline, a Mayo Rectal Bleeding Subscore (RBS) of 0, and a Mayo Endoscopic Score(MES) of 0 or 1 with no friability present on endoscopy.
Trial sites (1)
Facility
City
Region
Status
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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