Acupuncture plus mesalazine for ulcerative colitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized controlled trial compares an acupuncture regimen using intradermal thumbtack needle embedding plus mesalazine against sham acupuncture and mesalazine in adults with mildly to moderately active ulcerative colitis. Participants undergo 12 acupuncture sessions over three treatment courses and will have colonoscopies before and after treatment to assess changes in disease activity. The study aims to determine the safety and potential benefits of combining acupuncture with standard therapy and to explore possible mechanisms. The investigation will focus on whether the combination improves clinical outcomes beyond mesalazine alone. Researchers will monitor adverse events and treatment tolerability throughout the study.

Why it matters

Who can join: the full rules

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.

Where it's running

• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
  Wuhan, Hubei, China Recruiting

Study contacts

• Principal investigator: Yu Qin — Tongji Hospital
• Study coordinator: Zhou Pu
• Email: tongjihlunli@163.com
• Phone: 02783663625

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.