Efficacy of Acupuncture-Mesalazine Combination Therapy in Ulcerative Colitis.
Not applicable · Testing Acupuncture and Mesalazine · 1 site · Qin Yu
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Acupuncture (a device) and Mesalazine (a drug) as a possible treatment. Condition(s) listed: Ulcerative Colitis.
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is blinded: participants and the study team do not know who receives what.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 75
- Any sex
Some of the main requirements, copied from the record:
- documented diagnosis of UC;
- age 18-75 years, regardless of gender;
- mildly to moderately active UC, defined as a baseline total Mayo score between 3 and 10;
Plus 4 more requirement(s). There are also 12 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 66 participants are expected to take part.
- Start date: 2026-02-01.
- Main results expected around 2027-09-30 (estimate from the record).
- 1 study site listed (1 marked recruiting) in China.
Main thing being measured
- Clinical remission rate (Week 13-16 after randomization)
In the researchers’ words
This study aims to evaluate the efficacy and safety of acupuncture combined with mesalazine (an integrated acupuncture-medication regimen) for ulcerative colitis.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Ulcerative Colitis |
| Lead sponsor | Qin Yu |
| Enrollment | 66 (estimated) |
| Start date | 2026-02-01 |
| Primary completion (est.) | 2027-09-30 |
| First posted | 2026-02-05 |
| Last updated | 2026-08-25 |
| Official title | Efficacy of Acupuncture Combined With Mesalazine in Inducing and Maintaining Clinical Remission in Mild-to-Moderate Active Ulcerative Colitis: A Single-Center, Randomized Controlled Clinical Trial. |
| ClinicalTrials.gov ID | NCT07389824 |
Interventions
- Acupuncture (Device)
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 (Device)
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 (Drug)
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.
Full eligibility criteria (from the record)
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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan, Hubei | China | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.