Efficacy of Acupuncture-Mesalazine Combination Therapy in Ulcerative Colitis.
Recruiting · NCT07389824 · Interventional (participants receive a specific treatment) · Lead sponsor: Qin Yu
View the official record on ClinicalTrials.gov →Interventions studied
AcupunctureMesalazineSham acupuncture
What this trial is about
This study aims to evaluate the efficacy and safety of acupuncture combined with mesalazine (an integrated acupuncture-medication regimen) for ulcerative colitis.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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;
- willing to receive the complete protocol of intradermal thumbtack needle embedding therapy (12 sessions across three treatment courses);
- Willing to undergo two colonoscopies (pre-treatment and post-treatment);
- complete all baseline assessments;
- capable of understanding and voluntarily sign the informed consent form.
Exclusion criteria
- diagnosed with or suspected to have other type of inflammatory bowel disease, such as Crohn's disease;
- patients in clinical remission or with severe disease activity ( baseline total Mayo score \< 3, or \> 10 );
- 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.
- patients unwilling to undergo colonoscopy;
- significant or unstable comorbidities (e.g., cardiovascular, respiratory, hepatic, or renal diseases);
- patients with malignant tumors (including but not limited to colorectal cancer);
- patients with a history of intradermal thumbtack needle embedding;
- pregnant or lactating women;
- patients with mental illness;
- patients with either coagulation disorders or skin conditions (such as diseases, infections, ulcers, scars, or tumors at the acupuncture sites) that would preclude acupuncture;
- strong needle phobia or unwillingness to receive acupuncture treatment;
- 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 is running
1 location listed.
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology - Wuhan, Hubei, China