Not yet recruiting NCT07389824
Efficacy of Acupuncture-Mesalazine Combination Therapy in Ulcerative Colitis.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Acupuncture, Sham acupuncture, Mesalazine.
- Who it may be relevant to
- Registry conditions: Ulcerative Colitis. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Overview
This study aims to evaluate the efficacy and safety of acupuncture combined with mesalazine (an integrated acupuncture-medication regimen) for ulcerative colitis.
Detailed description
1. A randomized controlled trial. 2. Acupuncture treatment(intradermal thumbtack needle embedding), placebo control. 3. To explore the efficacy and safety of acupuncture(intradermal thumbtack needles embedding) as an adjuvant therapy for active ulcerative colitis. 4. To explore the potential relevant mechanisms.
Interventions
- Device 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. - Device 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. - Drug 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.
Primary outcome measures
- Clinical remission rate [Time frame: Week 13-16 after randomization]
Secondary outcome measures (12)
- Clinical response rate [Time frame: Week 13-16 after randomization]
- Endoscopic improvement rate [Time frame: Week 13-16 after randomization]
- Endoscopic remission (normalization) rate [Time frame: Week 13-16 after randomization]
- Symptomatic remission rate [Time frame: Week 12 and 24 after randomization]
- Symptomatic response rate [Time frame: Week 12 and 24 after randomization]
- Number of remission-relapse episodes [Time frame: Week 24 after randomization]
- Time to first relapse [Time frame: Week 24 after randomization]
- Use of rescue medication [Time frame: Week 24 after randomization]
- Change in Nancy Histological Index score [Time frame: Week 13-16 after randomization]
- Change in fecal calprotectin level [Time frame: Baseline, Week 12, Week 24]
- Change in C-reactive protein level [Time frame: Baseline, Week 12, Week 24]
- Change in erythrocyte sedimentation rate [Time frame: Baseline, Week 12, Week 24]
Eligibility criteria
Inclusion criteria
- documented diagnosis of UC；
- age 18-65 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan
Identifiers
NCT: NCT07389824 · UC-ACU(2025TJ01)