Efficacy of Acupuncture-Mesalazine Combination Therapy in Ulcerative Colitis.

Sponsor
Qin Yu
Study ID
NCT07389824
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

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.

Study Details

This study aims to evaluate the efficacy and safety of acupuncture combined with mesalazine (an integrated acupuncture-medication regimen) for ulcerative colitis.

Key Dates

First listed
Feb 5, 2026
Start date
Feb 1, 2026
Status verified
Jan 2026
Primary completion
Sep 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Verum acupuncture
    Participants receive intradermal thumbtack needle embedding at four fixed acupoints (bilateral BL25 and ST36) and one optional pair selected from ST25 (for damp-heat), BL20 (for spleen deficiency/dampness), BL23 (for spleen-kidney yang deficiency), or SP6 (for liver depression/spleen deficiency) based on TCM pattern diagnosis. Needles are embedded for up to 72 hours; patients press them 3-5 times daily to elicit deqi sensation. Needles are replaced weekly for 12 weeks. All participants concurrently receive standard mesalazine therapy.
  • Sham Comparator: sham acupuncture
    Participants receive sham acupuncture using needle-free adhesive placebo patches (identical in appearance to verum needles) applied at two fixed pairs of non-acupoints (4 points total), away from true meridians or acupoints. Patients are instructed to apply gentle pressure to the patch sites 3-5 times daily , without eliciting deqi sensation. Patches are replaced weekly for 12 consecutive weeks. All participants concurrently receive standard mesalazine therapy.

Primary Outcome Measure

Clinical remission rate [ Time Frame: Week 13-16 after randomization ]

Central Contacts

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