Health Trials

Efficacy of Acupuncture-Mesalazine Combination Therapy in Ulcerative Colitis.

ConditionUlcerative Colitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorQin Yu

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)；

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

66 Participants
are divided into 2 treatment groups
Group A: Verum acupunctureExperimental treatment 2 interventions
Group B: sham acupunctureSham comparator 2 interventions

Trial outcomes

Primary outcomes

1

Clinical remission rate

Proportion of patients who achieve a Mayo Stool Frequency Subscore (SFS) of 0 or 1 and not increased from induction baseline, a Mayo Rectal Bleeding Subscore (RBS) of 0, and a Mayo Endoscopic Score(MES) of 0 or 1 with no friability present on endoscopy.

Time frame
Week 13-16 after randomization

Secondary outcomes

1

Clinical response rate

Proportion of patients with a decrease from induction baseline in the mMayo score by at least 30% and at least 2 points, with either a 1-point or more decrease from induction baseline in the Mayo Rectal Bleeding Subscore (RBS) or a Mayo RBS of 0 or 1

Time frame
Week 13-16 after randomization
2

Endoscopic improvement rate

Proportion of patients with a Mayo Endoscopic Subscore (MES) of 0 or 1 (no friability) or an Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score of 0 or 1.

Time frame
Week 13-16 after randomization
3

Endoscopic remission (normalization) rate

Proportion of patients with a Mayo Endoscopic Subscore (MES) of 0.

Time frame
Week 13-16 after randomization
4

Symptomatic remission rate

Proportion of patients with a Mayo Stool Frequency Subscore (SFS) of 0 or 1 and not increased from induction baseline, and a Mayo Rectal Bleeding Subscore (RBS) of 0

Time frame
Week 12 and 24 after randomization

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Qin Yu

Lead sponsor

Tongji Hospital

Sponsor institution

Source ClinicalTrials.gov
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