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Acupuncture and Mesalazine for Mild-to-Moderate Active Ulcerative Colitis Remission

Study Aim

This study aims to evaluate the effectiveness of Acupuncture and Mesalazine in achieving clinical remission for individuals with mild-to-moderate active Ulcerative Colitis, as measured by improvements in stool frequency, rectal bleeding, and endoscopic scores.

What is being tested

Acupuncture

+ Mesalazine

+ Sham acupuncture

DeviceDrug

Who is being recruted

Colitis+5

+ Colitis, Ulcerative

+ Colonic Diseases

From 18 to 65 Years

+19 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-Controlled

Interventional

Study Start: February 2026

See protocol details

Summary

Principal SponsorQin Yu

Study ContactZhou Pu

Last updated: February 6, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2026

Actual date on which the first participant was enrolled.

This study focuses on individuals with mild to moderate active ulcerative colitis, a condition that causes inflammation and sores in the colon. The main goal is to explore the effectiveness and safety of acupuncture, specifically intradermal thumbtack needle embedding, when used alongside a common medication for ulcerative colitis, mesalazine. The hope is that this combination could help induce and maintain clinical remission, improving the quality of life for those living with this condition. By understanding the potential benefits of this treatment approach, researchers aim to provide new options for managing ulcerative colitis. During the study, participants receive either the real acupuncture treatment or a placebo version, alongside their usual mesalazine treatment. The acupuncture involves the use of intradermal thumbtack needles, which are embedded into specific points on the skin. The primary outcome measured is the clinical remission rate, which is determined by improvements in stool frequency, rectal bleeding, and endoscopic scores. These scores help doctors evaluate the severity of the condition. The study also looks into the potential mechanisms behind the effects of acupuncture on ulcerative colitis.

Official TitleEfficacy 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.

NCT07389824

Principal SponsorQin Yu

Study ContactZhou Pu

Last updated: February 6, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

80 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ColitisColitis, UlcerativeColonic DiseasesDigestive System DiseasesGastroenteritisGastrointestinal DiseasesIntestinal DiseasesInflammatory Bowel Diseases

Criteria

7 inclusion criteria required to participate

documented diagnosis of UC；

complete all baseline assessments;

age 18-65 years, regardless of gender;

willing to receive the complete protocol of intradermal thumbtack needle embedding therapy (12 sessions across three treatment courses)；

Show More Criteria

12 exclusion criteria prevent from participating

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.

significant or unstable comorbidities (e.g., cardiovascular, respiratory, hepatic, or renal diseases);

patients with a history of intradermal thumbtack needle embedding;

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.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

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.

Group II

Sham

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, ChinaOpen Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology in Google Maps

Recruiting soonOne Study Center