Efficacy of Acupuncture-Mesalazine Combination Therapy in Ulcerative Colitis.

NCT07389824 | Not Yet Recruiting

• 1 other identifier: UC-ACU(2025TJ01)
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ulcerative Colitis

Keywords

Acupuncture; Mesalazine; Ulcerative Colitis

Outcome Measures

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.

  Week 13-16 after randomization

Secondary Outcomes (23)

• Clinical response rate

  Week 13-16 after randomization

• Endoscopic improvement rate

  Week 13-16 after randomization

• Endoscopic remission (normalization) rate

  Week 13-16 after randomization

• Symptomatic remission rate

  Week 12 and 24 after randomization

• Symptomatic response rate

  Week 12 and 24 after randomization

Study Arms (2)

Verum acupuncture

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.

Device: Acupuncture; Drug: Mesalazine

sham acupuncture

SHAM COMPARATOR

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.

Device: Sham acupuncture; Drug: Mesalazine

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.

Also known as: Acupuncture with intradermal thumbtack needle

Verum acupuncture

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.

Also known as: Sham acupuncture with sham intradermal thumbtack needle

sham acupuncture

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.

Also known as: 5-ASA, 5-aminosalicylic acid

Verum acupuncture; sham acupuncture

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qin Yu: lead

Study Sites (1)

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

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Acupuncture Therapy; Mesalamine

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Aminosalicylic Acids; Salicylates; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols

Study Officials

• Yu Qin

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhou Pu

CONTACT

02783663625; tongjihlunli@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Chief Physician

Model Details: Participants are randomly assigned to one of two parallel groups in a 1:1 ratio.

Study Record Dates

• First Submitted: January 2, 2026
• First Posted: February 5, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD and supporting information will be available after the publication of the primary outcomes
• Access Criteria: Data requests from qualified researchers for the purpose of replicating analyses or conducting secondary analyses will be considered. Requestors must submit a research proposal outlining the scientific purpose and analysis plan to the principal investigator via the contact email. Approval will be granted based on scientific merit, feasibility, and adherence to data use agreements.

Locations

CN (1)