Efficacy of Acupuncture-Mesalazine Combination Therapy in Ulcerative Colitis.

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.

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

Study Overview

• Status: Not yet recruiting
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Device: Acupuncture; Drug: Mesalazine; Device: Sham acupuncture

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhou Pu; Phone Number: 02783663625; Email: tongjihlunli@163.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Contact: Yu Qin; Phone Number: 027-83665532; Email: yuqin@tjh.tjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. documented diagnosis of UC；
2. age 18-65 years, regardless of gender;
3. mildly to moderately active UC, defined as a baseline total Mayo score between 3 and 10；
4. willing to receive the complete protocol of intradermal thumbtack needle embedding therapy (12 sessions across three treatment courses)；
5. Willing to undergo two colonoscopies (pre-treatment and post-treatment)；
6. complete all baseline assessments;
7. capable of understanding and voluntarily sign the informed consent form.

Exclusion Criteria:

1. diagnosed with or suspected to have other type of inflammatory bowel disease, such as Crohn's disease;
2. patients in clinical remission or with severe disease activity ( baseline total Mayo score < 3, or > 10 );
3. 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.
4. patients unwilling to undergo colonoscopy;
5. significant or unstable comorbidities (e.g., cardiovascular, respiratory, hepatic, or renal diseases);
6. patients with malignant tumors (including but not limited to colorectal cancer);
7. patients with a history of intradermal thumbtack needle embedding;
8. pregnant or lactating women;
9. patients with mental illness;
10. patients with either coagulation disorders or skin conditions (such as diseases, infections, ulcers, scars, or tumors at the acupuncture sites) that would preclude acupuncture；
11. strong needle phobia or unwillingness to receive acupuncture treatment;
12. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.; Other Names: Acupuncture with intradermal thumbtack needle; 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.; Other Names: 5-ASA; 5-aminosalicylic acid
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.	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.; Other Names: 5-ASA; 5-aminosalicylic acid; 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.; Other Names: Sham acupuncture with sham intradermal thumbtack needle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Week 13-16 after randomization
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.	Week 13-16 after randomization
Endoscopic remission (normalization) rate	Proportion of patients with a Mayo Endoscopic Subscore (MES) of 0.	Week 13-16 after randomization
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	Week 12 and 24 after randomization
Symptomatic response rate	Proportion of patients with a decrease from baseline in the symptomatic Mayo score (SFS+RBS) by ≥30% and ≥1 point, plus either a ≥1-point decrease in RBS or an RBS of 0 or 1.	Week 12 and 24 after randomization
Number of remission-relapse episodes	Incidence of clinical recurrences(defined per STRIDE-II consensus) within 24 weeks post-randomization.	Week 24 after randomization
Time to first relapse	Time to first relapse within 24 weeks post-randomization	Week 24 after randomization
Use of rescue medication	Proportion of patients requiring glucocorticoids, immunosuppressants, biologics, or other rescue medications due to disease progression.	Week 24 after randomization
Change in Nancy Histological Index score	Change from baseline in the Nancy Histological Index score, a validated scale for assessing histological disease activity in ulcerative colitis, with scores ranging from 0 (no activity) to 3 (severe activity). A higher score indicates more severe histological inflammation.	Week 13-16 after randomization
Change in fecal calprotectin level	Change from baseline in fecal calprotectin concentration	Baseline, Week 12, Week 24
Change in C-reactive protein level	Change from baseline in serum C-reactive protein (CRP) concentration.	Baseline, Week 12, Week 24
Change in erythrocyte sedimentation rate	Change from baseline in erythrocyte sedimentation rate (ESR).	Baseline, Week 12, Week 24
Change in hemoglobin level	Change from baseline in hemoglobin (Hb) concentration.	Baseline, Week 12, Week 24
Change in Inflammatory Bowel Disease Questionnaire (IBDQ) score	Change from baseline in the total score of the Inflammatory Bowel Disease Questionnaire (IBDQ). The IBDQ is a 32-item questionnaire measuring quality of life in IBD patients, with total scores ranging from 32 to 224. A higher score indicates a better quality of life.	Baseline, Week 12, Week 24
Change in Pittsburgh Sleep Quality Index (PSQI) score	Change from baseline in the global score of the Pittsburgh Sleep Quality Index (PSQI). The PSQI assesses sleep quality over a 1-month interval, with global scores ranging from 0 to 21. A higher score indicates worse sleep quality.	Baseline, Week 12, Week 24
Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) score	Change from baseline in the score of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) subscale. The FACIT-Fatigue is a 13-item subscale measuring fatigue, with scores ranging from 0 to 52. A higher score indicates less fatigue (better outcome).	Baseline, Week 12, Week 24
Change in Beck Depression Inventory-II (BDI-II) score	Change from baseline in the total score of the Beck Depression Inventory-II (BDI-II). The BDI-II is a 21-item self-report inventory measuring the severity of depression, with total scores ranging from 0 to 63. A higher score indicates more severe depressive symptoms.	Baseline, Week 12, Week 24
Change in Beck Anxiety Inventory (BAI) score	Change from baseline in the total score of the Beck Anxiety Inventory (BAI). The BAI is a 21-item self-report inventory measuring the severity of anxiety, with total scores ranging from 0 to 63. A higher score indicates more severe anxiety symptoms.	Baseline, Week 12, Week 24
De Qi sensation on the Massachusetts General Hospital Acupuncture Sensation Scale (MASS)	Score on the Massachusetts General Hospital Acupuncture Sensation Scale (MASS), a validated instrument assessing 12 sensations associated with De Qi (e.g., soreness, numbness, distension). The total score is a weighted sum, with a higher score indicating a more pronounced De Qi experience.	Week 12 after randomization
Change in Acupuncture Treatment Expectancy score	Change from baseline in the score of the Acupuncture Expectancy Scale (AES), a questionnaire assessing patients' belief in the potential benefit of acupuncture treatment. A higher score indicates greater treatment expectancy.	Baseline, Week 12 after randomization
Incidence of acupuncture-related adverse events	Number and percentage of participants experiencing any acupuncture-related adverse event (e.g., local hematoma, intense pain [VAS ≥8], infection) or other discomfort (e.g., nausea, dizziness) following each acupuncture session, assessed over the entire treatment period.	Throughout the 12-week treatment period
Change in abdominal symptoms severity score	Change from baseline in the severity of abdominal symptoms (including defecation urgency and abdominal pain) as assessed by a Numerical Rating Scale (NRS). The NRS is a self-report scale ranging from 0 ("no symptom") to 10 ("worst imaginable symptom"). A higher score indicates more severe symptoms.	Week 24 after randomization
Change in Patient-Doctor Relationship Questionnaire (PDRQ-9) score	Change from baseline in the total score of the Patient-Doctor Relationship Questionnaire (PDRQ-9). The PDRQ-9 is a 9-item questionnaire assessing the quality of the patient-doctor relationship, with total scores ranging from 9 to 45. A higher score indicates a better perceived relationship.	Baseline, Week 12, Week 24

Collaborators and Investigators

• Sponsor: Qin Yu
• Investigators: Principal Investigator: Yu Qin, Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: January 2, 2026
• First Submitted That Met QC Criteria: January 29, 2026
• First Posted (Actual): February 5, 2026

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: January 29, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Acupuncture; Ulcerative Colitis; Mesalazine
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; Organic Chemicals; Therapeutics; Hydrocarbons; Hydrocarbons, Cyclic; Complementary Therapies; Carboxylic Acids; Hydroxy Acids; Hydrocarbons, Aromatic; Phenols; Benzene Derivatives; Acids, Carbocyclic; Aminobenzoates; Benzoates; Salicylates; Hydroxybenzoates; meta-Aminobenzoates; Aminosalicylic Acids; Mesalamine; Acupuncture Therapy
• Other Study ID Numbers: UC-ACU(2025TJ01)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD after de-identification can be shared on individual request to the principal investigator at yuqin@tjh.tjmu.edu.cn
• IPD Sharing Time Frame: IPD and supporting information will be available after the publication of the primary outcomes
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No