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NCT Number: NCT07389824

Efficacy of Acupuncture-Mesalazine Combination Therapy in Ulcerative Colitis.

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

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Wuhan, Hubei, 430030, China

Location contact

Yu Qin

CONTACT

[email protected]

027-83665532

About this study

  • A randomized controlled trial.
  • Acupuncture treatment(intradermal thumbtack needle embedding), placebo control.
  • To explore the efficacy and safety of acupuncture(intradermal thumbtack needles embedding) as an adjuvant therapy for active ulcerative colitis.
  • To explore the potential relevant mechanisms.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: Acupuncture with intradermal thumbtack needle

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.

Other names: Sham acupuncture with sham intradermal thumbtack needle

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.

Other names: 5-ASA, 5-aminosalicylic acid

Primary outcomes

  1. Clinical remission rate

    Time frame: Week 13-16 after randomization

    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.

Secondary outcomes

  1. Clinical response rate

    Time frame: Week 13-16 after randomization

    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

  2. Endoscopic improvement rate

    Time frame: Week 13-16 after randomization

    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.

  3. Endoscopic remission (normalization) rate

    Time frame: Week 13-16 after randomization

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

  4. Symptomatic remission rate

    Time frame: Week 12 and 24 after randomization

    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

  5. Symptomatic response rate

    Time frame: Week 12 and 24 after randomization

    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.

  6. Number of remission-relapse episodes

    Time frame: Week 24 after randomization

    Incidence of clinical recurrences(defined per STRIDE-II consensus) within 24 weeks post-randomization.

  7. Time to first relapse

    Time frame: Week 24 after randomization

    Time to first relapse within 24 weeks post-randomization

  8. Use of rescue medication

    Time frame: Week 24 after randomization

    Proportion of patients requiring glucocorticoids, immunosuppressants, biologics, or other rescue medications due to disease progression.

  9. Change in Nancy Histological Index score

    Time frame: Week 13-16 after randomization

    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.

  10. Change in fecal calprotectin level

    Time frame: Baseline, Week 12, Week 24

    Change from baseline in fecal calprotectin concentration

  11. Change in C-reactive protein level

    Time frame: Baseline, Week 12, Week 24

    Change from baseline in serum C-reactive protein (CRP) concentration.

  12. Change in erythrocyte sedimentation rate

    Time frame: Baseline, Week 12, Week 24

    Change from baseline in erythrocyte sedimentation rate (ESR).

  13. Change in hemoglobin level

    Time frame: Baseline, Week 12, Week 24

    Change from baseline in hemoglobin (Hb) concentration.

  14. Change in Inflammatory Bowel Disease Questionnaire (IBDQ) score

    Time frame: Baseline, Week 12, Week 24

    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.

  15. Change in Pittsburgh Sleep Quality Index (PSQI) score

    Time frame: Baseline, Week 12, Week 24

    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.

  16. Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) score

    Time frame: Baseline, Week 12, Week 24

    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).

  17. Change in Beck Depression Inventory-II (BDI-II) score

    Time frame: Baseline, Week 12, Week 24

    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.

  18. Change in Beck Anxiety Inventory (BAI) score

    Time frame: Baseline, Week 12, Week 24

    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.

  19. De Qi sensation on the Massachusetts General Hospital Acupuncture Sensation Scale (MASS)

    Time frame: Week 12 after randomization

    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.

  20. Change in Acupuncture Treatment Expectancy score

    Time frame: Baseline, Week 12 after randomization

    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.

  21. Incidence of acupuncture-related adverse events

    Time frame: Throughout the 12-week treatment period

    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.

  22. Change in abdominal symptoms severity score

    Time frame: Week 24 after randomization

    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.

  23. Change in Patient-Doctor Relationship Questionnaire (PDRQ-9) score

    Time frame: Baseline, Week 12, Week 24

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Zhou Pu

CONTACT

[email protected]

02783663625

Sponsors and collaborators

Lead sponsor

Qin Yu

Other

Registry information

Official study title

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.

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 5, 2026
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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