Ulcerative ColitisNCT07389824
Efficacy of Acupuncture-Mesalazine Combination Therapy in Ulcerative Colitis.
A study testing Acupuncture and Mesalazine in people with Ulcerative Colitis, run by Qin Yu at 1 site in China.
Trial summary
This study aims to evaluate the efficacy and safety of acupuncture combined with mesalazine (an integrated acupuncture-medication regimen) for ulcerative colitis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Acupuncture and Mesalazine
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)；
- Willing to undergo two colonoscopies (pre-treatment and post-treatment)；
- complete all baseline assessments;
- capable of understanding and voluntarily sign the informed consent form.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Yu Qin, 027-83665532, yuqin@tjh.tjmu.edu.cn
About this study
Official 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.
This study aims to evaluate the efficacy and safety of acupuncture combined with mesalazine (an integrated acupuncture-medication regimen) for ulcerative colitis.
Read the detailed description
- 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.
- Conditions
- Ulcerative Colitis
- Being tested
- Acupuncture, Sham acupuncture, Mesalazine
- Keywords
- Acupuncture, Mesalazine, Ulcerative Colitis
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureDevice
Also called Acupuncture with intradermal thumbtack needle
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 acupunctureDevice
Also called Sham acupuncture with sham intradermal thumbtack needle
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.
MesalazineDrug
Also called 5-ASA, 5-aminosalicylic acid
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sham acupuncture; Drug: Mesalazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 13-16 after randomization
Secondary outcomes (23)
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
Measured: 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.
Measured: Week 13-16 after randomization
Endoscopic remission (normalization) rate
Proportion of patients with a Mayo Endoscopic Subscore (MES) of 0.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Week 24 after randomization
Time to first relapse
Time to first relapse within 24 weeks post-randomization
Measured: Week 24 after randomization
Use of rescue medication
Proportion of patients requiring glucocorticoids, immunosuppressants, biologics, or other rescue medications due to disease progression.
Measured: 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 4 (severe activity). A higher score indicates more severe histological inflammation.
Measured: Week 13-16 after randomization
Change in fecal calprotectin level
Change from baseline in fecal calprotectin concentration
Measured: Baseline, Week 12, Week 24
Change in C-reactive protein level
Change from baseline in serum C-reactive protein (CRP) concentration.
Measured: Baseline, Week 12, Week 24
Change in erythrocyte sedimentation rate
Change from baseline in erythrocyte sedimentation rate (ESR).
Measured: Baseline, Week 12, Week 24
Change in hemoglobin level
Change from baseline in hemoglobin (Hb) concentration.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 12 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.
Measured: Baseline, Week 12 after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start1 Feb 2026
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to one of two parallel groups in a 1:1 ratio.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qin Yu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qin Yu, Tongji Hospital
- Investigators
- Yu Qin, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07389824
- Sponsor's protocol ID
- UC-ACU(2025TJ01)
- Status last verified
- Aug 2026
- First submitted
- 2 Jan 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD after de-identification can be shared on individual request to the principal investigator at yuqin@tjh.tjmu.edu.cn
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT07389824
- Acronym / sponsor ID
- UC-ACU(2025TJ01)
- Conditions
- Ulcerative Colitis
- Keywords
- Acupuncture, Mesalazine, Ulcerative Colitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Qin YuUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the efficacy and safety of acupuncture combined with mesalazine (an integrated acupuncture-medication regimen) for ulcerative colitis.
Detailed description
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to one of two parallel groups in a 1:1 ratio.
| Arm | Type | Receives |
|---|---|---|
| Verum acupuncture | Experimental | Device: Acupuncture, Drug: MesalazineParticipants 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. |
| sham acupuncture | Sham comparator | Device: Sham acupuncture, Drug: MesalazineParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)；
- Willing to undergo two colonoscopies (pre-treatment and post-treatment)；
Key exclusion criteria (12 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureAlso: Acupuncture with intradermal thumbtack needleIntradermal 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. | Device | Verum acupuncture |
| Sham acupunctureAlso: Sham acupuncture with sham intradermal thumbtack needleApplication 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. | Device | sham acupuncture |
| MesalazineAlso: 5-ASA, 5-aminosalicylic acidStandard 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. | Drug | Verum acupuncture, sham acupuncture |
Primary outcome
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.
23 secondary outcomes
Clinical response rate
Time frame: Week 13-16 after randomization
Endoscopic improvement rate
Time frame: Week 13-16 after randomization
Endoscopic remission (normalization) rate
Time frame: Week 13-16 after randomization
Symptomatic remission rate
Time frame: Week 12 and 24 after randomization
Symptomatic response rate
Time frame: Week 12 and 24 after randomization
Number of remission-relapse episodes
Time frame: Week 24 after randomization
Time to first relapse
Time frame: Week 24 after randomization
Use of rescue medication
Time frame: Week 24 after randomization
Change in Nancy Histological Index score
Time frame: Week 13-16 after randomization
Change in fecal calprotectin level
Time frame: Baseline, Week 12, Week 24
Change in C-reactive protein level
Time frame: Baseline, Week 12, Week 24
Change in erythrocyte sedimentation rate
Time frame: Baseline, Week 12, Week 24
Change in hemoglobin level
Time frame: Baseline, Week 12, Week 24
Change in Inflammatory Bowel Disease Questionnaire (IBDQ) score
Time frame: Baseline, Week 12, Week 24
Change in Pittsburgh Sleep Quality Index (PSQI) score
Time frame: Baseline, Week 12, Week 24
Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) score
Time frame: Baseline, Week 12, Week 24
Change in Beck Depression Inventory-II (BDI-II) score
Time frame: Baseline, Week 12, Week 24
Change in Beck Anxiety Inventory (BAI) score
Time frame: Baseline, Week 12, Week 24
De Qi sensation on the Massachusetts General Hospital Acupuncture Sensation Scale (MASS)
Time frame: Week 12 after randomization
Change in Acupuncture Treatment Expectancy score
Time frame: Baseline, Week 12 after randomization
Incidence of acupuncture-related adverse events
Time frame: Throughout the 12-week treatment period
Change in abdominal symptoms severity score
Time frame: Week 12 after randomization
Change in Patient-Doctor Relationship Questionnaire (PDRQ-9) score
Time frame: Baseline, Week 12 after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: Yes. IPD after de-identification can be shared on individual request to the principal investigator at yuqin@tjh.tjmu.edu.cn
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yu Qin principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture and Mesalazine in people with Ulcerative Colitis, run by Qin Yu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhou Pu (02783663625, tongjihlunli@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical remission rate (time frame: Week 13-16 after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.