Ulcerative ColitisNCT06615765
Acupuncture for Symptom Relief in Adults with Mild to Moderate Ulcerative Colitis
A study testing Acupuncture in people with Ulcerative Colitis, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences.
Trial summary
Ulcerative colitis (UC) is one of the two primary forms of inflammatory bowel disease. This condition is characterized by continuous mucosal inflammation that begins in the rectum and extends proximally throughout the colon. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2024to 31 Oct 2026
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible participants are those aged 18 to 70 years who meet the diagnostic criteria for mild to moderate UC, have a PRO2 score of ≥ 2 points, and provide written informed consent. Patients currently receiving oral and/or topical 5-aminosalicylic acid (such as mesalamine) may continue their treatment during the study period.
Who cannot join
- Participants will be excluded if they meet any of the following criteria:
- Diagnosis of Crohn's disease, intestinal tuberculosis, chronic intestinal infections, or intestinal malignancies.
- Current treatment with corticosteroids, thiopurines, biologics, or oral small molecules.
- Severe skin conditions or infections.
- Presence of severe underlying medical conditions, including but not limited to cardiovascular diseases, hepatobiliary diseases, kidney diseases, hematologic disorders, autoimmune diseases, communicable diseases, severe malnutrition, or malignancies.
- Mental illness, cognitive dysfunction, or language disorders.
Show all 9Show fewer
- Receipt of acupuncture therapy for UC within the past month.
- Substance abuse issues.
- Pregnancy, plans to become pregnant within the next year, lactation, or being within 12 months postpartum.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy and Safety of Two-step Acupuncture Therapy for Symptom Relief in Adults with Mild to Moderate Ulcerative Colitis
Ulcerative colitis (UC) is one of the two primary forms of inflammatory bowel disease. This condition is characterized by continuous mucosal inflammation that begins in the rectum and extends proximally throughout the colon. Common intestinal symptoms also include rectal bleeding, increased stool frequency, tenesmus, nocturnal bowel movements, and crampy abdominal pain. Acupuncture has been suggested as a potential intervention to alleviate clinical symptoms of UC. This single-center, parallel-group, two-arm, randomized, sham-controlled trial aims to evaluate the effects and safety of acupuncture for UC.
Read the detailed description
Ulcerative colitis (UC) is a chronic inflammatory bowel disease characterized by episodes of symptoms including rectal bleeding, increase stool frequency, and abdominal pain, impacting quality of life significantly. Conventional treatments often come with potential side effects and may not be sufficient. Acupuncture is increasingly recognized for its promising benefits in UC. This study aims to assess the efficacy and safety of acupuncture for symptom relief in mild to moderate UC.This single-center, parallel-arm, randomized, sham-controlled trial will involve 64 patients with UC, randomly assigned in a 1:1 ratio to either the acupuncture or sham acupuncture group. Participants will receive 20 sessions of acupuncture or sham acupuncture over eight weeks. Blinding will be applied to participants, outcome assessors, and statisticians. The primary outcome measure is the change in Patient-Reported Outcome 2 (PRO2) from baseline at week 8. Secondary outcomes include changes from baseline in the following scales: PRO2 at other time points, weekly average Numeric Rating Scale (U-NRS) for bowel urgency, weekly average NRS for abdominal pain (both associated and not associated with bowel movement), the 32-item Inflammatory Bowel Disease Questionnaire (IBDQ-32), Work Productivity and Activity Impairment Questionnaire-Inflammatory Bowel Disease (WPAI-IBD), Pittsburgh Sleep Quality Index (PSQI), and Hospital Anxiety and Depression Scale (HADS). Patient Global Impression of Change (PGIC) will also be assessed as secondary outcomes. Adverse events and additional treatments will be monitored throughout the study. The modified intention-to-treat (mITT) population will include participants who complete baseline assessments and receive at least one treatment session.
- Conditions
- Ulcerative Colitis
- Being tested
- Acupuncture, Sham acupuncture
- Keywords
- Acupuncture, Ulcerative colitis, Patient-reported outcome 2, Inflammatory bowel disease, Randomized controlled trial
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
Acupuncture sessions will use sterile, disposable stainless-steel needles (0.3 mm × 40 mm and 0.3 mm × 75 mm). Each session has two phases:
Supine Position:
- Needles (0.35 mm × 75 mm) are inserted into ST25, ST15, and SP14, reaching the abdominal muscle layer.
- Needles (0.30 mm × 40 mm) are inserted into CV12, CV4, ST36, ST37, and SP6.
- Electroacupuncture (EA) at ST25, SP15, and ST36 uses a continuous 5 Hz wave, 0.1 to 2.0 mA.
Prone Position:
- Needles are inserted into BL32, BL33, and BL35 with precise angles and depths.
- EA at BL32, BL33, and BL35 uses a continuous 5 Hz wave, 2.0 to 6.5 mA. Sessions occur three times a week for the first 4 weeks, then twice a week for weeks 5 to 8, each lasting 40 minutes, totaling 20 sessions.
Sham acupunctureOther
Sterile, disposable stainless-steel needles (0.30 mm × 25 mm) will be used. After skin sterilization, needles will be inserted into the same points as the acupuncture group but to a shallow depth of 2 to 3 mm and lightly manipulated for blinding. Paired alligator clips will be attached to the same points, but the sham EA apparatus will have no current output, though it mimics the active EA apparatus in appearance and sound. Sham sessions will follow the same schedule as the acupuncture group: three times a week for the first 4 weeks and twice a week for weeks 5 to 8, each lasting 40 minutes, totaling 20 sessions.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture group | Experimental | Acupuncture sessions will use sterile, disposable stainless-steel needles (0.3 mm × 40 mm and 0.3 mm × 75 mm). Each session has two phases:
Supine Position:
Needles (0.35 mm × 75 mm) are inserted into ST25, ST15, and SP14, reaching the abdominal muscle layer.
Needles (0.30 mm × 40 mm) are inserted into CV12, CV4, ST36, ST37, and SP6. Electroacupuncture (EA) at ST25, SP15, and ST36 uses a continuous 5 Hz wave, 0.1 to 2.0 mA.
Prone Position:
Needles are inserted into BL32, BL33, and BL35 with precise angles and depths. EA at BL32, BL33, and BL35 uses a continuous 5 Hz wave, 2.0 to 6.5 mA. Sessions occur three times a week for the first 4 weeks, then twice a week for weeks 5 to 8, each lasting 40 minutes, totaling 20 sessions. Receives: Other: Acupuncture |
| Sham acupuncture group | Sham comparator | Sterile, disposable stainless-steel needles (0.30 mm × 25 mm) will be used. After skin sterilization, needles will be inserted into the same points as the acupuncture group but to a shallow depth of 2 to 3 mm and lightly manipulated for blinding. Paired alligator clips will be attached to the same points, but the sham EA apparatus will have no current output, though it mimics the active EA apparatus in appearance and sound. Sham sessions will follow the same schedule as the acupuncture group: three times a week for the first 4 weeks and twice a week for weeks 5 to 8, each lasting 40 minutes, totaling 20 sessions. Receives: Other: Sham acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in the PRO2 score
Data on daily bowel movements and rectal bleeding will be summarized from the stool diaries. The PRO2 score, assessed at weeks 4, 8, 12, 16, 20, 24, 28, and 32, comprises the Stool Frequency (SF) and Rectal Bleeding (RB) subscales of the Mayo score. The SF subscale is rated as follows: 0 (normal stool frequency), 1 (1-2 stools more than normal), 2 (3-4 stools more than normal), and 3 (5 or more stools more than normal). The RB subscale is rated as: 0 (no blood), 1 (streaks of blood less than half the time), 2 (obvious blood most of the time), and 3 (blood alone). The primary outcome is the change from baseline in the PRO2 score at week 8.
Measured: Week 8 after randomization
Secondary outcomes (11)
The proportion of patients achieving a ≥ 50% reduction in PRO2 score at weeks 4, 8, 12, 16, 20, 24, 28, and 32.
Measured: Weeks 4, 8, 12, 16, 20, 24, 28, and 32 after randomization.
The proportion of patients with a PRO2 score of 0
Measured: At weeks 4, 8, 12, 16, 20, 24, 28, and 32 after randomization.
Changes from baseline in weekly average U-NRS scores
Since bowel urgency is an independent and critical symptom impacting patients' quality of life and productivity, this study will assess bowel urgency severity using the Numeric Rating Scale (U-NRS) (0 = no urgency, 10 = worst possible urgency). The minimal clinically important difference (MCID) is defined as a ≥3-point decrease in U-NRS from baseline, while bowel urgency remission is defined as a U-NRS score of 0 or 1. In this study, patients will be instructed to record their scores for each bowel movement. The average U-NRS score will be calculated weekly by summing the U-NRS scores for the week and dividing by the total number of bowel movements.
Measured: At weeks 4, 8, 12, 16, 20, 24, 28, and 32 after randomization.
Changes from baseline in weekly average NRS scores for abdominal pain associated with bowel movements
For the NRS score related to abdominal pain associated with bowel movements (scale 0 to 10, with higher scores indicating more severe pain), patients will record their scores for each bowel movement. The weekly average NRS score will be derived by summing these scores and dividing by the total number of bowel movements.
Measured: At weeks 4, 8, 12, 16, 20, 24, 28, and 32 after randomization.
Changes from baseline in weekly average NRS scores for abdominal pain not associated with bowel movements
For the NRS score related to abdominal pain not associated with bowel movements (scale 0 to 10, with higher scores indicating more severe pain), patients will record daily scores, which will then be summed over the week and divided by 7 to obtain the weekly average NRS score.
Measured: At weeks 4, 8, 12, 16, 20, 24, 28, and 32 after randomization.
Changes from baseline in IBDQ-32 scores
The IBDQ-32 is the predominant tool for assessing disease-specific quality of life in randomized clinical trials for UC. Studies support the efficacy of IBDQ-32 in capturing treatment impacts on the quality of life of UC patients. The questionnaire encompasses four domains reflecting the impact of UC on patients: symptoms, psychological and social functioning, and physical and emotional well-being.
Measured: At weeks 4, 8, 12, 20, and 32 after randomization.
Changes from baseline in WPAI-IBD scores
The WPAI-IBD (version 2.0) (www.reillyassociates.net), is a validated tool designed to assess impairments in work and daily activities. This 6-item questionnaire evaluates impairments experienced over the past 7 days and provides four key metrics: 1) Absenteeism (percentage of work time missed); 2) Presenteeism (percentage of impairment while at work); 3) Overall work productivity loss (combined estimate of absenteeism and presenteeism); and 4) Activity impairment (percentage of impairment in daily activities). WPAI-IBD results are reported as percentages, with higher scores reflecting greater impairment and reduced productivity.
Measured: At weeks 4, 8, 20, and 32 after randomization.
Changes from baseline in PSQI scores
The Pittsburgh Sleep Quality Index (PSQI) is a self-administered questionnaire that assesses sleep quality and disturbances over the past month, with higher scores indicating worse sleep quality.
Measured: At weeks 8, 20, and 32 after randomization.
Changes from baseline in HADS scores
The Hospital Anxiety and Depression Scale (HADS) is a self-report tool designed to identify symptoms of depression and anxiety, with higher scores reflecting more severe symptoms.
Measured: At weeks 8, 20, and 32 after randomization.
PGIC
The Patient Global Impression of Change (PGIC) will be used to evaluate overall improvement. This simple, patient-reported outcome measures participants\' perceptions of changes in their condition using a 7-point scale: "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse."
Measured: At weeks 4, 8, 20, and 32 after randomization.
Changes from baseline in the PRO2 score
Data on daily bowel movements and rectal bleeding will be summarized from the stool diaries. The PRO2 score, assessed at weeks 4, 8, 12, 16, 20, 24, 28, and 32, comprises the Stool Frequency (SF) and Rectal Bleeding (RB) subscales of the Mayo score. The SF subscale is rated as follows: 0 (normal stool frequency), 1 (1-2 stools more than normal), 2 (3-4 stools more than normal), and 3 (5 or more stools more than normal). The RB subscale is rated as: 0 (no blood), 1 (streaks of blood less than half the time), 2 (obvious blood most of the time), and 3 (blood alone).
Measured: Weeks 4, 12, 16, 20, 24, 28, and 32 after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start1 Nov 2024 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, He Chen, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06615765
- Sponsor's protocol ID
- 2024-190-KY
- Status last verified
- Sep 2024
- First submitted
- 22 Sep 2024
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen H, Fang J, Liu S, Gao S, Shi H, Ma JZ, Shen X, Wang W, Liu Z. Efficacy and safety of two-step acupuncture therapy for symptom relief in adults with mild to moderate ulcerative colitis: rationale and design of the TSA-UC randomised controlled trial. BMJ Open. 2025 Feb 27;15(2):e094301. doi: 10.1136/bmjopen-2024-094301.
PubMed 40021194
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Two-step Acupuncture Therapy for Symptom Relief in Adults with Mild to Moderate Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT06615765
- Acronym / sponsor ID
- 2024-190-KY
- Conditions
- Ulcerative Colitis
- Keywords
- Acupuncture, Ulcerative colitis, Patient-reported outcome 2, Inflammatory bowel disease, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 27 Sep 2024 (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.
Ulcerative colitis (UC) is one of the two primary forms of inflammatory bowel disease. This condition is characterized by continuous mucosal inflammation that begins in the rectum and extends proximally throughout the colon. Common intestinal symptoms also include rectal bleeding, increased stool frequency, tenesmus, nocturnal bowel movements, and crampy abdominal pain. Acupuncture has been suggested as a potential intervention to alleviate clinical symptoms of UC. This single-center, parallel-group, two-arm, randomized, sham-controlled trial aims to evaluate the effects and safety of acupuncture for UC.
Detailed description
Ulcerative colitis (UC) is a chronic inflammatory bowel disease characterized by episodes of symptoms including rectal bleeding, increase stool frequency, and abdominal pain, impacting quality of life significantly. Conventional treatments often come with potential side effects and may not be sufficient. Acupuncture is increasingly recognized for its promising benefits in UC. This study aims to assess the efficacy and safety of acupuncture for symptom relief in mild to moderate UC.This single-center, parallel-arm, randomized, sham-controlled trial will involve 64 patients with UC, randomly assigned in a 1:1 ratio to either the acupuncture or sham acupuncture group. Participants will receive 20 sessions of acupuncture or sham acupuncture over eight weeks. Blinding will be applied to participants, outcome assessors, and statisticians. The primary outcome measure is the change in Patient-Reported Outcome 2 (PRO2) from baseline at week 8. Secondary outcomes include changes from baseline in the following scales: PRO2 at other time points, weekly average Numeric Rating Scale (U-NRS) for bowel urgency, weekly average NRS for abdominal pain (both associated and not associated with bowel movement), the 32-item Inflammatory Bowel Disease Questionnaire (IBDQ-32), Work Productivity and Activity Impairment Questionnaire-Inflammatory Bowel Disease (WPAI-IBD), Pittsburgh Sleep Quality Index (PSQI), and Hospital Anxiety and Depression Scale (HADS). Patient Global Impression of Change (PGIC) will also be assessed as secondary outcomes. Adverse events and additional treatments will be monitored throughout the study. The modified intention-to-treat (mITT) population will include participants who complete baseline assessments and receive at least one treatment session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture group | Experimental | Other: AcupunctureAcupuncture sessions will use sterile, disposable stainless-steel needles (0.3 mm × 40 mm and 0.3 mm × 75 mm). Each session has two phases: Supine Position: Needles (0.35 mm × 75 mm) are inserted into ST25, ST15, and SP14, reaching the abdominal muscle layer. Needles (0.30 mm × 40 mm) are inserted into CV12, CV4, ST36, ST37, and SP6. Electroacupuncture (EA) at ST25, SP15, and ST36 uses a continuous 5 Hz wave, 0.1 to 2.0 mA. Prone Position: Needles are inserted into BL32, BL33, and BL35 with precise angles and depths. EA at BL32, BL33, and BL35 uses a continuous 5 Hz wave, 2.0 to 6.5 mA. Sessions occur three times a week for the first 4 weeks, then twice a week for weeks 5 to 8, each lasting 40 minutes, totaling 20 sessions. |
| Sham acupuncture group | Sham comparator | Other: Sham acupunctureSterile, disposable stainless-steel needles (0.30 mm × 25 mm) will be used. After skin sterilization, needles will be inserted into the same points as the acupuncture group but to a shallow depth of 2 to 3 mm and lightly manipulated for blinding. Paired alligator clips will be attached to the same points, but the sham EA apparatus will have no current output, though it mimics the active EA apparatus in appearance and sound. Sham sessions will follow the same schedule as the acupuncture group: three times a week for the first 4 weeks and twice a week for weeks 5 to 8, each lasting 40 minutes, totaling 20 sessions. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible participants are those aged 18 to 70 years who meet the diagnostic criteria for mild to moderate UC, have a PRO2 score of ≥ 2 points, and provide written informed consent. Patients currently receiving oral and/or topical 5-aminosalicylic acid (such as mesalamine) may continue their treatment during the study period.
Key exclusion criteria (9 listed)
- Diagnosis of Crohn's disease, intestinal tuberculosis, chronic intestinal infections, or intestinal malignancies.
- Current treatment with corticosteroids, thiopurines, biologics, or oral small molecules.
- Severe skin conditions or infections.
- Presence of severe underlying medical conditions, including but not limited to cardiovascular diseases, hepatobiliary diseases, kidney diseases, hematologic disorders, autoimmune diseases, communicable diseases, severe malnutrition, or malignancies.
- Mental illness, cognitive dysfunction, or language disorders.
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 |
|---|---|---|
| AcupunctureAcupuncture sessions will use sterile, disposable stainless-steel needles (0.3 mm × 40 mm and 0.3 mm × 75 mm). Each session has two phases: Supine Position: * Needles (0.35 mm × 75 mm) are inserted into ST25, ST15, and SP14, reaching the abdominal muscle layer. * Needles (0.30 mm × 40 mm) are inserted into CV12, CV4, ST36, ST37, and SP6. * Electroacupuncture (EA) at ST25, SP15, and ST36 uses a continuous 5 Hz wave, 0.1 to 2.0 mA. Prone Position: * Needles are inserted into BL32, BL33, and BL35 with precise angles and depths. * EA at BL32, BL33, and BL35 uses a continuous 5 Hz wave, 2.0 to 6.5 mA. Sessions occur three times a week for the first 4 weeks, then twice a week for weeks 5 to 8, each lasting 40 minutes, totaling 20 sessions. | Other | Acupuncture group |
| Sham acupunctureSterile, disposable stainless-steel needles (0.30 mm × 25 mm) will be used. After skin sterilization, needles will be inserted into the same points as the acupuncture group but to a shallow depth of 2 to 3 mm and lightly manipulated for blinding. Paired alligator clips will be attached to the same points, but the sham EA apparatus will have no current output, though it mimics the active EA apparatus in appearance and sound. Sham sessions will follow the same schedule as the acupuncture group: three times a week for the first 4 weeks and twice a week for weeks 5 to 8, each lasting 40 minutes, totaling 20 sessions. | Other | Sham acupuncture group |
Primary outcome
change from baseline in the PRO2 score
Time frame: Week 8 after randomization
Data on daily bowel movements and rectal bleeding will be summarized from the stool diaries. The PRO2 score, assessed at weeks 4, 8, 12, 16, 20, 24, 28, and 32, comprises the Stool Frequency (SF) and Rectal Bleeding (RB) subscales of the Mayo score. The SF subscale is rated as follows: 0 (normal stool frequency), 1 (1-2 stools more than normal), 2 (3-4 stools more than normal), and 3 (5 or more stools more than normal). The RB subscale is rated as: 0 (no blood), 1 (streaks of blood less than half the time), 2 (obvious blood most of the time), and 3 (blood alone). The primary outcome is the change from baseline in the PRO2 score at week 8.
11 secondary outcomes
The proportion of patients achieving a ≥ 50% reduction in PRO2 score at weeks 4, 8, 12, 16, 20, 24, 28, and 32.
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, and 32 after randomization.
The proportion of patients with a PRO2 score of 0
Time frame: At weeks 4, 8, 12, 16, 20, 24, 28, and 32 after randomization.
Changes from baseline in weekly average U-NRS scores
Time frame: At weeks 4, 8, 12, 16, 20, 24, 28, and 32 after randomization.
Changes from baseline in weekly average NRS scores for abdominal pain associated with bowel movements
Time frame: At weeks 4, 8, 12, 16, 20, 24, 28, and 32 after randomization.
Changes from baseline in weekly average NRS scores for abdominal pain not associated with bowel movements
Time frame: At weeks 4, 8, 12, 16, 20, 24, 28, and 32 after randomization.
Changes from baseline in IBDQ-32 scores
Time frame: At weeks 4, 8, 12, 20, and 32 after randomization.
Changes from baseline in WPAI-IBD scores
Time frame: At weeks 4, 8, 20, and 32 after randomization.
Changes from baseline in PSQI scores
Time frame: At weeks 8, 20, and 32 after randomization.
Changes from baseline in HADS scores
Time frame: At weeks 8, 20, and 32 after randomization.
PGIC
Time frame: At weeks 4, 8, 20, and 32 after randomization.
Changes from baseline in the PRO2 score
Time frame: Weeks 4, 12, 16, 20, 24, 28, and 32 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 27 Sep 2024.
- Derived from this study: PubMed 40021194Chen H, Fang J, Liu S, Gao S, Shi H, Ma JZ, Shen X, Wang W, Liu Z. Efficacy and safety of two-step acupuncture therapy for symptom relief in adults with mild to moderate ulcerative colitis: rationale and design of the TSA-UC randomised controlled trial. BMJ Open. 2025 Feb 27;15(2):e094301. doi: 10.1136/bmjopen-2024-094301.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Ulcerative Colitis, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences.
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 1 inclusion and 9 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: opening soon, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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 He Chen, bachelor of medicine (+86 19927523321, chenhenick@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline in the PRO2 score (time frame: Week 8 after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06615765, which also lists 1 linked publication.
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 27 Sep 2024; AzTrials last refreshed its copy on 7 Nov 2026.