Ulcerative ColitisNCT06231264
Transcutaneous Electrical Acustimulation in the Treatment of Mild to Moderate Ulcerative Colitis
A study testing transcutaneous electrical acustimulation at treatment sites in people with Ulcerative Colitis, run by Xijing Hospital at 4 sites in China.
Trial summary
The aim of this study was to evaluate the efficacy and safety of transcutaneous electrical acustimulation in patients with mild to moderate ulcerative colitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- transcutaneous electrical acustimulation at treatment sites
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 4 sitesChina
- Study dates
- 19 Jan 2024to 1 May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Ulcerative colitis diagnosed for at least 3 mouths.
- Mayo score 4-10, Mayo endoscopic score 2-3 points
- Resistant to at least one type of medical treatments
Who cannot join
- Treatment-naive ulcerative colitis (no previous treatment)
- Acute severe ulcerative colitis
- Previous surgical treatment or severe colitis at imminent risk of surgery infective colitis
- Other systemic diseases
- Pregnancy and lactation
- Allergic to the electrode patch
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Honghui hospital
Xi'an, Shaanxi, 710000
Shuang Han
- Recruiting
Second Affiliated Hospital of Xi 'an Jiaotong University
Xi'an, Shaanxi, 710032
Sumei Sha
- Recruiting
Tangdu Hospital
Xi'an, Shaanxi, 710032
Ning Wang
- Recruiting
Xijing Hospital
Xi'an, Shaanxi, 710032
Jian Wan, +8615529202305, 408127528@qq.com
About this study
Official title: A Multicenter Randomized Controlled Trial of Transcutaneous Electrical Acustimulation in the Treatment of Mild to Moderate Ulcerative Colitis
The aim of this study was to evaluate the efficacy and safety of transcutaneous electrical acustimulation in patients with mild to moderate ulcerative colitis.
- Conditions
- Ulcerative Colitis
- Being tested
- transcutaneous electrical acustimulation at treatment sites, transcutaneous electrical acustimulation at sham sites
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous electrical acustimulation at treatment sitesDevice
Also called TEA
A transcutaneous electrical stimulator (TEA) device applies a mild electric stimulation through the skin, similar to acupuncture at the treatment site. The precise stimulating sites are not described upon registration to reduce unblinding risk.
transcutaneous electrical acustimulation at sham sitesDevice
Also called sham-TEA
A transcutaneous electrical stimulator (TEA) device applies a mild electric stimulation through the skin, similar to acupuncture at the sham treatment sites. The precise stimulating sites are not described upon registration to reduce unblinding risk.
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | Subjects will be trained to use the devices at the treatment sites and receive treatment twice a day for 8 weeks. Receives: Device: transcutaneous electrical acustimulation at treatment sites |
| shame group | Placebo comparator | Subjects will be trained to use the devices at the sham sites and receive sham treatment twice a day for 8 weeks. Receives: Device: transcutaneous electrical acustimulation at sham sites |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response
decrease of ≥3 points and ≥30% from baseline mayo score and decrease of ≥1 point in rectal bleeding subscore or absolute rectal bleeding subscore ≤ 1
Measured: 8 weeks
Secondary outcomes (16)
Change from baseline in the Mayo score
Mayo score at 8 week minus the Mayo score at baseline. The range of Mayo score is 0-12, and higher scores mean worse outcome.
Measured: 8 weeks
Endoscopic remission
defined as Mayo endoscopic score ≤ 1
Measured: 8 weeks
Clinical remission
overall score ≤2 [and no individual subscore >1]
Measured: 8 weeks
Symptomatic remission
Stool frequence subscore = 0 (or = 1 with a ≥ 1-point decrease from baseline) and rectal bleeding subscore = 0
Measured: 2, 4, 6, and 8 weeks
Fecal calprotectin
fecal sample
Measured: 4 and 8 weeks
erythrocyte sedimentation rate
blood sample
Measured: 4 and 8 weeks
C reactive protein
blood sample
Measured: 4 and 8 weeks
pancreatic polypeptide
blood sample
Measured: 4 and 8 weeks
norepinephrine
blood sample
Measured: 4 and 8 weeks
acetyl choline
blood sample
Measured: 4 and 8 weeks
acetyl choline
Intestinal mucosal tissue sample
Measured: 8 weeks
alpha7 nicotinic acetylcholine receptor
Intestinal mucosal tissue sample
Measured: 8 weeks
Inflammatory Bowel Disease Questionnaire Score
The range of Inflammatory Bowel Disease Questionnaire Score is 32-224, and higher scores mean worse outcome
Measured: 4 and 8 weeks
Hospital Anxiety and Depression scale score
anxious depression. The range of Hospital Anxiety and Depression scale score is 0-21, and higher scores mean worse outcome.
Measured: 4 and 8 weeks
Pittsburgh sleep quality index
The range of Pittsburgh sleep quality index is 0-21, and higher scores mean worse outcome.
Measured: 4 and 8 weeks
autonomic profile characteristics
heart rate variability indicating sympathetic and parasympathetic activity
Measured: 4 and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start19 Jan 2024
- Primary completion1 Mar 2026 (estimated)
- Study completion1 May 2026 (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.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- 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
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kaichun Wu, Principal investigator, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06231264
- Sponsor's protocol ID
- KY20232371
- Status last verified
- Jan 2025
- First submitted
- 10 Jan 2024
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Controlled Trial of Transcutaneous Electrical Acustimulation in the Treatment of Mild to Moderate Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT06231264
- Acronym / sponsor ID
- KY20232371
- Conditions
- Ulcerative Colitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 19 Jan 2024 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 30 Jan 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.
The aim of this study was to evaluate the efficacy and safety of transcutaneous electrical acustimulation in patients with mild to moderate ulcerative colitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Device: transcutaneous electrical acustimulation at treatment sitesSubjects will be trained to use the devices at the treatment sites and receive treatment twice a day for 8 weeks. |
| shame group | Placebo comparator | Device: transcutaneous electrical acustimulation at sham sitesSubjects will be trained to use the devices at the sham sites and receive sham treatment twice a day for 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years
- Ulcerative colitis diagnosed for at least 3 mouths.
- Mayo score 4-10, Mayo endoscopic score 2-3 points
- Resistant to at least one type of medical treatments
Key exclusion criteria (6 listed)
- Treatment-naive ulcerative colitis (no previous treatment)
- Acute severe ulcerative colitis
- Previous surgical treatment or severe colitis at imminent risk of surgery infective colitis
- Other systemic diseases
- Pregnancy and lactation
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 |
|---|---|---|
| transcutaneous electrical acustimulation at treatment sitesAlso: TEAA transcutaneous electrical stimulator (TEA) device applies a mild electric stimulation through the skin, similar to acupuncture at the treatment site. The precise stimulating sites are not described upon registration to reduce unblinding risk. | Device | treatment group |
| transcutaneous electrical acustimulation at sham sitesAlso: sham-TEAA transcutaneous electrical stimulator (TEA) device applies a mild electric stimulation through the skin, similar to acupuncture at the sham treatment sites. The precise stimulating sites are not described upon registration to reduce unblinding risk. | Device | shame group |
Primary outcome
Clinical response
Time frame: 8 weeks
decrease of ≥3 points and ≥30% from baseline mayo score and decrease of ≥1 point in rectal bleeding subscore or absolute rectal bleeding subscore ≤ 1
16 secondary outcomes
Change from baseline in the Mayo score
Time frame: 8 weeks
Endoscopic remission
Time frame: 8 weeks
Clinical remission
Time frame: 8 weeks
Symptomatic remission
Time frame: 2, 4, 6, and 8 weeks
Fecal calprotectin
Time frame: 4 and 8 weeks
erythrocyte sedimentation rate
Time frame: 4 and 8 weeks
C reactive protein
Time frame: 4 and 8 weeks
pancreatic polypeptide
Time frame: 4 and 8 weeks
norepinephrine
Time frame: 4 and 8 weeks
acetyl choline
Time frame: 4 and 8 weeks
acetyl choline
Time frame: 8 weeks
alpha7 nicotinic acetylcholine receptor
Time frame: 8 weeks
Inflammatory Bowel Disease Questionnaire Score
Time frame: 4 and 8 weeks
Hospital Anxiety and Depression scale score
Time frame: 4 and 8 weeks
Pittsburgh sleep quality index
Time frame: 4 and 8 weeks
autonomic profile characteristics
Time frame: 4 and 8 weeks
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 May 2025.
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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.
Kaichun Wu principal investigator
Xijing Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcutaneous electrical acustimulation at treatment sites in people with Ulcerative Colitis, run by Xijing Hospital at 4 sites 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 4 inclusion and 6 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 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 Jian Wan (+8615529202305, 408127528@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical response (time frame: 8 weeks). 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 May 2025.