Transcutaneous Electrical Acustimulation in the Treatment of Mild to Moderate Ulcerative Colitis
Not applicable · Testing transcutaneous electrical acustimulation at treatment sites · 4 sites · Xijing Hospital
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing transcutaneous electrical acustimulation at treatment sites (a device) as a possible treatment. Condition(s) listed: Ulcerative Colitis.
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is blinded: participants and the study team do not know who receives what.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- Age ≥18 years
- Ulcerative colitis diagnosed for at least 3 mouths.
- Mayo score 4-10, Mayo endoscopic score 2-3 points
Plus 1 more requirement(s). There are also 6 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 96 participants are expected to take part.
- Start date: 2024-01-19.
- Main results expected around 2026-03-01 (estimate from the record).
- 4 study sites listed (4 marked recruiting) in China.
Main thing being measured
- Clinical response (8 weeks)
In the researchers’ words
The aim of this study was to evaluate the efficacy and safety of transcutaneous electrical acustimulation in patients with mild to moderate ulcerative colitis.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Ulcerative Colitis |
| Lead sponsor | Xijing Hospital |
| Enrollment | 96 (estimated) |
| Start date | 2024-01-19 |
| Primary completion (est.) | 2026-03-01 |
| First posted | 2024-01-30 |
| Last updated | 2025-05-25 |
| Official title | A Multicenter Randomized Controlled Trial of Transcutaneous Electrical Acustimulation in the Treatment of Mild to Moderate Ulcerative Colitis |
| ClinicalTrials.gov ID | NCT06231264 |
Interventions
- transcutaneous electrical acustimulation at treatment sites (Device)
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 sites (Device)
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.
Full eligibility criteria (from the record)
Inclusion Criteria: 1. Age ≥18 years 2. Ulcerative colitis diagnosed for at least 3 mouths. 3. Mayo score 4-10, Mayo endoscopic score 2-3 points 4. Resistant to at least one type of medical treatments Exclusion Criteria: 1. Treatment-naive ulcerative colitis (no previous treatment) 2. Acute severe ulcerative colitis 3. Previous surgical treatment or severe colitis at imminent risk of surgery infective colitis 4. Other systemic diseases 5. Pregnancy and lactation 6. Allergic to the electrode patch
Locations (4)
| Site | City | Country | Site status |
|---|---|---|---|
| Honghui hospital | Xi'an, Shaanxi | China | Recruiting |
| Second Affiliated Hospital of Xi 'an Jiaotong University | Xi'an, Shaanxi | China | Recruiting |
| Tangdu Hospital | Xi'an, Shaanxi | China | Recruiting |
| Xijing Hospital | Xi'an, Shaanxi | China | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.