Recruiting NCT06231264
Transcutaneous Electrical Acustimulation in the Treatment of Mild to Moderate Ulcerative Colitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: transcutaneous electrical acustimulation at treatment sites, transcutaneous electrical acustimulation at sham sites.
- Who it may be relevant to
- Registry conditions: Ulcerative Colitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Multicenter Randomized Controlled Trial of Transcutaneous Electrical Acustimulation in the Treatment of Mild to Moderate Ulcerative Colitis
Overview
The aim of this study was to evaluate the efficacy and safety of transcutaneous electrical acustimulation in patients with mild to moderate ulcerative colitis.
Interventions
- Device transcutaneous electrical acustimulation at treatment sites
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. - Device transcutaneous electrical acustimulation at sham sites
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.
Primary outcome measures
- Clinical response [Time frame: 8 weeks]
Secondary outcome measures (12)
- 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]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 4 centers
- Honghui hospital — Xi'an
- Second Affiliated Hospital of Xi 'an Jiaotong University — Xi'an
- Tangdu Hospital — Xi'an
- Xijing Hospital — Xi'an
Identifiers
NCT: NCT06231264 · KY20232371