Transcutaneous Electrical Acustimulation in the Treatment of Mild to Moderate Ulcerative Colitis

NCT ID: NCT06231264

Last Updated: 2025-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-19

Study Completion Date

2026-05-01

Brief Summary

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The aim of this study was to evaluate the efficacy and safety of transcutaneous electrical acustimulation in patients with mild to moderate ulcerative colitis.

Detailed Description

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Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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treatment group

Subjects will be trained to use the devices at the treatment sites and receive treatment twice a day for 8 weeks.

Group Type EXPERIMENTAL

transcutaneous electrical acustimulation at treatment sites

Intervention Type 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.

shame group

Subjects will be trained to use the devices at the sham sites and receive sham treatment twice a day for 8 weeks.

Group Type PLACEBO_COMPARATOR

transcutaneous electrical acustimulation at sham sites

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

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TEA sham-TEA

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kaichun Wu

Role: PRINCIPAL_INVESTIGATOR

Xijing Hospital

Locations

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Honghui hospital

Xi'an, Shaanxi, China

Site Status RECRUITING

Second Affiliated Hospital of Xi 'an Jiaotong University

Xi'an, Shaanxi, China

Site Status RECRUITING

Tangdu Hospital

Xi'an, Shaanxi, China

Site Status RECRUITING

Xijing Hospital

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jian Wan

Role: CONTACT

+8615529202305

Facility Contacts

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Shuang Han

Role: primary

Sumei Sha

Role: primary

Ning Wang

Role: primary

Jian Wan

Role: primary

+8615529202305

Other Identifiers

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KY20232371

Identifier Type: -

Identifier Source: org_study_id

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