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

Air Force Military Medical University of People's Liberation Army

Status: Enrolling

Conditions: Ulcerative Colitis

Treatments: Device: transcutaneous electrical acustimulation at sham sites; Device: transcutaneous electrical acustimulation at treatment sites

Study type: Interventional

Funder types: Other

Identifiers

NCT06231264

KY20232371

Details and patient eligibility

About

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

Enrollment: 96 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

96 participants in 2 patient groups, including a placebo group

treatment group

Experimental group

Description:

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

Treatment:

Device: transcutaneous electrical acustimulation at treatment sites

shame group

Placebo Comparator group

Description:

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

Treatment:

Device: transcutaneous electrical acustimulation at sham sites