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

A

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

Trial contacts and locations

4

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Central trial contact

Jian Wan

Data sourced from clinicaltrials.gov

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