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

NCT06231264 | Recruiting

• 1 other identifier: KY20232371
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Clinical response

  decrease of ≥3 points and ≥30% from baseline mayo score and decrease of ≥1 point in rectal bleeding subscore or absolute rectal bleeding subscore ≤ 1

  8 weeks

Secondary Outcomes (16)

• Change from baseline in the Mayo score

  8 weeks

• Endoscopic remission

  8 weeks

• Clinical remission

  8 weeks

• Symptomatic remission

  2, 4, 6, and 8 weeks

• Fecal calprotectin

  4 and 8 weeks

Study Arms (2)

treatment group

EXPERIMENTAL

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

Device: transcutaneous electrical acustimulation at treatment sites

shame group

PLACEBO COMPARATOR

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

Device: transcutaneous electrical acustimulation at sham sites

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.

Also known as: TEA

treatment group

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.

Also known as: sham-TEA

shame group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (4)

Honghui hospital

Xi'an, Shaanxi, 710000, China

RECRUITING

Second Affiliated Hospital of Xi 'an Jiaotong University

Xi'an, Shaanxi, 710032, China

RECRUITING

Tangdu Hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

Xijing Hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Kaichun Wu

  Xijing Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian Wan

CONTACT

+8615529202305; 408127528@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: January 30, 2024
• Study Start: January 19, 2024
• Primary Completion: March 1, 2026
• Study Completion: May 1, 2026
• Last Updated: May 25, 2025

Record last verified: 2025-01

Locations

CN (4)