NCT06231264
Recruiting
N/A
A Multicenter Randomized Controlled Trial of Transcutaneous Electrical Acustimulation in the Treatment of Mild to Moderate Ulcerative Colitis
Xijing Hospital4 sites in 1 country96 target enrollmentJanuary 19, 2024
ConditionsUlcerative Colitis
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Ulcerative Colitis
- Sponsor
- Xijing Hospital
- Enrollment
- 96
- Locations
- 4
- Primary Endpoint
- Clinical response
- Status
- Recruiting
- Last Updated
- 11 months ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Clinical response
Time Frame: 8 weeks
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
Secondary Outcomes
- Endoscopic remission(8 weeks)
- Fecal calprotectin(4 and 8 weeks)
- C reactive protein(4 and 8 weeks)
- pancreatic polypeptide(4 and 8 weeks)
- Change from baseline in the Mayo score(8 weeks)
- norepinephrine(4 and 8 weeks)
- Hospital Anxiety and Depression scale score(4 and 8 weeks)
- Clinical remission(8 weeks)
- erythrocyte sedimentation rate(4 and 8 weeks)
- Symptomatic remission(2, 4, 6, and 8 weeks)
- acetyl choline(8 weeks)
- Inflammatory Bowel Disease Questionnaire Score(4 and 8 weeks)
- Pittsburgh sleep quality index(4 and 8 weeks)
- alpha7 nicotinic acetylcholine receptor(8 weeks)
- autonomic profile characteristics(4 and 8 weeks)
Study Sites (4)
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