Ulcerative Colitis Clinical Trial
Official title:
A Multicenter Randomized Controlled Trial of Transcutaneous Electrical Acustimulation in the Treatment of Mild to Moderate Ulcerative Colitis
Verified date | January 2024 |
Source | Xijing Hospital |
Contact | Jian Wan |
Phone | +8615529202305 |
408127528[@]qq.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study was to evaluate the efficacy and safety of transcutaneous electrical acustimulation in patients with mild to moderate ulcerative colitis.
Status | Recruiting |
Enrollment | 96 |
Est. completion date | March 1, 2025 |
Est. primary completion date | January 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | Honghui hospital | Xi'an | Shaanxi |
China | Second Affiliated Hospital of Xi 'an Jiaotong University | Xi'an | Shaanxi |
China | Tangdu Hospital | Xi'an | Shaanxi |
China | Xijing Hospital | Xi'an | Shaanxi |
Lead Sponsor | Collaborator |
---|---|
Xijing Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Change from baseline in the Mayo score | Mayo score at 8 week minus the Mayo score at baseline. The range of Mayo score is 0-12, and higher scores mean worse outcome. | 8 weeks | |
Secondary | Endoscopic remission | defined as Mayo endoscopic score = 1 | 8 weeks | |
Secondary | Clinical remission | overall score =2 [and no individual subscore >1] | 8 weeks | |
Secondary | Symptomatic remission | Stool frequence subscore = 0 (or = 1 with a = 1-point decrease from baseline) and rectal bleeding subscore = 0 | 2, 4, 6, and 8 weeks | |
Secondary | Fecal calprotectin | fecal sample | 4 and 8 weeks | |
Secondary | erythrocyte sedimentation rate | blood sample | 4 and 8 weeks | |
Secondary | C reactive protein | blood sample | 4 and 8 weeks | |
Secondary | pancreatic polypeptide | blood sample | 4 and 8 weeks | |
Secondary | norepinephrine | blood sample | 4 and 8 weeks | |
Secondary | acetyl choline | blood sample | 4 and 8 weeks | |
Secondary | acetyl choline | Intestinal mucosal tissue sample | 8 weeks | |
Secondary | alpha7 nicotinic acetylcholine receptor | Intestinal mucosal tissue sample | 8 weeks | |
Secondary | Inflammatory Bowel Disease Questionnaire Score | The range of Inflammatory Bowel Disease Questionnaire Score is 32-224, and higher scores mean worse outcome | 4 and 8 weeks | |
Secondary | Hospital Anxiety and Depression scale score | anxious depression. The range of Hospital Anxiety and Depression scale score is 0-21, and higher scores mean worse outcome. | 4 and 8 weeks | |
Secondary | Pittsburgh sleep quality index | The range of Pittsburgh sleep quality index is 0-21, and higher scores mean worse outcome. | 4 and 8 weeks | |
Secondary | autonomic profile characteristics | heart rate variability indicating sympathetic and parasympathetic activity | 4 and 8 weeks |
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