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Study on the brain network mechanism of transcutaneous auricular vagus nerve stimulation in the treatment of ulcerative colitis based on functional magnetic resonance imaging

Phase 1
Conditions
lcerative colitis
Registration Number
ITMCTR2200005997
Lead Sponsor
Wangjing Hospital, Chinese Academy of Traditional Chinese Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

Patients who meet the following six items must also be included in this study:

(1) There are colonoscopy and pathological diagnosis reports of tertiary hospitals that meet the diagnostic criteria for ulcerative colitis;

(2) The lesions range from rectum (E1) or left colon (E2) or total colon type (E3);

(3) Mayo defecation score or bloody stool score of 1 or 2 points, and the disease activity is mild and moderate;

(4) Those between the ages of 18 and 70;

(5) Subjects should only take mesalazine before entering the group;

(6) Voluntary examination and I will sign the informed consent form.
Criteria for the diagnosis of Ulcerative Colitis: According to ACG Clinical Guideline: Ulcerative Colitis in Adults, the diagnosis should be made based on the exclusion of infectious and non-infectious Colitis by comprehensive analysis of Clinical manifestations, endoscopy, and histopathology.

Exclusion Criteria

Patients who meet one or more of the following items shall be excluded:

(1) Those with serious complications, such as local stenosis, intestinal obstruction, intestinal perforation, toxic megacolon, rectal cancer, colon cancer and anal diseases;

(2) Women who are pregnant or preparing for pregnancy and lactating women;

(3) Patients with severe primary diseases such as liver, kidney, hematopoietic system and endocrine system and psychosis;

(4) Suspected or do have a history of alcohol, drug abuse and mental patients;

(5) According to the judgment of the researcher, it is not suitable to participate in this researcher;

(6) Patients involved in other body surface electrical stimulation or acupuncture therapy in the original treatment plan;

(7) Patients with skin lesions such as ulcer in the ear.

(8) Known patients with amino salicylic acid allergies.

(9) Patients who have been diagnosed with anxiety or depression before the diagnosis of ulcer colitis.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Concentration of fecal calcium sanitrin;Mayo defecation count rating;Mayo bloody stool score;heart rate variability;Brain function magnetic resonance data acquisition;Serum inflammatory cytokines;
Secondary Outcome Measures
NameTimeMethod
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