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Study on the efficacy and mechanism of transcutaneous auricular vagus nerve stimulation in the treatment of mild to moderate ulcerative colitis

Study on the efficacy and mechanism of transcutaneous auricular vagus nerve stimulation in the treatment of mild to moderate ulcerative colitis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070493
Enrollment
Unknown
Registered
2023-04-13
Start date
2023-05-01
Completion date
Unknown
Last updated
2023-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

mild to moderate ulcerative colitis

Interventions

Experimental group:Mesalazine combined with percutaneous auricular vagus nerve stimulation
Control group:Mesalazine combined with sham transcutaneous ear vagus nerve stimulation

Sponsors

Anhui Provincial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients meeting UC (mild to moderate) diagnostic criteria; 2. Aged range from 18 to 65 years, gender is not limited; 3. Voluntarily accept the drug treatment, and sign the informed consent, and the informed consent process complies with relevant provisions of GCP.

Exclusion criteria

Exclusion criteria: 1. Patients with cardiovascular, cerebrovascular, liver, kidney, hematopoietic system diseases, hyperthyroidism, diabetes and other serious primary diseases, or serious diseases affecting their survival (such as tumors) and psychiatric patients; 2. Patients who are pregnant or planning to be pregnant or lactating; 3. Suspected or confirmed history of alcohol and drug abuse; 4. Those with cognitive dysfunction who cannot give adequate informed consent; 5. Patients who have participated in other clinical trials within the last 1 month; 6. Patients who have had abdominal surgery within 6 months; 7. Patients with general or specific contraindications to the physical therapy provided; 8. Patients with factors deemed unsuitable for inclusion by the investigator.

Design outcomes

Primary

MeasureTime frame
Visual Analogue Scale/Score;Bristol Stool Characterization Scale;Serum neurotransmitter levels;Inflammatory indicators;Intestinal flora;

Secondary

MeasureTime frame
Autonomic function;Vital signs;Adverse effects;

Countries

China

Contacts

Public ContactYu Yue

Anhui Provincial Hospital

yuyuemd@163.com+86 18755196560

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026