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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06231264
Other study ID # KY20232371
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 19, 2024
Est. completion date March 1, 2025

Study information

Verified date January 2024
Source Xijing Hospital
Contact Jian Wan
Phone +8615529202305
Email 408127528@qq.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
transcutaneous electrical acustimulation at treatment sites
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.
transcutaneous electrical acustimulation at sham sites
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.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

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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