NCT Number: NCT06231264
The aim of this study was to evaluate the efficacy and safety of transcutaneous electrical acustimulation in patients with mild to moderate ulcerative colitis.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Honghui hospital, Xi'an, Shaanxi, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: TEA
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.
Other names: sham-TEA
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
Time frame: 8 weeks
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.
Time frame: 8 weeks
defined as Mayo endoscopic score ≤ 1
Time frame: 8 weeks
overall score ≤2 [and no individual subscore >1]
Time frame: 2, 4, 6, and 8 weeks
Stool frequence subscore = 0 (or = 1 with a ≥ 1-point decrease from baseline) and rectal bleeding subscore = 0
Time frame: 4 and 8 weeks
fecal sample
Time frame: 4 and 8 weeks
blood sample
Time frame: 4 and 8 weeks
blood sample
Time frame: 4 and 8 weeks
blood sample
Time frame: 4 and 8 weeks
blood sample
Time frame: 4 and 8 weeks
blood sample
Time frame: 8 weeks
Intestinal mucosal tissue sample
Time frame: 8 weeks
Intestinal mucosal tissue sample
Time frame: 4 and 8 weeks
The range of Inflammatory Bowel Disease Questionnaire Score is 32-224, and higher scores mean worse outcome
Time frame: 4 and 8 weeks
anxious depression. The range of Hospital Anxiety and Depression scale score is 0-21, and higher scores mean worse outcome.
Time frame: 4 and 8 weeks
The range of Pittsburgh sleep quality index is 0-21, and higher scores mean worse outcome.
Time frame: 4 and 8 weeks
heart rate variability indicating sympathetic and parasympathetic activity
Contact information is provided by the study sponsor or research team.
Xijing Hospital
Other
A Multicenter Randomized Controlled Trial of Transcutaneous Electrical Acustimulation in the Treatment of Mild to Moderate Ulcerative Colitis
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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