Transcutaneous Electrical Acustimulation in the Treatment of Mild to Moderate Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Official title:

A Multicenter Randomized Controlled Trial of Transcutaneous Electrical Acustimulation in the Treatment of Mild to Moderate Ulcerative Colitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06231264
• Other study ID #: KY20232371
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

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