The Effect of Non-invasive Auricular Acupoint Stimulation on Slow Transmission Constipation

Phase 2

Not yet recruiting

• Conditions: Slow Transmission Constipation
• Interventions: Other: Auricular Acupoint Stimulation +prucapride; Drug: prucapride

• Registration Number: NCT06680882
• Lead Sponsor: The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Brief Summary

Objective To examine the therapeutic effect and safety of non-invasive auricular acupoint stimulation application on patients with slow transmission constipation.

Methods In a randomized clinical trial, 60 patients diagnosed with slow transit constipation (STC), ranging in age from 40 to 75 years, were allocated into two distinct cohorts: a study group and a control group. The study group, comprising 30 individuals, received a combination therapy of non-invasive auricular acupoint stimulation and prucapride, while the control group, also consisting of 30 patients, was administered prucapride as a monotherapy. To assess the efficacy of the interventions, various parameters were monitored, including serum levels of Neuropeptide Y (NPY), nitric oxide (NO), fecal water content, and gastrointestinal (GI) transit. The comparative therapeutic outcomes were determined by calculating symptom scores.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-06
• Study First Submitted QC: 2024-11-06
• Last Update Submitted: 2024-11-06
• Study Start: 2024-11-07
• Primary Completion: 2024-11-07
• Study First Posted: 2024-11-08
• Last Update Posted: 2024-11-08
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

① Conformity to the diagnostic benchmarks for STC as delineated in the Rome IV criteria; ② Absence of ingestion of any medication influencing gastrointestinal motility within the preceding three months; ③ Provision of informed consent after a comprehensive understanding of the study's objectives; ④ An age range of 40 to 75 years.

Exclusion Criteria

① Withdrawal from the therapeutic regimen; ② Auricle or ear canal pathologies; ③ Organic defecation disorder; ④ Pregnant or lactating.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study group	Auricular Acupoint Stimulation +prucapride	The study group, comprising 30 individuals, received a combination therapy of non-invasive auricular acupoint stimulation and prucapride
control group	prucapride	also consisting of 30 patients, was administered prucapride as a monotherapy.

Primary Outcome Measures

Name	Time	Method
overall efficacy rate	From enrollment to the end of treatment at one week	Symptoms were assessed both one week prior to and one week following treatment. The defecation time (scored as follows: 0 for ≤5 minutes; 1 for \>5 to ≤15 minutes; 2 for \>15 to ≤25 minutes; and 3 for \>25 minutes) and the inter defecation interval (scored as the number of hours divided by 24) were recorded. The efficacy index was calculated using the formula: \[(pretreatment score - posttreatment score)/ pretreatment score\] × 100%.