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

The Second Hospital Affiliated Anhui University of Chinese Medicine

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Slow Transmission Constipation
• Intervention / Treatment: Other: Auricular Acupoint Stimulation +prucapride; Drug: prucapride

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Heng Deng, Dr.; Phone Number: +8613335510159; Email: tangkun23@outlook.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

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

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: study group; The study group, comprising 30 individuals, received a combination therapy of non-invasive auricular acupoint stimulation and prucapride	Other: Auricular Acupoint Stimulation +prucapride; The study group, comprising 30 individuals, received a combination therapy of non-invasive auricular acupoint stimulation and prucapride
Other: control group; also consisting of 30 patients, was administered prucapride as a monotherapy.	Drug: prucapride; was administered prucapride as a monotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall efficacy rate	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%.	From enrollment to the end of treatment at one week

Collaborators and Investigators

• Sponsor: The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): November 7, 2024
• Primary Completion (Actual): November 7, 2024
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: November 6, 2024
• First Submitted That Met QC Criteria: November 6, 2024
• First Posted (Estimated): November 8, 2024

Study Record Updates

• Last Update Posted (Estimated): November 8, 2024
• Last Update Submitted That Met QC Criteria: November 6, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: slow transmission constipation
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: AH2022056; No. 2023AH050848 (Other Grant/Funding Number: Scientific Research Project of Colleges and Universities of Anhui Province)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all IPD collected throughout the trial, only IPD used in the results publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No