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

The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Status and phase: Not yet enrolling; Phase 2

Conditions: Slow Transmission Constipation

Treatments: Drug: prucapride; Other: Auricular Acupoint Stimulation +prucapride

Study type: Interventional

Funder types: Other

Identifiers

NCT06680882

No. 2023AH050848 (Other Grant/Funding Number)

AH2022056

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

study group

Experimental group

Description:

The study group, comprising 30 individuals, received a combination therapy of non-invasive auricular acupoint stimulation and prucapride

Treatment:

Other: Auricular Acupoint Stimulation +prucapride

control group

Other group

Description:

also consisting of 30 patients, was administered prucapride as a monotherapy.

Treatment:

Drug: prucapride