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

NCT06680882 | Not Yet Recruiting Phase 2 DMC

• 2 other identifiers: AH2022056No. 2023AH050848
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Slow Transmission Constipation

Keywords

slow transmission constipation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

study group

EXPERIMENTAL

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

Other: Auricular Acupoint Stimulation +prucapride

control group

OTHER

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

Drug: prucapride

Interventions

Auricular Acupoint Stimulation +prucapride OTHER

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

study group

prucapride DRUG

was administered prucapride as a monotherapy

control group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

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

Central Study Contacts

Heng Deng, Dr.

CONTACT

+8613335510159; tangkun23@outlook.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The Second hospital affiliated Anhui University of Chinese Medicine

Model Details: slow transmission constipation

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 8, 2024
• Study Start: November 7, 2024
• Primary Completion: November 7, 2024
• Study Completion: November 1, 2025
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share