Auricular Acupoint Stimulation +prucapride
OtherThe study group, comprising 30 individuals, received a combination therapy of non-invasive auricular acupoint stimulation and prucapride
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NCT Number: NCT06680882
The Effect of Non-invasive Auricular Acupoint Stimulation on Slow Transmission Constipation
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.
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Trial opening soon.
Get NotifiedKey information
Conditions
Age range
40 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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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Treatment and study plan
prucapride
Drugwas administered prucapride as a monotherapy
Primary outcomes
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overall efficacy rate
Time frame: 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%.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Other
Registry information
Official study title
The Second Hospital Affiliated Anhui University of Chinese Medicine
Acronym: AAS
Important dates
- Study start
- 2024
- Primary completion
- 2024
- Study completion
- 2025
- First posted
- Nov 8, 2024
- Registry last updated
- Nov 8, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.