A Phase 2 interventional study of Auricular Acupoint Stimulation +prucapride and prucapride in Slow Transmission Constipation, sponsored by The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine. Not yet recruiting. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-11-08.
Sponsored by The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine · Phase 2, Interventional, and Treatment
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.
1,046 studies on the registry are indexed under Constipation; 161 are open to participants now.
This study's planned enrollment of 60 is below the median of 75 across 884 interventional studies indexed under Constipation.
Browse Constipation studies →The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine is the lead sponsor of 7 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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 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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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study group, comprising 30 individuals, received a combination therapy of non-invasive auricular acupoint stimulation and prucapride
Other: Auricular Acupoint Stimulation +prucapride
also consisting of 30 patients, was administered prucapride as a monotherapy.
Drug: prucapride
The study group, comprising 30 individuals, received a combination therapy of non-invasive auricular acupoint stimulation and prucapride
was administered prucapride as a monotherapy
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%.
Time frame: From enrollment to the end of treatment at one week
No study locations are listed for this record.
Plan to share: Yes — all IPD collected throughout the trial, only IPD used in the results publication
No publications or documents are linked to this record.
Start is estimated for Nov 2024.
Of 41 phase 2 interventional studies under Constipation, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 42. This study's planned 0 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine