The Second Hospital Affiliated Anhui University of Chinese Medicine
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- overall efficacy rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •① Withdrawal from the therapeutic regimen; ② Auricle or ear canal pathologies; ③ Organic defecation disorder; ④ Pregnant or lactating.
研究组 & 干预措施
study group
The study group, comprising 30 individuals, received a combination therapy of non-invasive auricular acupoint stimulation and prucapride
干预措施: Auricular Acupoint Stimulation +prucapride (Other)
control group
also consisting of 30 patients, was administered prucapride as a monotherapy.
干预措施: prucapride (Drug)
结局指标
主要结局
overall efficacy rate
时间窗: 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%.
次要结局
未报告次要终点
研究者
Heng Deng
The Second hospital affiliated Anhui University of Chinese Medicine
The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine