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临床试验/NCT03733873
NCT03733873已完成不适用

Study on the Therapeutic Schedule and Mechanism of Suoquan Mixture Combined With Desmopressin to Children's Monosymptomatic Enuresis

Children's Hospital of Fudan University1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2018年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
400
试验地点
1
主要终点
the relapse rate of MNE

研究概览

简要总结

Monosymptomatic nocturnal enuresis (MNE) is a common pediatric developmental disorder. MNE refers to urinary incontinence in the sleep state in children aged ≥5 years, without other LUT symptoms, and without bladder dysfunction. Its pathogenesis mainly include overnight polyuria, overactive bladder, sleep-arousal dysfunction, genetics, and abnormal secretion of anti-diuretic hormone (ADH). Desmopressin is a synthetic analog of ADH arginine-vasopressin (AVP), which is used to treat central diabetes insipidus and primary nocturnal enuresis (PNE). Desmopressin decreases urine production at night when taken at bedtime. Insufficient ADH secretion at night will contribute to nocturnal polyuria, which is an important cause of NE. Therefore, desmopressin, a synthetic analog of ADH, is frequently used for NE and is an evidence-based therapy (grade ⅠA evidence). Some children, however, have desmopressin resistance and do not achieve the desired treatment goals. What's more,there's a high relapse rate of desmopressin after withdrawing. Suoquan mixture is a Chinese medicine commonly used to treat NE in children. It is composed of Cuscuta, Codonopsis, Psoralea corylifolia Linn ,Astragalus,mantis egg-case and ephedra. It has not only a certain cure rate but also has a lower relapse rate . However there's few evidence could prove that. In this study,the investigators compared the 3 month treatment response and relapse rate (RR) in the following 6 months of desmopressin and desmopressin plus suoquan, and observe if there will be a lower relapse rare in desmopressin plus Suoquan. Moreover, the investigators will try to explore the mechanism of Suoquan mixture in MNE.

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
Single (Participant)

入排标准

年龄范围
5 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • bedwetting occured ≥2nights/week,last for at least 3 months
  • without other LUT symptoms
  • without bladder dysfunction.
  • no treatment in last 3 months
  • signed the consent

排除标准

  • had other LUT symptoms
  • with bladder dysfunction
  • had treatment in last 3 months
  • without the consent

研究组 & 干预措施

desmopressin plus Suoquan

Experimental

Drug1. name:desmopressin form:tablet dosage:2-4mg frequency:qn duration:3 months Drug2 name:Suoquan mixture form:liquid dosage:10ml/time frequence:bid duration:3 months

干预措施: Desmopressin (Drug)

desmopressin plus Suoquan

Experimental

Drug1. name:desmopressin form:tablet dosage:2-4mg frequency:qn duration:3 months Drug2 name:Suoquan mixture form:liquid dosage:10ml/time frequence:bid duration:3 months

干预措施: Suoquan (Drug)

desmopressin

Active Comparator

name:desmopressin form:tablet dosage:2-4mg frequency:qn duration:3 months

干预措施: Desmopressin (Drug)

结局指标

主要结局

the relapse rate of MNE

时间窗: in 6 months after stopping drugs

If Suoquan mixture plus desmopressin could reduce the relapse rate of MNE

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hong Xu,MD.PhD

chief physician

Children's Hospital of Fudan University

研究点 (1)

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