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Study on Chinese and Western Medicine in MNE Children

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Durumİşe alma
Sponsorlar
Children's Hospital of Fudan University

Anahtar kelimeler

Öz

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.

Tarih

Son Doğrulandı: 10/31/2019
İlk Gönderilen: 11/05/2018
Tahmini Kayıt Gönderildi: 11/05/2018
İlk Gönderilen: 11/06/2018
Son Güncelleme Gönderildi: 11/07/2019
Son Güncelleme Gönderildi: 11/11/2019
Fiili Çalışma Başlangıç Tarihi: 02/13/2019
Tahmini Birincil Tamamlanma Tarihi: 10/31/2020
Tahmini Çalışma Tamamlanma Tarihi: 11/30/2020

Durum veya hastalık

Monosymptomatic Nocturnal Enuresis

Müdahale / tedavi

Drug: Desmopressin

Drug: desmopressin plus Suoquan

Evre

-

Kol Grupları

KolMüdahale / tedavi
Experimental: desmopressin plus Suoquan
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
Drug: desmopressin plus Suoquan
take Suoquan mixture for 3 months
Active Comparator: desmopressin
name:desmopressin form:tablet dosage:2-4mg frequency:qn duration:3 months

Uygunluk kriterleri

Çalışmaya Uygun Yaşlar 5 Years İçin 5 Years
Çalışmaya Uygun CinsiyetlerAll
Sağlıklı Gönüllüleri Kabul EdiyorEvet
Kriterler

Inclusion Criteria:

- 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

Exclusion Criteria:

- had other LUT symptoms

- with bladder dysfunction

- had treatment in last 3 months

- without the consent

Sonuç

Birincil Sonuç Ölçütleri

1. the relapse rate of MNE [in 6 months after stopping drugs]

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

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