Ignite Creation Date:
2024-05-06 @ 12:21 PM
Last Modification Date:
2024-10-26 @ 12:57 PM
Study NCT ID:
NCT03733873
Status:
COMPLETED
Last Update Posted:
2021-03-11
First Post:
2018-11-06
Brief Title:
Study on Chinese and Western Medicine in MNE Children
Sponsor:
Childrens Hospital of Fudan University
Organization:
Childrens Hospital of Fudan University
Study Overview
Official Title:
Study on the Therapeutic Schedule and Mechanism of Suoquan Mixture Combined With Desmopressin to Childrens Monosymptomatic Enuresis
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 Whats moretheres 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 Astragalusmantis egg-case and ephedra It has not only a certain cure rate but also has a lower relapse rate However theres few evidence could prove that In this studythe 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None