Study on Chinese and Western Medicine in MNE Children
Primary Purpose
Monosymptomatic Nocturnal Enuresis
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Desmopressin
Suoquan
Sponsored by
About this trial
This is an interventional treatment trial for Monosymptomatic Nocturnal Enuresis focused on measuring nocturnal enuresischildren, Chinsese medicine, children, relapse rate
Eligibility Criteria
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
Sites / Locations
- Children's hospital of Fudan university
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
desmopressin plus Suoquan
desmopressin
Arm Description
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
name:desmopressin form:tablet dosage:2-4mg frequency:qn duration:3 months
Outcomes
Primary Outcome Measures
the relapse rate of MNE
If Suoquan mixture plus desmopressin could reduce the relapse rate of MNE
Secondary Outcome Measures
Full Information
NCT ID
NCT03733873
First Posted
November 6, 2018
Last Updated
March 9, 2021
Sponsor
Children's Hospital of Fudan University
1. Study Identification
Unique Protocol Identification Number
NCT03733873
Brief Title
Study on Chinese and Western Medicine in MNE Children
Official Title
Study on the Therapeutic Schedule and Mechanism of Suoquan Mixture Combined With Desmopressin to Children's Monosymptomatic Enuresis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
January 30, 2020 (Actual)
Study Completion Date
July 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital of Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Monosymptomatic Nocturnal Enuresis
Keywords
nocturnal enuresischildren, Chinsese medicine, children, relapse rate
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
group1 desmopressin group2 desmopressin plus Suoquan mixture
Masking
Participant
Allocation
Randomized
Enrollment
400 (Actual)
8. Arms, Groups, and Interventions
Arm Title
desmopressin plus Suoquan
Arm Type
Experimental
Arm Description
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
Arm Title
desmopressin
Arm Type
Active Comparator
Arm Description
name:desmopressin form:tablet dosage:2-4mg frequency:qn duration:3 months
Intervention Type
Drug
Intervention Name(s)
Desmopressin
Other Intervention Name(s)
Minirin
Intervention Description
take desmopressin for 3 months
Intervention Type
Drug
Intervention Name(s)
Suoquan
Other Intervention Name(s)
Suoquan mixture
Intervention Description
take Suoquan mixture for 3 months
Primary Outcome Measure Information:
Title
the relapse rate of MNE
Description
If Suoquan mixture plus desmopressin could reduce the relapse rate of MNE
Time Frame
in 6 months after stopping drugs
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hong Xu, MD.PhD.
Organizational Affiliation
Children's Hospital of Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's hospital of Fudan university
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study on Chinese and Western Medicine in MNE Children
We'll reach out to this number within 24 hrs