An interventional study of Sulbutiamine and Imipramine in Nocturnal Enuresis in Children, sponsored by Sohag University. Status unknown at 1 site in Egypt. Open to participants aged 6 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-12.
Sponsored by Sohag University · Not applicable, Interventional, and Treatment
The aim of the study is to evaluate the role of sulbutiamine in treatment of monosymptomatic nocturnal enuresis in children by using it alone or as a combination therapy with tricyclic antidepressants (imipramine+sulbutiamine).
Sohag University is the lead sponsor of 1,218 studies on the registry; 627 are open to participants now.
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Exclusion Criteria:
this group will receive imipramine alone
Drug: Imipramine
this group will receive sulbutiamine alone
Drug: Sulbutiamine
this group will receive sulbutiamine plus imipramine
Drug: Sulbutiamine · Drug: Imipramine
sulbutiamine will be used by oral route 100 mg daily for 1 month and follow up will be done every 1 month till 3 months. it will be used alone in group B and combined with imipramine in group C
imipramine will be used by oral route 25 mg daily for 1 month and follow up will be done every 1 month till 3 months. it will be used alone in group A and combined with sulbutiamine in group C
reduction in the number of wet nights .
A questionnaire which measure the Response to treatment which will be evaluated by the standardization committee of International clildren's continence society (ICCS) as follows : * Complete response : 100% reduction * Partial response : 50% - 99% reduction * Unresponsiveness : 0 - 49% reduction in nocturnal enuresis episodes. this will be measured by a questionnaire that will be written according a calendar fulfilled by the child and his parents with comparison of the number of wet nights each month.
Time frame: the number of wet nights will be measured and compared at the end of each month for 3 months using a calendar fulfilled by the child and his parents.
determine any side effects of the drugs used in the study
asking the child and his parents about any abnormal findings or symptoms appear in the period of the treatment this will be done by a questionnaire that will be fulfilled by the child and his parents.
Time frame: this will be discussed in the follow up that will be done in each month in the outpatient clinic for 3 months.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Imipramine