Ginko Biloba Versus Desmopressin in Treatment of Children With Monosymptomatic Nocturnal Enuresis

Not Applicable

Completed

• Conditions: Enuresis, Nocturnal
• Interventions: Drug: Ginkgobiloba; Drug: Desmopressin Acetate 0.2 mg Tablets

• Registration Number: NCT06772584
• Lead Sponsor: Menoufia University

Brief Summary

Bedwetting among children is a common disorder, affecting 30% at age 4, 10% at age 6, 3% at age 12, and 1% at age.Untreated, the spontaneous cure rate is about 15% a year. Treatment is dominated by two approaches, enuresis alarm and drugs.

Treatment with drugs has largely been focused on tricyclic antidepressants especially imipramine or, more recently, antidiuretic agents such as desmopressin . For imipramine the proportion of total remission is 10-50% during treatment and a long term cure in 5-40%.8 However, numerous reports of side effects, some lethal, have led to a decline in its use.

Since Dimson in 1977 reported on the effects of desmopressinl" several double blind, placebo controlled studies have shown the efficacy of the drug often with rapid effect but also often with immediate relapse after ending treatment.

While one of theory of nocturnal enuresis is deep sleep in children , this the main cornerstone in using Alarm as line of management .

On the other hand drugs used in rehabitation of sleep rhythm seems to be with great benefits in management as GINKO BILOBA Ginkgo biloba leave extract is among the most widely sold herbal dietary supplements in the United States. Its purported biological effects include: scavenging free radical; lowering oxidative stress; reducing neural damages, reducing platelets aggregation; antiinflammation; anti-tumor activities; anti-aging , and improve night sleep rhythm

Detailed Description

Bedwetting among children is a common disorder, affecting 30% at age 4, 10% at age 6, 3% at age 12, and 1% at age.Untreated, the spontaneous cure rate is about 15% a year. Treatment is dominated by two approaches, enuresis alarm and drugs.

Treatment with drugs has largely been focused on tricyclic antidepressants especially imipramine or, more recently, antidiuretic agents such as desmopressin . For imipramine the proportion of total remission is 10-50% during treatment and a long term cure in 5-40%.8 However, numerous reports of side effects, some lethal, have led to a decline in its use.

Since Dimson in 1977 reported on the effects of desmopressinl" several double blind, placebo controlled studies have shown the efficacy of the drug often with rapid effect but also often with immediate relapse after ending treatment.

While one of theory of nocturnal enuresis is deep sleep in children , this the main cornerstone in using Alarm as line of management .

On the other hand drugs used in rehabitation of sleep rhythm seems to be with great benefits in management as GINKO BILOBA Ginkgo biloba leave extract is among the most widely sold herbal dietary supplements in the United States. Its purported biological effects include: scavenging free radical; lowering oxidative stress; reducing neural damages, reducing platelets aggregation; antiinflammation; anti-tumor activities; anti-aging , and improve night sleep rhythm

Study Timeline

• Study Start: 2024-01-01
• Primary Completion: 2024-07-01
• Study Completion: 2024-12-01
• Status Verified: 2025-01
• Study First Submitted: 2025-01-07
• Study First Submitted QC: 2025-01-10
• Last Update Submitted: 2025-01-10
• Study First Posted: 2025-01-13
• Last Update Posted: 2025-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• All patients with monosymptomatic nocturnal enuresis

Exclusion Criteria

• patients with day and night enuresis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ginkobiloba	Ginkgobiloba	Drug was taken by the pt
Omegapress 0.2	Desmopressin Acetate 0.2 mg Tablets	Omegapress 0.2 was been taken by the pt
Omegapress+ ginkgobiloba	Desmopressin Acetate 0.2 mg Tablets	Both drugs were taken
Omegapress+ ginkgobiloba	Ginkgobiloba	Both drugs were taken

Primary Outcome Measures

Name	Time	Method
To asses the effect of different drugs on number of bed time wetting	3 months	Drugs were administrated to the patient and response was documented regarding to number of bed wetting timed

Trial Locations

Locations (1)

Menofia university; 🇪🇬 Cairo, State Or Province, Egypt