- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06771128
Ginkgo Biloba vs Desmopressin in Treatment of Children With Monosymptomatic Nocturnal Enuresis
Ginkgo Biloba Versus Desmopressin in Treatment of Children With Monosymptomatic Nocturnal Enuresis: A Randomized Prospective Study
Study Overview
Status
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%. However, numerous reports of side effects, some lethal, have led to a decline in its use.
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 re-habitation of sleep rhythm seems to be with great benefits in management as GINKGO 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; anti-inflammation; anti-tumor activities; anti-aging, and improve night sleep rhythm.
the aim of this study is to evaluate the effect of Ginkgo Biloba versus desmopressin in treatment of children with monosymptomatic nocturnal enuresis.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Menoufia
-
Shebin El-Kom, Menoufia, Egypt, 32511
- Menoufia Faculty of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- all children with monosymptomatic nocturnal enuresis.
Exclusion Criteria:
- children with day and night wetting.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Ginkgo Biloba group
Patients in this group receive Ginkgo Biloba oral tablet.
|
patients receive Ginkgo Biloba oral tablet 120 mg once daily
patients receive Desmopressin like Placebo oral tablet once daily
|
|
Active Comparator: Desmopressin group
Patients in this group receive Desmopressin oral tablets.
|
patient receives desmopressin 0.2 mg oral tablet once daily
patients receive Ginkgo Biloba like Placebo oral tablet once daily
|
|
Experimental: Combination group
Patients in this group receive both Ginkgo Biloba and desmopressin oral tablets.
|
patients receive Ginkgo Biloba oral tablet 120 mg once daily
patient receives desmopressin 0.2 mg oral tablet once daily
|
|
Placebo Comparator: Placebo group
Patients in this group receive Placebo oral tablet.
|
patients receive Desmopressin like Placebo oral tablet once daily
patients receive Ginkgo Biloba like Placebo oral tablet once daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Night wetting frequency
Time Frame: 1, 3 months
|
Night wetting frequency is measured by the number of wet nights per week.
|
1, 3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Mental Disorders
- Male Urogenital Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urination Disorders
- Behavioral Symptoms
- Elimination Disorders
- Behavior
- Enuresis
- Nocturnal Enuresis
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Peptide Hormones
- Neuropeptides
- Peptides
- Amino Acids, Peptides, and Proteins
- Oligopeptides
- Nerve Tissue Proteins
- Proteins
- Plant Extracts
- Plant Preparations
- Biological Products
- Complex Mixtures
- Pituitary Hormones, Posterior
- Pituitary Hormones
- Arginine Vasopressin
- Vasopressins
- Deamino Arginine Vasopressin
- Ginkgo Extract
Other Study ID Numbers
- Ginkgo Biloba vs Desmopressin
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Monosymptomatic Nocturnal Enuresis
-
Menoufia UniversityActive, not recruitingTreatment of Non-monosymptomatic Nocturnal EnuresisEgypt
-
University GhentCompletedMonosymptomatic Nocturnal EnuresisBelgium
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