- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06853379
Aromatherapy Versus Diet
February 27, 2025 updated by: Ahmed fekry ibrahim salman, Cairo University
Aromatherapy Versus Diet Management on Children with Primary Nocturnal Enuresis
Eligible children were randomly divided into 2 groups assigned to receive dietary recommendations (group A) or to receive herbal compounds (group B).
Children were treated for a period of one week , then cross over the two groups is done
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- The participants age will be ranged from 5to 10 years.
- primary Nocturnal enuresis(NE) number of wet nights/week is more than 4\7
Exclusion Criteria:
- secondary nocturnal enuresis to any neurological disorders , musculoskeletal problems, or congenital abnormalities
- the child receives any Pharmacological treatment to NE
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: group A
Children were receive dietary recommendations or nonspecific dietary advices such as reducing fluid intake after 6 p.m.
The list of dietary advices have been made reviewing literature and consisted in a list of recommended food, not recommended food at evening and not recommended food
|
. receive dietary recommendations or nonspecific dietary advices such as reducing fluid intake after 6 p.m.
The list of dietary advices have been made reviewing literature and consisted in a list of recommended food, not recommended food at evening and not recommended food
the case receive aroma therapy
|
|
Experimental: Group B
GROUP B receive Harpal product
|
. receive dietary recommendations or nonspecific dietary advices such as reducing fluid intake after 6 p.m.
The list of dietary advices have been made reviewing literature and consisted in a list of recommended food, not recommended food at evening and not recommended food
the case receive aroma therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
number of wet days per week
Time Frame: ; for baseline evaluation of number of wet days per week, if the number is less than 4\7 the child will be excluded from the study. Second week; group A receives dietary recommendations , group B receives herbal compounds
|
for baseline evaluation of number of wet days per week, if the number is less than 4\7 the child will be excluded from the study.
|
; for baseline evaluation of number of wet days per week, if the number is less than 4\7 the child will be excluded from the study. Second week; group A receives dietary recommendations , group B receives herbal compounds
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
March 5, 2025
Primary Completion (Estimated)
May 5, 2025
Study Completion (Estimated)
May 10, 2025
Study Registration Dates
First Submitted
February 27, 2025
First Submitted That Met QC Criteria
February 27, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 27, 2025
Last Verified
February 1, 2025
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
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Behavioral Symptoms
- Elimination Disorders
- Urinary Incontinence
- Enuresis
- Nocturnal Enuresis
Other Study ID Numbers
- aromatherapy versus diet
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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.
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