NCT06853379

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 3, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

March 5, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2025

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2025

Completed
Last Updated

March 3, 2025

Status Verified

February 1, 2025

Enrollment Period

2 months

First QC Date

February 27, 2025

Last Update Submit

February 27, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • number of wet days per week

    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

Study Arms (2)

group A

EXPERIMENTAL

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

Behavioral: dietary recommendationsOther: aroma therapy

Group B

EXPERIMENTAL

GROUP B receive Harpal product

Behavioral: dietary recommendationsOther: aroma therapy

Interventions

. 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

Group Bgroup A

the case receive aroma therapy

Group Bgroup A

Eligibility Criteria

Age5 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • The participants age will be ranged from 5to 10 years.
  • primary Nocturnal enuresis(NE) number of wet nights/week is more than 4\\7

You may not qualify if:

  • secondary nocturnal enuresis to any neurological disorders , musculoskeletal problems, or congenital abnormalities
  • the child receives any Pharmacological treatment to NE

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Nocturnal Enuresis

Interventions

Aromatherapy

Condition Hierarchy (Ancestors)

EnuresisUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesBehavioral SymptomsBehaviorElimination DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPhytotherapySensory Art TherapiesPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

February 27, 2025

First Posted

March 3, 2025

Study Start

March 5, 2025

Primary Completion

May 5, 2025

Study Completion

May 10, 2025

Last Updated

March 3, 2025

Record last verified: 2025-02