Aromatherapy for children from 5 to 10 years old having bed wetting problems

Not Applicable

Completed

• Conditions: Health Condition 1: null- Nocturnal enuresis

• Registration Number: CTRI/2017/06/008911
• Lead Sponsor: Inzepera Healthsciences Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-06-08
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

1.Children between the age group 5-10 years.

2.Children suffering from enuresis grade 1 and grade 2.

3.Parents or legal guardians who will sign written informed consent form for the child.

4.Children and parents / Guardians who agree to comply with study requirement and schedule.

Exclusion Criteria

1.Children suffering from enuresis grade 2, with associated disorders such as diabetes, urinary tract infections, urogenital malformations, inability to recognize a full bladder, chronic constipation and diagnosed resistant to bedwetting treatments.

2.Children suffering from attention-deficit hyperactivity disorder, conditions associated with large urine volumes, abnormal neurological control, abnormalities of bladder and urinary tracts.

3.Inability to keep return appointments.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Change in degree of incontinence as their life quality relationship before and after treatment will be assessed in a monthly calendar (PDDC) with dayâ??s bedwetting episodes before, during and after treatment. <br/ ><br>2. Change in nocturnal enuresis grading from baseline to end of treatment. <br/ ><br>Timepoint: total seven Visits 15 ±2 days interval From Visit 1 (Day 0) to Visit 7 (90±2)

Secondary Outcome Measures

Name	Time	Method
1. Subjective global assessment of patient status regarding their incontinence on visual analogue scale before and after the treatment <br/ ><br>2. Change in nocturnal enuresis will be assessed from patientâ??s diary card- compared between Baseline values â?? after the removal of aromatherapy values and end of treatment values <br/ ><br>3. Assessment of adverse events occurred, if any and trial medication consumption, during treatment period.Timepoint: Total seven Visits 15 ±2 days interval From Visit 1 (Day 0) to Visit 7 (90±2)