Health Condition 1: null- Nocturnal enuresis
Conditions
Interventions
Intervention1: Hops flower extract(Humulus lupulas aromatherapy: aromatherapy liquid will be instructed to take as 13 drops per day on one clean handkerchief or cotton at night(bedtime). Route of admi
Sponsors
Inzepera Healthsciences Ltd
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 2. Change in nocturnal enuresis grading from baseline to end of treatment. Timepoint: total seven Visits 15 ±2 days interval From Visit 1 (Day 0) to Visit 7 (90±2) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Subjective global assessment of patient status regarding their incontinence on visual analogue scale before and after the treatment 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 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) | — |
Countries
India
Contacts
Public ContactDr Vikas S Shevante
AnaZeal Analyticals and Research Pvt.Ltd.
Outcome results
None listed