A Phase 2 placebo controlled, double-blind randomised clinical trial assessing the efficacy of a Herbal supplement for Nocturnal Enuresis in Children

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12618000288224

Enrollment

Registered

2018-02-23

Start date

2018-04-25

Completion date

2020-09-30

Last updated

2022-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of the study is to determine the effectiveness of a herbal combination capsule (Urox - Bedtime Buddy™), in the treating children aged 6-14 years who experience bed-wetting. It is hypothesised that the combination capsule will reduce the frequency of bed- wetting in children and therefore improve the physical, psycho social and social well being of the child. The trial aims to recruit 62 children in a randomised control trial where the child will receive either the active herbal combination capsule or a placebo. They will take the capsule daily for 8 weeks and record frequency of wet nights in a diary. The parent and child will also complete a validated questionnaire on the impact of bed-wetting on the child quality of life at various time-points in the trial. After the trial is completed follow up phone calls will measure frequency of nocturnal enuresis as well as day time continence questions at 16, 24 and 32 weeks.

Interventions

Herbal capsule formulation consisting of; Crateva (Crataeva nurvala) 3000mg Horsetail (Equisetum arvense) 1500mg Lindera (Lindera strychnifolia) 1500mg 1 capsule in the morning (equal to or less than 40kg) or 2 capsules in the morning (greater than 40kg) Duration:8 weeks Monitoring: Participant diary, drug tablet return

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

6 Years to 14 Years

Healthy volunteers

Inclusion criteria

• Any gender • Has bed wetting issues equal to or greater than 3 times per week (wet nights) • Aged: equal to or greater than 6 years old to equal to or less than 14 years old

Exclusion criteria

• Vesicoureteral reflux • Spinal dysraphism • Recent urotherapy • Recent or current urinary tract infection (< 1 week) • Active cancer currently on treatment • History of cardiac failure • History of renal dysfunction or urinary retention

Outcome results