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

INTERVENTION: 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 CONDITION: Nocturnal enuresis in children PRIMARY OUTCOME: Frequency of wet episodes per night, per week. This includes waking wet in the night and waking wet in the morning ; The participant diary will record daily Yes or No to the following 2 questions; ; Wakes up wet in the morning ; Wakes through the night wet ; ; ; ; SECONDARY OUTCOME: Adverse reactions and side effects (Number of adverse events and severity of side effects e.g. urinary retention ; Day time continence questions ; (This differs to our primary outcome which is measuring wet episodes at night. These questions will measure if the child was having day time wet episodes and if they subsided or changed during the intervention.). The intervention is completed at Week 8 but the trial is also attempting to establish the level of efficacy of the drug on long term urinary incontinence up to 6 months post the completion of the interventional period. ; ; Does the child urinate in their clothes by accident during the day? Th answer is Yes / No. If Yes then the participant will indicate how many times per week on average 1,2,3,4,5,6,7, more than 7 days. ; Does the child sometimes have a bowel movement in their clothes by accident during the day? The answer is Yes / No, If Yes then the participant will indicate how many times per week on average 1,2,3,4,5,6,7, more than 7 days Has the child had any constipation (greater than 2 days per bowel motion)? ; The answer is Yes / No, If Yes then the participant will indicate how many times per week on average 1,2,3,4,5,6,7, more than 7 days Has the child soiled underwear? ; The answer is Yes / No, If Yes then the participant will indicate how many times per week on average 1,2,3,4,5,6,7, more than 7 days PinQ (child). (Paediatric quality of life questionnaire) ; ; This examines the impact of nocturnal enuresis on the quality of life of the child. PinQ (parental) ; ; Parental perception of the impact of nocturnal enuresis on the quality of life of the child. ; When the child needs to urinate during the day, do they have to go right away? ; The answer is Yes / No, If Yes then the participant will indicate how many times per week on average 1,2,3,4,5,6,7, more than 7 days 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