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Trial registered on ANZCTR


Registration number
ACTRN12618000288224
Ethics application status
Approved
Date submitted
12/12/2017
Date registered
23/02/2018
Date last updated
8/02/2022
Date data sharing statement initially provided
25/09/2019
Date results provided
8/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase 2 placebo controlled, double-blind randomised clinical trial assessing the efficacy of a Herbal supplement for Nocturnal Enuresis in Children
Scientific title
A Phase 2 placebo controlled, double-blind randomised clinical trial assessing the efficacy of a Herbal supplement for Nocturnal Enuresis in Children
Secondary ID [1] 293594 0
Nil
Universal Trial Number (UTN)
Nil known
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nocturnal enuresis in children 305848 0
Condition category
Condition code
Renal and Urogenital 305058 305058 0 0
Other renal and urogenital disorders
Alternative and Complementary Medicine 305414 305414 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 300127 0
Treatment: Drugs
Comparator / control treatment
Identical vegetarian capsule containing colour-matched cellulose to that of the active treatment
Control group
Placebo

Outcomes
Primary outcome [1] 304219 0
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
Timepoint [1] 304219 0
Weekly for the 8 weeks while the participants are taking the intervention.

The diary will be used for 32 weeks (8 weeks of intervention, and 6 months post intervention)
Secondary outcome [1] 341278 0
PinQ (child). (Paediatric quality of life questionnaire)

This examines the impact of nocturnal enuresis on the quality of life of the child.
Timepoint [1] 341278 0
Baseline, Week 4, Week 8, Week 32(over phone)
Secondary outcome [2] 341279 0
PinQ (parental)

Parental perception of the impact of nocturnal enuresis on the quality of life of the child.
Timepoint [2] 341279 0
Baseline, Week 4, Week 8, Week 32(over phone)
Secondary outcome [3] 341294 0
Adverse reactions and side effects (Number of adverse events and severity of side effects e.g. urinary retention
Timepoint [3] 341294 0
At all clinic visits (Week 4 and Week 8), and Phone follow up calls at Week 16, 24, 32
Plus any other noted adverse event or reaction outside of these time points while the participant is on the trial
Secondary outcome [4] 342361 0
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.
Timepoint [4] 342361 0
Week 0 (baseline), Week 4, Week 8, Week 16, Week 24, Week 32

This data is collected via questions at Week 0,4,8 clinic visits, and Week 16, 24 and 32 over the phone.
Secondary outcome [5] 342851 0
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
Timepoint [5] 342851 0
Week 0 (baseline), Week 4, Week 8, Week 16, Week 24, Week 32

This data is collected via questions at Week 0,4,8 clinic visits, and Week 16, 24 and 32 over the phone.
Secondary outcome [6] 342852 0
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
Timepoint [6] 342852 0
Week 0 (baseline), Week 4, Week 8, Week 16, Week 24, Week 32

This data is collected via questions at Week 0,4,8 clinic visits, and Week 16, 24 and 32 over the phone.
Secondary outcome [7] 342853 0
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
Timepoint [7] 342853 0
Week 0 (baseline), Week 4, Week 8, Week 16, Week 24, Week 32

This data is collected via questions at Week 0,4,8 clinic visits, and Week 16, 24 and 32 over the phone.
Secondary outcome [8] 342854 0
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
Timepoint [8] 342854 0
Week 0 (baseline), Week 4, Week 8, Week 16, Week 24, Week 32

This data is collected via questions at Week 0,4,8 clinic visits, and Week 16, 24 and 32 over the phone.

Eligibility
Key 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
Minimum age
6 Years
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis
Initial determination was that 80 participants were required (20% attrition rate) after a sample size calculation was conducted. The calculation was conducted on a trial assessing desmopressin and oxybutynin for nocturnal enuresis.. The trial recruited 66 children who underwent treatment for 3 months. The website used for sample size was: http://clincalc.com/stats/samplesize.aspx .

After interim analysis as requested by the ethics committee, a power sample size calculation was conducted and concluded that 62 participants are required with 31 participants in each arm. Due to saturation in Brisbane, the trial will continue in Sydney Australia.

All data will be analyzed on STATA ©14. Analyses will be conducted on an intention to treat basis. Descriptive statistics will be calculated. The difference in change between groups will be tested using paired T tests, test of proportions and Analysis of Variance (ANOVA), Groups will be compared at baseline and if difference(s) is/are ascertained, the variable(s) will be entered into the regression model to appropriately adjust the analyses.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/03/2018
Actual
25/04/2018
Date of last participant enrolment
Anticipated
30/06/2020
Actual
30/09/2020
Date of last data collection
Anticipated
30/11/2020
Actual
15/10/2021
Sample size
Target
62
Accrual to date
Final
42
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment postcode(s) [1] 18294 0
4006 - Fortitude Valley
Recruitment postcode(s) [2] 28131 0
2000 - Haymarket

Funding & Sponsors
Funding source category [1] 298211 0
Government body
Name [1] 298211 0
Federal Grant- Innovations Connections project
Country [1] 298211 0
Australia
Funding source category [2] 298212 0
Commercial sector/Industry
Name [2] 298212 0
Seipel Group
Country [2] 298212 0
Australia
Primary sponsor type
Other
Name
Endeavour College of Natural Health
Address
Office of Research
Level 2, 269 Wickham Street
Fortitude Valley, 4006,
Queensland, Australia
Country
Australia
Secondary sponsor category [1] 297315 0
None
Name [1] 297315 0
Address [1] 297315 0
Country [1] 297315 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299219 0
University of Technology, Sydney
Ethics committee address [1] 299219 0
Ethics committee country [1] 299219 0
Australia
Date submitted for ethics approval [1] 299219 0
17/11/2017
Approval date [1] 299219 0
15/02/2018
Ethics approval number [1] 299219 0
ETH17-1926
Ethics committee name [2] 299220 0
Endeavour College of Natural Health
Ethics committee address [2] 299220 0
Ethics committee country [2] 299220 0
Australia
Date submitted for ethics approval [2] 299220 0
15/02/2018
Approval date [2] 299220 0
Ethics approval number [2] 299220 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79698 0
Dr Janet Schloss
Address 79698 0
Endeavour College of Natural Health
Office of Research, Level 2
269 Wickham Street,
Fortitude Valley, 4006
Queensland, Australia
Country 79698 0
Australia
Phone 79698 0
+61 7 3253 9579
Fax 79698 0
Email 79698 0
janet.schloss@endeavour.edu.au
Contact person for public queries
Name 79699 0
Helen Heathwood
Address 79699 0
Endeavour College of Natural Health
Office of Research, Level 2
269 Wickham Street,
Fortitude Valley, 4006
Queensland, Australia
Country 79699 0
Australia
Phone 79699 0
+61 466941057
Fax 79699 0
Email 79699 0
trials@endeavour.edu.au
Contact person for scientific queries
Name 79700 0
Janet Schloss
Address 79700 0
Endeavour College of Natural Health
Office of Research, Level 2
269 Wickham Street,
Fortitude Valley, 4006
Queensland, Australia
Country 79700 0
Australia
Phone 79700 0
+61 7 3253 9579
Fax 79700 0
Email 79700 0
janet.schloss@endeavour.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
All data is de-identified coded and analysed in a summary form


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA randomised, double-blind, placebo-controlled clinical trial assessing the efficacy of bedtime buddy for the treatment of nocturnal enuresis in children.2019https://dx.doi.org/10.1186/s12887-019-1797-8
EmbaseA randomised, double-blind, placebo-controlled clinical trial found that a novel herbal formula Urox (Bedtime Buddy) assisted children for the treatment of nocturnal enuresis.2021https://dx.doi.org/10.1016/j.phymed.2021.153783
N.B. These documents automatically identified may not have been verified by the study sponsor.