Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12624000796583
Ethics application status
Not required
Date submitted
3/07/2024
Date registered
4/07/2024
Date last updated
4/07/2024
Date data sharing statement initially provided
4/07/2024
Date results information initially provided
4/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
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Scientific title
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Secondary ID [1] 310342 0
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Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
3rd July check for Step 12 bolding 334229 0
Condition category
Condition code
Alternative and Complementary Medicine 330897 330897 0 0
Herbal remedies

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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Intervention code [1] 328919 0
Not applicable
Comparator / control treatment
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Control group
Active

Outcomes
Primary outcome [1] 338653 0
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Timepoint [1] 338653 0
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Secondary outcome [1] 436845 0
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Timepoint [1] 436845 0
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Eligibility
Key inclusion criteria
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Minimum age
12 Years
Maximum age
23 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
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Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/07/2024
Actual
Date of last participant enrolment
Anticipated
27/07/2024
Actual
Date of last data collection
Anticipated
11/08/2024
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT

Funding & Sponsors
Funding source category [1] 314549 0
Government body
Name [1] 314549 0
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Country [1] 314549 0
Australia
Primary sponsor type
Government body
Name
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Address
Country
Australia
Secondary sponsor category [1] 316504 0
None
Name [1] 316504 0
Address [1] 316504 0
Country [1] 316504 0

Ethics approval
Ethics application status
Not required
Ethics committee name [1] 313587 0
Aboriginal Health & Medical Research Council Ethics Committee
Ethics committee address [1] 313587 0
https://www.ahmrc.org.au/ethics-at-ahmrc/
Ethics committee country [1] 313587 0
Australia
Date submitted for ethics approval [1] 313587 0
02/07/2024
Approval date [1] 313587 0
Ethics approval number [1] 313587 0

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

Contacts
Principal investigator
Name 128654 0
Ms 3rd July check for Step 12 bolding
Address 128654 0
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Country 128654 0
Australia
Phone 128654 0
+61 406613421
Fax 128654 0
Email 128654 0
[email protected]
Contact person for public queries
Name 128655 0
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Address 128655 0
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Country 128655 0
Australia
Phone 128655 0
+61 406613421
Fax 128655 0
Email 128655 0
[email protected]
Contact person for scientific queries
Name 128656 0
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Address 128656 0
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Country 128656 0
Australia
Phone 128656 0
+61 406613421
Fax 128656 0
Email 128656 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
no


What supporting documents are/will be available?

Current supporting documents:

Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23955Clinical study reportc1   ok1 386399-(Uploaded-22-05-2024-16-01-49)-387837-(Uploaded-21-05-2024-11-34-15)-ANZCTR IT_Steps 11_12 pre-deployment items to fix_May2024 (3).docx
23956Ethical approvalc2   ok 386399-(Uploaded-22-05-2024-16-02-12)-ANZCTR IT_Steps 11_12 pre-deployment items to fix_May2024 (4).docx
23960Data dictionaryc3   ok3
23961Data dictionaryc4  

Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Supplementary materialsYes ok 387837-(Uploaded-21-05-2024-11-34-15)-ANZCTR IT_Steps 11_12 pre-deployment items to fix_May2024 (3).docx

Documents added automatically
No additional documents have been identified.