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
ACTRN12624000792527
Ethics application status
Not required
Date submitted
27/06/2024
Date registered
27/06/2024
Date last updated
27/06/2024
Date data sharing statement initially provided
27/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
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Scientific title
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Secondary ID [1] 312413 0
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Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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Condition category
Condition code
Alternative and Complementary Medicine 330894 330894 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] 328916 0
Not applicable
Comparator / control treatment
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Control group
Active

Outcomes
Primary outcome [1] 338650 0
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Timepoint [1] 338650 0
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Secondary outcome [1] 436842 0
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Timepoint [1] 436842 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
6/07/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT

Funding & Sponsors
Funding source category [1] 316824 0
Government body
Name [1] 316824 0
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Country [1] 316824 0
Australia
Primary sponsor type
Government body
Name
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Address
Country
Australia
Secondary sponsor category [1] 319054 0
None
Name [1] 319054 0
Address [1] 319054 0
Country [1] 319054 0

Ethics approval
Ethics application status
Not required
Ethics committee name [1] 315594 0
Aboriginal Health & Medical Research Council Ethics Committee
Ethics committee address [1] 315594 0
https://www.ahmrc.org.au/ethics-at-ahmrc/
Ethics committee country [1] 315594 0
Australia
Date submitted for ethics approval [1] 315594 0
13/06/2024
Approval date [1] 315594 0
Ethics approval number [1] 315594 0

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

Contacts
Principal investigator
Name 135182 0
Ms Check for duplicates in Step 11
Address 135182 0
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Country 135182 0
Australia
Phone 135182 0
+61 406613421
Fax 135182 0
Email 135182 0
[email protected]
Contact person for public queries
Name 135183 0
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Address 135183 0
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Country 135183 0
Australia
Phone 135183 0
+61 406613421
Fax 135183 0
Email 135183 0
[email protected]
Contact person for scientific queries
Name 135184 0
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Address 135184 0
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Country 135184 0
Australia
Phone 135184 0
+61 406613421
Fax 135184 0
Email 135184 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
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What supporting documents are/will be available?

Current supporting documents:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23920Analytic codec1 new update   ok1
23940Data dictionaryc3 final [email protected] ok3 yeepyyyy
23941Ethical approvalc4 updated it   ok4 final yeppyy
23942Statistical analysis planc5  


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23920Analytic codec1 new update   ok1
23940Data dictionaryc3 final (Now TESTING) [email protected] ok3 yeepyyyy
23941Ethical approvalc4 updated it   ok4 final yeppyy
23942Statistical analysis planc5  
New Record*Ethical approvalc7  
New Record*[Marked for deletion] Data dictionaryc6  

Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.