Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000010493
Ethics application status
Approved
Date submitted
7/10/2015
Date registered
12/01/2016
Date last updated
13/12/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A naturalistic, observational study of Western herbal medicine practice in self-reported
anxiety and depression
Scientific title
A naturalistic, observational study of Western herbal medicine practice in self-reported
anxiety and depression
Secondary ID [1] 287626 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 296438 0
Anxiety 296439 0
Condition category
Condition code
Alternative and Complementary Medicine 296702 296702 0 0
Herbal remedies
Mental Health 296703 296703 0 0
Anxiety
Mental Health 296704 296704 0 0
Depression

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
An observational study of the outcome of individualised herbal medicine (as prescribed by a naturopath qualified in herbal medicine) over 16 weeks on depression and anxiety (i.e. this study will be observing and documenting the effects of individualised herbalism rather than individual herbal therapies - herbal medicines will be prescribed according to patient presentation in ingestible tablet, tincture or tea form drawn from common practitioner-only range of products in naturopathic dispenseries). Please note this is not an interventional study. We are documenting treatment as it occurs in natural practice, at the discretion of the practitioner (note: these will be included as variables). This is a hypothesis generating study, with some effectiveness measures, but these will be used to identify priorities for further investigation in an interventional, comparative study.

Participants will be receiving an individualised herbal medicine intervention irrespective of their enrolment in this study (under the care of the same practitioner). Treatment is also identical to the treatment that the participant would have received had they not been enrolled in the study, i.e. there is no change to care as a result of enrolment. This includes the duration of treatment which would have been prescribed.
Intervention code [1] 293028 0
Not applicable
Comparator / control treatment
Naturalistic observational study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296312 0
Profile of Mood States form (POMS)
Timepoint [1] 296312 0
Baseline, 1st follow-up and 2nd follow-up.

Note: As this is an observational hypothesis generating study, rather than an interventional study, we are monitoring treatment for three sessions. The follow-up session timepoints remain at the discretion of the practitioner, as we are observing naturalistic practice.
Primary outcome [2] 296313 0
Depression and Anxiety Stress Scale (DASS)
Timepoint [2] 296313 0
Baseline, 1st follow-up and 2nd follow-up.

Note: As this is an observational hypothesis generating study, rather than an interventional study, we are monitoring treatment for three sessions. The follow-up session timepoints remain at the discretion of the practitioner, as we are observing naturalistic practice.
Secondary outcome [1] 318142 0
Short Form 26 Quality of Life Scale
Timepoint [1] 318142 0
Baseline, 1st follow-up and 2nd follow-up.

Note: As this is an observational hypothesis generating study, rather than an interventional study, we are monitoring treatment for three sessions. The follow-up session timepoints remain at the discretion of the practitioner, as we are observing naturalistic practice.
Secondary outcome [2] 318143 0
Participants qualitative experience (via purpose-designed, semi-structured questions) will be measured via a free-text questionnaire
Timepoint [2] 318143 0
Baseline, 1st follow-up, 2nd follow-up.

Note: As this is an observational hypothesis generating study, rather than an interventional study, we are monitoring treatment for three sessions. The follow-up session timepoints remain at the discretion of the practitioner, as we are observing naturalistic practice.

Eligibility
Key inclusion criteria
Patient inclusion criteria consists of any adults (aged 18-70)
presenting with either self-reported depressed mood and/or anxiety (ongoing for more than two weeks) as their primary complaint and reason for seeking treatment (although they may have other co-morbid health issues as well). Participants will already be already due to receive individualised herbal medicine as their treatment regardless of their participation in this study.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Outside the age range
2) Not competent in English reading, writing, and speaking

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2016
Actual
1/03/2016
Date of last participant enrolment
Anticipated
1/07/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 292186 0
University
Name [1] 292186 0
Endeavour College of Natural Health
Country [1] 292186 0
Australia
Primary sponsor type
University
Name
University of Technology Sydney
Address
15 Broadway, Ultimo, NSW 2007
Country
Australia
Secondary sponsor category [1] 290864 0
None
Name [1] 290864 0
Address [1] 290864 0
Country [1] 290864 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293659 0
University of Technology Human Research Ethics Committee
Ethics committee address [1] 293659 0
15 Broadway, Ultimo NSW 2007
Ethics committee country [1] 293659 0
Australia
Date submitted for ethics approval [1] 293659 0
Approval date [1] 293659 0
11/06/2015
Ethics approval number [1] 293659 0
2014000809

Summary
Brief summary
The project is a naturalistic observational study of individualised Western herbal medicine in a naturopathic practice setting. This project will explore the effectiveness of individualised herbal medicine prescriptions in self-reported anxiety and depressions, using a whole practice framework. This approach will not only help to evaluate total herbal medicine practice as it is practised – rather than evaluate individual herbal medicines in specific conditions in a manner which does not reflect practice – but will also help to develop research capacity on the herbal practitioner community, who will be involved in the study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60862 0
Dr Jon Wardle
Address 60862 0
Faculty of Health, University of Technology, 235-253 Jones St, Ultimo NSW 2007
Country 60862 0
Australia
Phone 60862 0
+61 2 9514 4813
Fax 60862 0
+61 2 9514 4835
Email 60862 0
[email protected]
Contact person for public queries
Name 60863 0
Dr Jon Wardle
Address 60863 0
Faculty of Health, University of Technology, 235-253 Jones St, Ultimo NSW 2007
Country 60863 0
Australia
Phone 60863 0
+61 2 9514 4813
Fax 60863 0
+61 2 9514 4835
Email 60863 0
[email protected]
Contact person for scientific queries
Name 60864 0
Dr Jon Wardle
Address 60864 0
Faculty of Health, University of Technology, 235-253 Jones St, Ultimo NSW 2007
Country 60864 0
Australia
Phone 60864 0
+61 2 9514 4813
Fax 60864 0
+61 2 9514 4835
Email 60864 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23395Study protocol   

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 naturalistic study of herbal medicine for self-reported depression and/or anxiety a protocol.2019https://dx.doi.org/10.1016/j.imr.2019.04.007
N.B. These documents automatically identified may not have been verified by the study sponsor.