Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000220965
Ethics application status
Not yet submitted
Date submitted
28/02/2011
Date registered
28/02/2011
Date last updated
11/04/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effectiveness of Multi-Berry Juice in the Treatment of Eczema and Acne Using Pre Post Methodology
Scientific title
Does drinking a multi-berry, anti-oxidant juice improve the symptoms of patients with eczema and acne comparing pre and post treatment?
Secondary ID [1] 259690 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
eczema 261263 0
acne 261265 0
Condition category
Condition code
Skin 259416 259416 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will use a pre-post design to explore the possibility of an effect of berry juice on the severity of acne/eczema. The juice will be a Canadian-produced juice containing red raspberry, blueberry, blackberry, boysenberry, cranberry, blackcurrant, elderberry, fucoidan, bladderwrack, ulva, fructose, and potassium sorbate. Enrolled patients will be given a 2 week washout period prior to beginning their course of berry juice in order to ensure previous acne/eczema medications are absent from the body. A baseline measure will be taken. Patients will be then be provided with a 6 week course of berry juice. They will drink 3oz of juice daily. At the end of the 6 weeks, severity of acne/eczema will be measured.
Intervention code [1] 258118 0
Treatment: Other
Comparator / control treatment
symptoms are compared pre and post treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 262224 0
acne - 50% reduction in the number of lesions on the face and neck

eczema - 50% reduction in "SCORAD" score
Timepoint [1] 262224 0
After 6 weeks of juice treatment
Secondary outcome [1] 273351 0
nil
Timepoint [1] 273351 0
nil

Eligibility
Key inclusion criteria
Adults (>= 18 years of age) with known diagnoses of eczema or acne. Patient may be new diagnoses not taking treatment; patients who are willing to go off standard treatment; or patients who have tried standard treatment with no success.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Undiagnosed skin disorders – subjects need to have been diagnosed by a physician Patients for whom it would be prohibitively burdensome to not be treated with standard acne/eczema treatment. Known allergies to the contents of the juice – red raspberry, blueberry, blackberry, boysenberry, cranberry, blackcurrant, elderberry, fucoidan, bladderwrack, ulva, fructose, potassium sorbate Patients taking antibiotics, diuretics, blood thinners and theophylline – there are no clinical trials but just theoretical effects that the juice may have on these medications Because of the theoretical effects that the juice has on blood and kidneys, patients who have the following diagnoses are also excluded: Pregnancy, kidney failure, blood disorders, and cancer. Patients taking Diane 35 for acne

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
96
Accrual to date
Final
Recruitment outside Australia
Country [1] 3239 0
Canada
State/province [1] 3239 0

Funding & Sponsors
Funding source category [1] 258577 0
Commercial sector/Industry
Name [1] 258577 0
our World Network, Inc
Country [1] 258577 0
Canada
Primary sponsor type
Individual
Name
Lizette Elumir
Address
141-755 Lake Bonavista Dr. SE
Calgary, AB T2J0N3
Country
Canada
Secondary sponsor category [1] 263716 0
None
Name [1] 263716 0
nil
Address [1] 263716 0
nil
Country [1] 263716 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 260562 0
Ethics committee address [1] 260562 0
Ethics committee country [1] 260562 0
Date submitted for ethics approval [1] 260562 0
01/03/2011
Approval date [1] 260562 0
Ethics approval number [1] 260562 0

Summary
Brief summary
A significant body of research has been dedicated to addressing the antioxidant activity associated with consuming berries and other foods. Studies have purported the anti-inflammatory and anti-microbial activity of these berries and foods. Multi-berry juices have emerged trying to combine concentrated amounts of various berries in attempt to maximize the antioxidant properties.

Traditionally, berries and multi-berry drinks have been used as home remedies to improve such conditions as skin rashes and bowel disorders. However, there are only a small number of studies that address the clinical benefits of multi-berry drinks and even a smaller number of studies specifically addressing skin and bowel disorders.

More and more patients are trying these antioxidant beverages. How do primary care physicians make sense of the research so that they can provide recommendations to these patients?
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32278 0
Address 32278 0
Country 32278 0
Phone 32278 0
Fax 32278 0
Email 32278 0
Contact person for public queries
Name 15525 0
Lizette Elumir
Address 15525 0
141-755 Lake Bonavista Dr. SE
Calgary, AB T2J0N3
Country 15525 0
Canada
Phone 15525 0
+1-403-852-4946
Fax 15525 0
Email 15525 0
[email protected]
Contact person for scientific queries
Name 6453 0
Lizette Elumir
Address 6453 0
141-755 Lake Bonavista Dr. SE
Calgary, AB T2J0N3
Country 6453 0
Canada
Phone 6453 0
+1-403-852-4946
Fax 6453 0
Email 6453 0
[email protected]

No information has been provided regarding IPD availability


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
Dimensions AIImmunopotentiating Activity of Fucoidans and Relevance to Cancer Immunotherapy2023https://doi.org/10.3390/md21020128
N.B. These documents automatically identified may not have been verified by the study sponsor.