Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000638437p
Ethics application status
Submitted, not yet approved
Date submitted
17/03/2016
Date registered
17/05/2016
Date last updated
1/06/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of Shuzi Technology on Inflammation
Scientific title
Effects of Shuzi Technology on Inflammation in adults diagnosed with mild to moderate inflammatory condtitions
Secondary ID [1] 288567 0
Nil
Universal Trial Number (UTN)
U1111-1179-8237
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammatory Conditions 297692 0
Condition category
Condition code
Inflammatory and Immune System 297872 297872 0 0
Rheumatoid arthritis
Inflammatory and Immune System 297873 297873 0 0
Autoimmune diseases
Inflammatory and Immune System 297874 297874 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will attend the clinic for an initial consultation where a Patient Info Sheet, Consent form and SF36 Health Questionnaire will be completed and signed. The CO-Investigator is a qualified lymphatic therapist who has worked with a number of inflammatory conditions, will assess and review all documentation to ensure the inclusion criteria are met. It is proposed that the participants will provide documentation from their doctor to confirm their inflammatory condition. Participants will receive blood test paperwork and a shuzi bracelet. The Shuzi sports bracelet is a nylon bracelet embedded with a 2mm x 0.5mm metal disk composed of gold, nickel, zinc, and copper. Prior to embedding the metal disk into the bracelet, the disk is exposed to audio frequencies which were determined over a year of research and experiments to provide a proprietary range that is between 20Hz and 20kHz for 60 minutes, using a computer program. The volume of the audio is 85dB. Each participant will present at PathLab for blood testing. Blood will be analysed for CBC, CRP and DHEA with results being sent directly to the Clinic after analysis at the PathLab. On completion of blood testing, participants will put on the Shuzi bracelet and will wear it continuously throughout the six weeks including sleeping and showering. A diary will be issued to the Candidates to fill out each day. This will record if they have worn the bracelet or removed for any circumstances. Subjects will wear the bracelet for 6 weeks and then return to the clinic for a follow-up consultation and completion of another SF36 questionnaire. They will be issued with another blood test form and return to PathLab for repeat blood work, once completed they will return the Shuzi bracelet to the Clinic.
Intervention code [1] 293952 0
Treatment: Devices
Comparator / control treatment
All participants wear a bracelet. 1/2 of the group will wear a nylon bracelet with the metal disk impeded in the bracelet and 1/2 will wear a nylon bracelet without a metal disk..
Control group
Placebo

Outcomes
Primary outcome [1] 297406 0
C-Reactive Protein. Standard serum assay.
Timepoint [1] 297406 0
Timeline 1: Baseline Timeline 2: 6 Weeks.
Secondary outcome [1] 320973 0
Complete Blood Count. Standard assay
Timepoint [1] 320973 0
Timeline One: Baseline, Timeline Two: 6 weeks
Secondary outcome [2] 322585 0
Dehydroepiandrosterone. Standard serum assay
Timepoint [2] 322585 0
Timeline One: Baseline, Timeline Two: 6 weeks
Secondary outcome [3] 322586 0
SF36 Questionnaire
Timepoint [3] 322586 0
Timeline One: Baseline, Timeline Two: 6 weeks

Eligibility
Key inclusion criteria
Diagnosed with inflammatory conditions including Rheumatoid Arthritis, Osteoarthrities and bursitis, formally diagnosed by a GP or specialist.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant or maybe pregnant
Currently undertaking immune suppressing drugs or anti-inflammatory drugs
Active severe inflammatory condition and/or active severe viral condition e.g flu

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)
Standard randomisation software with sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Standard randomisation software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is an independent pilot trial funded by the manufacturer. Therefore the sample size is based on a pure data collection at this stage and a power calculation has not been performed.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Protocol was not approved by the ethics committee due to variables of blood results that would occur between inflammatory and non-inflammatory conditions.
Date of first participant enrolment
Anticipated
6/06/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 7634 0
New Zealand
State/province [1] 7634 0

Funding & Sponsors
Funding source category [1] 293018 0
Commercial sector/Industry
Name [1] 293018 0
Shuzi New Zealand Ltd
Country [1] 293018 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
New Zealand Centre of Integrated Health
Address
Suite 6, Promed House, 10th Avenue, Tauranga 3110
Country
New Zealand
Secondary sponsor category [1] 291940 0
Individual
Name [1] 291940 0
Dr Anna Rolleston
Address [1] 291940 0
Cardiac Clinic
103 Third Ave
Tauranga 3110
Country [1] 291940 0
New Zealand

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 294528 0
Health and Disability Ethics Committee
Ethics committee address [1] 294528 0
Ministry of Health
Ethics Department
Freyberg Building
Reception – Ground Floor
20 Aitken Street
Wellington 6011
Ethics committee country [1] 294528 0
New Zealand
Date submitted for ethics approval [1] 294528 0
27/05/2016
Approval date [1] 294528 0
Ethics approval number [1] 294528 0

Summary
Brief summary
The Shuzi bracelet has been available for a number of years on the market and reported changes to date are reduced pain, a sense of calmness and reduction of arthritic conditions. In order for this technology to be recognised as a product that can provide anti-inflammatory support, a high quality research pilot trial showing changes to inflammatory markers will allow the opportunity for further research to be undertaken to acknowledge that this product can assist condition based issues. Fourty participants will be recruited from the Tauranga area. To be eligible for enrollment individuals will be diagnosed with mild to moderate inflammatory condition. At the initial consultation the candidate will fill out and sign a Patient Info Sheet, Consent form and SF36. All documentation will be reviewed to ensure inclusion criteria is met. Participants will undertake blood testing of Complete Blood Count (CBC), C-Reactive Protein (CRP) and dehydroepiandrosterone(DHEA). After blood tests have been taken a shuzi bracelet will be issued. This study does have a control group of 20 candidates and therefore only 20 candidates will receive a bracelet with the technology built in to the bracelet and the remaining 20 candidates will have a bracelet with no technology. Subjects will wear the bracelet for 6 weeks and then return to the clinic for a followup consultation, to complete another SF36 questionnaire and be reissued with a blood test form to repeat blood work. The bracelet will then be returned to the clinic upon completion of the blood work.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63642 0
Dr Anna Rolleston
Address 63642 0
Cardiac Clinic
103 Third Ave
Tauranga 3110
Country 63642 0
New Zealand
Phone 63642 0
+6475786624
Fax 63642 0
Email 63642 0
[email protected]
Contact person for public queries
Name 63643 0
Ms Desiree De Spong
Address 63643 0
New Zealand Centre of Integrated Health
PO Box 15066
Tauranga 3144
or Suite 6, Promed House, 71 Tenth Ave, Tauranga 3110
Country 63643 0
New Zealand
Phone 63643 0
+64275443424
Fax 63643 0
Email 63643 0
[email protected]
Contact person for scientific queries
Name 63644 0
Dr Anna Rolleston
Address 63644 0
Cardiac Clinic
103 Third Ave
Tauranga 3110
Country 63644 0
New Zealand
Phone 63644 0
+6475786624
Fax 63644 0
Email 63644 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
No additional documents have been identified.