Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000163000
Ethics application status
Approved
Date submitted
12/02/2010
Date registered
19/02/2010
Date last updated
5/08/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study assessing the ability of a Manuka honey preparation to treat the symptoms of cold sores when applied topically
Scientific title
A single open-labelled study to assess the safety and performance of a Leptospermum scoparium (Manuka) essential oil preparation for the topical treatment of cold sores
Secondary ID [1] 1419 0
"nil"
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cold sores 256812 0
Condition category
Condition code
Alternative and Complementary Medicine 256963 256963 0 0
Other alternative and complementary medicine
Infection 256964 256964 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cold sore cream:
Actives:
Manuka oil 100mg
Zinc Oxide 150mg
Calendula extract 1:1 156mg
Propolis extract 5:1 30mg

Excipients:
castor oil
jojoba oil
Olive oil
Carnauba wax
Candellila wax
Mixed Tocopherols
Ethanol

Cream should be applied topically to the cold sore as soon as signs of it appears and applied every 4 hours. The cream should be used until cold sore resolves which is usually any where between 4 and 10 days.
Intervention code [1] 256021 0
Treatment: Other
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 257847 0
Cold sore Duration which assessed through a participants diary.
Timepoint [1] 257847 0
baseline
First episode of acute cold sore breakout until cold sore resolves, usually between 4 to 10 days.
Primary outcome [2] 257848 0
Cold sore severity using a simple measurement rating scale (1-10) that will be used to measure cold sore severity on a daily basis
Timepoint [2] 257848 0
baseline
First episode of acute cold sore breakout from the first sign of a cold sore until the cold sore resolves, usually between 4 to 10 days.
Secondary outcome [1] 263283 0
Presence of Mild tingling/itching assess through the participants diary.
Timepoint [1] 263283 0
First day of acute cold sore breakout and daily until cold sore resolves.
Secondary outcome [2] 263284 0
Presence of hard spot at cold sore site assessed through participants diary.
Timepoint [2] 263284 0
First day of acute cold sore breakout and daily until cold sore resolves.
Secondary outcome [3] 263285 0
Presence of swelling at cold sore site assessed through participants diary.
Timepoint [3] 263285 0
First day of acute cold sore breakout and daily until cold sore resolves.
Secondary outcome [4] 263286 0
Presence of small in-tact (unbroken) blisters assessed through participants diary.
Timepoint [4] 263286 0
First day of acute cold sore breakout and daily until cold sore resolves.
Secondary outcome [5] 263287 0
Presence of broken blisters/ ulcers with crusting assessed through participants diary.
Timepoint [5] 263287 0
First day of acute cold sore breakout and daily until cold sore resolves.
Secondary outcome [6] 263288 0
Resolution of cold sore (crust has fallen off) assessed through participants diary.
Timepoint [6] 263288 0
First day of acute cold sore breakout and daily until cold sore resolves.
Secondary outcome [7] 263289 0
Presence of fever ( > 37.5 degrees celsius) assessed through participants diary. Participant will measure temperature with a thermometer and record reading.
Timepoint [7] 263289 0
First day of acute cold sore breakout and daily until cold sore resolves.
Secondary outcome [8] 263290 0
sore throat / pain when swallowing assessed through participants diary.
Timepoint [8] 263290 0
First day of acute cold sore breakout and daily until cold sore resolves.
Secondary outcome [9] 263291 0
Presence of lethargy assessed through participants diary.
Timepoint [9] 263291 0
First day of acute cold sore breakout and daily until cold sore resolves.
Secondary outcome [10] 263292 0
presence of swollen neck glands assessed through participants diary. patient will assess whether galnds in neck are sore and swollen to the touch.
Timepoint [10] 263292 0
First day of acute cold sore breakout and daily until cold sore resolves.
Secondary outcome [11] 263293 0
feeling dehydrated assessed through participants diary.
Timepoint [11] 263293 0
First day of acute cold sore breakout and daily until cold sore resolves.

Eligibility
Key inclusion criteria
Experience more than 2 cold sore episodes in the past year
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Currently pregnant or likely to become pregnant in next 6 months
2. currently breastfeeding
3. participating or have participated in another clinical trial in the last 30 days
4. currently active cancer or had cancer in last 5 years

5. Been diagnosed wiht chronic disease that requires significant pharmaceutical therapy (i.e. diabetes, cardiovascular disease [CVD], stroke)
6. Diagnosed wiht thrombosis and/or currently taking blood thinners such as warfarin or heparin
7. unstable depression and/or being treated for any other psychological condition
8. alcohol or drug-dependency problems
9. The use of a drug/natural therapy (eg Acyclovir / Lauriad) for treating cold sores in within the last 30days.

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)
Initial screening will be conducted through telephone conversation and will be asked to attend research clinic if they meet the inclusion criteria. Consent will be gained at assessment and upon medical assessment, all participants will be given the investigational product.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Non-randomised
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256519 0
Commercial sector/Industry
Name [1] 256519 0
Taurean Health Products
Country [1] 256519 0
United Kingdom
Primary sponsor type
Commercial sector/Industry
Name
Taurean Health Products
Address
Ground floor offices
The Old Grammar School
Ramsey Rd, St Ives
PE27 5 BZ
UK
Country
United Kingdom
Secondary sponsor category [1] 255830 0
None
Name [1] 255830 0
Address [1] 255830 0
Country [1] 255830 0
Other collaborator category [1] 1121 0
Other Collaborative groups
Name [1] 1121 0
Applied Science and Nutrition Research
Address [1] 1121 0
PO Box 38
New Farm
QLD 4005
Country [1] 1121 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258567 0
Australian College of Natural Therapies Ethics Committee
Ethics committee address [1] 258567 0
Ethics committee country [1] 258567 0
Australia
Date submitted for ethics approval [1] 258567 0
01/02/2008
Approval date [1] 258567 0
17/07/2008
Ethics approval number [1] 258567 0
HREC016

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

Contacts
Principal investigator
Name 30843 0
Address 30843 0
Country 30843 0
Phone 30843 0
Fax 30843 0
Email 30843 0
Contact person for public queries
Name 14090 0
Elizabeth Steels
Address 14090 0
188 James street
New Farm
QLD 4005
Country 14090 0
Australia
Phone 14090 0
+61 7 3162 0909
Fax 14090 0
+61 7 3852 6183
Email 14090 0
[email protected]
Contact person for scientific queries
Name 5018 0
Elizabeth Steels
Address 5018 0
188 James street
New Farm
QLD 4005
Country 5018 0
Australia
Phone 5018 0
+61 7 3162 0909
Fax 5018 0
+61 7 3852 6183
Email 5018 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.