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Trial registered on ANZCTR


Registration number
ACTRN12615001002572
Ethics application status
Approved
Date submitted
10/07/2015
Date registered
25/09/2015
Date last updated
13/12/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot trial of topical St John’s Wort in the treatment of post-herpetic neuralgia
Scientific title
A pilot randomised controlled trial of topical St John’s Wort in the treatment of post-herpetic neuralgia
Secondary ID [1] 287071 0
Nil
Universal Trial Number (UTN)
U1111-1172-0635
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
post-herpetic neuralgia 295571 0
Condition category
Condition code
Alternative and Complementary Medicine 295840 295840 0 0
Herbal remedies
Neurological 295841 295841 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: A topical olive oil extraction of St John's Wort (Hypericum perforatum).

Dose: 1mL of 0.23mg/mL fresh plant tincture olive oil extraction, administered three times daily.

Duration of use: 4 weeks

Design: 1 week with all participants on placebo, then 4 weeks on intervention/control, then 4 weeks on crossover intervention/control. No washout period between 4 week intervention/control periods.

Mode of administration: topical application will be applied to the area affected by PHN

Strategies used to monitor adherence: empty lotion bottle return and bottle measurement open completion.
Intervention code [1] 292303 0
Treatment: Drugs
Comparator / control treatment
Placebo - olive oil with red food colouring
Control group
Placebo

Outcomes
Primary outcome [1] 295528 0
The effectiveness of a herbal treatment on clinical pain measures of post-herpetic neuralgia as measured by Visual Analogue (Pain) Scale (VAS);
Timepoint [1] 295528 0
Week 1 - end of initial placebo
Weeks 5, 9 - indicate end of each 4 week intervention period (active/control)
Primary outcome [2] 295529 0
The effectiveness of a herbal treatment on clinical quality of life measures of post-herpetic neuralgia as measured by SF-36
Timepoint [2] 295529 0
Week 1 - end of initial placebo
Weeks 5, 9 - indicate end of each 4 week intervention period (active/control)
Secondary outcome [1] 315784 0
Tolerability of a herbal treatment in PHN (adverse events)

Examples of unlikely, but potential (known) adverse reactions include skin photosensitivity and irritation. Some adverse events and drug interaction are known to occur with internal use (though not topical use), and patients have been issued with a safety sheet asking them to report to study coordinator should these symtpoms (e.g. weight loss, nausea, headache).

Assessed via self-reported outcomes by patients in diary
Timepoint [1] 315784 0
Week 1 - end of initial placebo
Weeks 5, 9 - indicate end of each 4 week intervention period (active/control)

Eligibility
Key inclusion criteria
- Any person male or female aged 18-65 presenting with a confirmed diagnosis of herpetic neuralgia.

- Willingness to give written informed consent and willingness to participate to and comply with the study (and who do not meet exclusion criteria – see below).
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Other infectious skin diseases

- Diagnosed hepato-bilary disease/inflammation

- Current or < 6 month substance abuse disorder including alcohol

- Current or < 12 month use of St. John’s wort

- Current or < 1 month of therapeutic agents with narrow therapeutic windows (e.g. warfarin, anti-retroviral mediciations)

- Previous reaction to St. John’s wort

- Medications that maybe pharmacokinetically altered via St. John’s wort including: amitriptyline, anti-coagulants e.g. phenprocoumon, warfarin, anti-fugals e.g. voriconazole, anti-histamines e.g. fexofenadine, benzodiazepines e.g. alprazolam, Chemotherapeutics e.g. irinotecan, digoxin, HIV medication (anti-retrovirals), Immunosuppressants e.g. cyclosporine, methadone, OCP, statins e.g. simvastatin, warfarin (Henderson 2002; Izzo 2004). However this interactions are based on case studies and theoretical interactions and are regarded to be induced by hyperforin (a constituent of St. John’s wort); low or non-standardised hyperforin preparations are regarded to not induce drug interactions as little induction of P-glycoprotein and CYP P450 enzymes occurs (Madabushi et al. 2006).

- Non-English speakers.

- More than 6 months since the onset of acute herpetic rash

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)
The study will be blinded by using active and controls with reference numbers allocated by the manufacturer. These will only be revealed at the end of the trial, when the reference number is matched to participants reference number.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjects will be randomised in sequence according to the reference numbers provided, using computerised sequence generation (simple randomisation using a randomisation table created by computer software). These will only be revealed at the end of the trial, when the reference number is matched to participants reference number.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/11/2015
Actual
1/11/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 291632 0
University
Name [1] 291632 0
University of Technology Sydney
Country [1] 291632 0
Australia
Primary sponsor type
University
Name
University of Technology Sydney
Address
Faculty of Health, 235-253 Jones St, Ultimo, NSW 2007
Country
Australia
Secondary sponsor category [1] 290303 0
None
Name [1] 290303 0
Address [1] 290303 0
Country [1] 290303 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293162 0
University of Technology Sydney
Ethics committee address [1] 293162 0
Faculty of Health, 235-253 Jones St, Ultimo NSW 2007
Ethics committee country [1] 293162 0
Australia
Date submitted for ethics approval [1] 293162 0
Approval date [1] 293162 0
09/04/2015
Ethics approval number [1] 293162 0
2014000104

Summary
Brief summary
Description: Post-herpetic neuralgia (PHN) is a condition in which there are few effective therapies, and most of those which do show some efficacy have an unfavourable side effect
profile. This study will explore whether a widely used clinical complementary therapy may have a role in the treatment of PHN. In addition to confirming whether SJW is effective in PHN, this research will help to build an evidence base for complementary therapies. Despite being widely
used, most complementary therapies remain unstudied. This research will help to uncover the effectiveness, or lack thereof, of SJW in PHN.

Objectives: Primary – The effectiveness of a herbal treatment on clinical measures of post-herpetic neuralgia.
Secondary – Tolerability of a herbal medicine treatment in the treatment of post-herpetic neuralgia

Study design: Double-blind randomised cross-over clinical trial

Planned sample size: 40-60 (pilot)

Selection criteria: Persons with a confirmed diagnosis of herpetic neuralgia.

Study procedures: The design of the study is a randomised, placebo controlled pilot trial recruiting 40-45 adults (18-65) with post-herpetic neuralgia (PHN). The clinical trial will be conducted over 9 weeks in 3 phases. All the participants will receive placebo application for the 1st phase (washout-placebo phase - 1 week), then group 1 (determined via randomisation) will continue to take placebo for 4 weeks, while group 2 will receive the active St. John’s Wort topical application (SJW). The next phase involves both groups 1 and 2 crossing over for 4 weeks. The topical application will be applied to the area affected by PHN twice daily, this will differ depending on the severity and extent of PHN in individual patients.

Statistical considerations: As a pilot study of a treatment in common clinical use, but with no data to calculate effect size, a pilot trial of 40-60 persons will be conducted.

Study duration: 4 weeks (participant). Recruitment will last for 1 year (12 months)
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58718 0
Dr Jon Wardle
Address 58718 0
Faculty of Health, University of Technology Sydney, 235-253 Jones St, Ultimo, NSW 2007
Country 58718 0
Australia
Phone 58718 0
+61 2 9514 4813
Fax 58718 0
Email 58718 0
[email protected]
Contact person for public queries
Name 58719 0
Dr Jon Wardle
Address 58719 0
Faculty of Health, University of Technology Sydney, 235-253 Jones St, Ultimo, NSW 2007
Country 58719 0
Australia
Phone 58719 0
+61 2 9514 4813
Fax 58719 0
Email 58719 0
[email protected]
Contact person for scientific queries
Name 58720 0
Dr Jon Wardle
Address 58720 0
Faculty of Health, University of Technology Sydney, 235-253 Jones St, Ultimo, NSW 2007
Country 58720 0
Australia
Phone 58720 0
+61 2 9514 4813
Fax 58720 0
Email 58720 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

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