None listed
Conditions
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)
Interventions
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 PH
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.
Sponsors
University of Technology Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
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).
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
Outcome results
None listed