A pilot trial of topical St John’s Wort in the treatment of post-herpetic neuralgia

Phase 2

Recruiting

• Conditions: post-herpetic neuralgia; Alternative and Complementary Medicine - Herbal remedies; Neurological - Other neurological disorders

• Registration Number: ACTRN12615001002572
• Lead Sponsor: niversity of Technology Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-25
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The effectiveness of a herbal treatment on clinical quality of life measures of post-herpetic neuralgia as measured by SF-36 [Week 1 - end of initial placebo<br>Weeks 5, 9 - indicate end of each 4 week intervention period (active/control)];The effectiveness of a herbal treatment on clinical pain measures of post-herpetic neuralgia as measured by Visual Analogue (Pain) Scale (VAS); [Week 1 - end of initial placebo<br>Weeks 5, 9 - indicate end of each 4 week intervention period (active/control)]

Secondary Outcome Measures

Name	Time	Method
Tolerability of a herbal treatment in PHN (adverse events)<br><br>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). <br><br>Assessed via self-reported outcomes by patients in diary[Week 1 - end of initial placebo<br>Weeks 5, 9 - indicate end of each 4 week intervention period (active/control)]