Treatment of Herpes zoster (shingles) with a lotion containing propolis extract

ISRCTN	ISRCTN17781274
DOI	https://doi.org/10.1186/ISRCTN17781274
Secondary identifying numbers	N/A

Submission date: 15/03/2016
Registration date: 17/03/2016
Last edited: 16/03/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

Background and study aims
Herpes zoster, more commonly known as shingles, is an infection caused by the varicella-zoster virus (which also causes chicken pox). It usually affects a specific area on one side of the body, and appears in the form of a painful rash that develops into itchy blisters. Some people suffering from shingles are prescribed antiviral tablets (such as acyclovir) to take in order to speed up recovery. A previous study found that rubbing a skin lotion containing propolis onto the affected areas of the skin could help to treat shingles when used alongside antiviral therapy. Propolis is a resin-like substance from in the buds of certain trees. The aim of this study is to compare two skin creams – one that contains propolis and one that does not – in order to find out whether it is the propolis or the skin cream itself that causes an improvement in shingles patients.

Who can participate?
Adults with shingles who are able to take anti-viral therapy (acyclovir).

What does the study involve?
Participants are allocated to one of two groups in a non-random way. Those in the first group are treated with acyclovir at a dose of 200mg or 400mg per day for four weeks (depending on what dose would work best for them). These participants are also given a skin care lotion containing propolis extract to apply to the affected skin areas two to three times a day. Those in the second group are also treated with 200mg or 400mg acyclovir for four weeks. These participants also apply a skin lotion which is identical to the skin lotion used in group one except that it does not contain propolis extract. Participants in both groups are interviewed on day 3 or 4, 7, 14 and 28 of treatment in order to find out if their pain levels have been reduced since using the cream.

What are the possible benefits and risks of participating?
Participants may benefit from less pain/itching without an interference with their antiviral therapy. There are no notable risks involved with taking part in this study.

Where is the study run from?
Dr. Simona Holcová, Consultancy for Dermatology (Czech Republic)

When is the study starting and how long is it expected to run for?
February 2012 to January 2014

Who is funding the study?
Gehrlicher Pharmazeutische Extrakte GmbH (Germany)

Who is the main contact?
1. Dr Mathias Schmidt (scientific)
schmidt@herbresearch.de
2. Miss Marie Hladíková (scientific)
statistika.hladikova@seznam.cz

Contact information

Dr Mathias Schmidt
Scientific

Herbresearch Germany
Wartbergweg 15
Mattsies
86874
Germany

Phone	+49 8268 908174
Email	schmidt@herbresearch.de

Mrs Marie Hladíková
Scientific

Department of Medical Informatics
2nd Faculty of Medicine
Charles University of Prague
V Úvalu 84
Prague 5
CZ-15006
Czech Republic

Phone	+420 731019604
Email	statistika.hladikova@seznam.cz

Study information

Study design	Single-centre placebo-controlled non-randomised study
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	GP practice
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet.
Scientific title	Lotion containing propolis special extract GH 2002 0,5% vs. placebo in the treatment of Herpes zoster
Study hypothesis	The aim of this study was to find out whether propolis might provide an alleviation of typical Herpes zoster pain when applied on the lesions in the form of a lotion.
Ethics approval(s)	Under the regulations of the Czech Republic approval by an ethics committee was not required due to the nature of this study as the interventional product does not interfere with the aciclovir treatment guidelines.
Condition	Herpes zoster
Intervention	Participants are allocated to one of two groups using sequential allocation. Group 1: Participants are treated with acyclovir at a dose of 200 or 400 mg/day for four weeks. The participants in this group also self-apply a skin care lotion with propolis special extract 2-3 times daily on the affected skin areas. Group 2: Participants are treated with acyclovir at a dose of 200 or 400 mg/day for four weeks. The participants in this group are also self-apply a skin care lotion with the same composition as in Group 1, except that the lotion does not contain propolis special extract. The lotion is applied 2-3 times daily on the affected skin areas. Pain is measured using a Visual Analogue Scale (VAS) at the follow-up visits on day 3 or 4, day 7, day 14 and day 28.
Intervention type	Other
Primary outcome measure	Pain is measured using a Visual Analogue Scale (VAS) at baseline, 3-4, 7, 14 and 28 days.
Secondary outcome measures	Development of Herpes zoster lesions is measured using physical assessments by the treating physician at baseline, 3-4, 7, 14 and 28 days.
Overall study start date	24/02/2012
Overall study end date	14/01/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	60
Participant inclusion criteria	1. Aged 18 to 70 years 2. Diagnosis of Herpes zoster 3. Eligible for oral treatment with acyclovir 4. No known allergy against propolis or aciclovir
Participant exclusion criteria	None
Recruitment start date	24/02/2012
Recruitment end date	17/12/2013

Locations

Countries of recruitment

Czech Republic

Study participating centre

Dr. Simona Holcová, Consultancy for Dermatology

Jugoslávská 13
Brno
61300
Czech Republic

Sponsor information

Gehrlicher Pharmazeutische Extrakte GmbH
Industry

Robert-Koch-Str. 5
Eurasburg/Obb.
D-82547
Germany

Phone	+49 8170 997790
Email	production@gehrlicher.de
Website	http://www.gehrlicher.de
"ROR"	https://ror.org/04qx49k93

Funders

Funder type

Industry

Gehrlicher Pharmazeutische Extrakte GmbH

No information available

Results and Publications

Intention to publish date	31/12/2016
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Publication of study results in a peer reviewed journal.
IPD sharing plan