Condition category
Infections and Infestations
Date applied
15/03/2016
Date assigned
17/03/2016
Last edited
16/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mathias Schmidt

ORCID ID

Contact details

Herbresearch Germany
Wartbergweg 15
Mattsies
86874
Germany
+49 8268 908174
schmidt@herbresearch.de

Type

Scientific

Additional contact

Mrs Marie Hladíková

ORCID ID

Contact details

Department of Medical Informatics
2nd Faculty of Medicine
Charles University of Prague
V Úvalu 84
Prague 5
CZ-15006
Czech Republic
+420 731019604
statistika.hladikova@seznam.cz

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Lotion containing propolis special extract GH 2002 0,5% vs. placebo in the treatment of Herpes zoster

Acronym

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

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.

Study design

Single-centre placebo-controlled non-randomised study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

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

Phase

Drug names

Primary outcome measures

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 trial start date

24/02/2012

Overall trial end date

14/01/2014

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant exclusion criteria

None

Recruitment start date

24/02/2012

Recruitment end date

17/12/2013

Locations

Countries of recruitment

Czech Republic

Trial participating centre

Dr. Simona Holcová, Consultancy for Dermatology
Jugoslávská 13
Brno
61300
Czech Republic

Sponsor information

Organisation

Gehrlicher Pharmazeutische Extrakte GmbH

Sponsor details

Robert-Koch-Str. 5
Eurasburg/Obb.
D-82547
Germany
+49 8170 997790
production@gehrlicher.de

Sponsor type

Industry

Website

http://www.gehrlicher.de

Funders

Funder type

Industry

Funder name

Gehrlicher Pharmazeutische Extrakte GmbH

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Publication of study results in a peer reviewed journal.

Intention to publish date

31/12/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes