Condition category
Infections and Infestations
Date applied
27/09/2012
Date assigned
08/10/2012
Last edited
06/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
We were carrying out this study in order to measure the effect of an herbal
preparation containing a special extract of the medicinal plants chamomile, rose, lavender,
myrrh, willow bark and spiny rush on HIV infection. The aim is to
test the potential of the herbal preparation for an improvement in virus load and immune cells
in patients diagnosed as HIV positive but not yet eligible for treatment with antiviral
medications. This situation, where the patient cannot receive medication because the risk of
adverse effects and formation of resistance, can be considered a therapeutic gap, leaving the
patient on his/her own with a dreadful perspective. A well-tolerated herbal preparation contributing
to controlling the virus load and the immune status in the early stages of an HIV infection is
expected to increase the quality of life of the patients, and delay the aggravation of the
response of the immune system even to minor threats.

Who can participate?
Adults up to the age of 50 diagnosed with HIV who have a virus load and CD4-cell count below
the threshold for the prescription of an antiviral medical treatment.

What does the study involve?
Within the study, only routine examination results are documented, as they would have been
obtained from regular medical supervision. In addition, the typical laboratory blood
examinations on liver and kidney function and blood lipids are documented as an additional
safety aspect. The study is designed for an observation period of 3 months.

What are the possible benefits and risks of participating?
A delay of the requirement of antiviral treatment is a major clinical achievement in HIV
treatment: it increases the quality of life of HIV patients, and postpones the risk of resistance
formation against antiviral medications, as well as the risk of adverse effects. In previous examinations and experience with exposure to the herbal preparation, no adverse reactions have been observed. Participating patients are screened for potential adverse events.

Where is the study run from?
The study is run from clinical HIV healthcare centres.

When is the study starting and how long is it expected to run for?
The study started in 2012 and is expected to finish in the same year.

Who is funding the study?
Funding has been provided by GHS AG in Liechtenstein, a company financially supporting the
development of the herbal preparation by its inventor, Mrs Monica Volkmar.

Who is the main contact?
Dr Mathias Schmidt
schmidt@herbresearch.de

Trial website

Contact information

Type

Scientific

Primary contact

Dr Martin Imhof

ORCID ID

Contact details

Dorotheergasse 7
Wien
1010
Austria
+43 1 5130607
ordination@imhof.at

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

GHS-0312/kl

Study information

Scientific title

Documentation of the clinical effect and safety of V.II-BE on immunological parameters of HIV-infected patients: an open prospective trial

Acronym

Study hypothesis

The intake of the herbal preparation V.II-BE contributes to lowering the virus load and increases the number of circulating CD4 cells in patients infected with human immunodeficiency virus (HIV), but still not sufficiently diseased to be eligible for treatment with antiviral medication.

Ethics approval

Ethics Committee of the study centre in Cluj, Romania, 28/05/2012

Study design

Open prospective study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

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

Condition

HIV at a stage where antiviral treatment is not yet recommended according to medical guidelines

Intervention

All patients receive the V.II-BE solution (special extract of the medicinal plants chamomile, rose, lavender, myrrh, willow bark and spiny rush). The product contains 90% ethanol. The recommended dose is 60 drops twice daily with a little water for 3 months.

Intervention type

Drug

Phase

Not Applicable

Drug names

V.II-BE (herbal preparation)

Primary outcome measures

Virus load and CD4 cell count

Secondary outcome measures

Safety laboratory values

Overall trial start date

01/06/2012

Overall trial end date

31/12/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients up to the age of 50 diagnosed with an HIV infection
2. Virus load below 50,000 copies/ml of blood
3. CD4 cell count above 350 cells/µl of blood
4. Stable virus load for the past 6 months

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30-40

Participant exclusion criteria

Patients cannot be included if:
1. They receive antiviral medication
2. They are treated with antibiotics
3. They undergo chemotherapy for cancer treatment
4. They have a background of abusing alcohol or illicit drugs
5. They have a co-infection with hepatitis
6. They are, in the case of women, pregnant or lactating

Recruitment start date

01/06/2012

Recruitment end date

31/12/2012

Locations

Countries of recruitment

Romania

Trial participating centre

Dorotheergasse 7
Wien
1010
Austria

Sponsor information

Organisation

GHS AG (Liechtenstein)

Sponsor details

Letzanaweg 23
POB 20
Triesen
FL-9495
Liechtenstein

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

GHS AG (Liechtenstein)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes