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
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