Plain English Summary
Background and study aims
Many patients undergoing surgery use naturopathic drugs (a form of alternative medicine). Several of these have been reported to increase bleeding in patients . The Swedish Medical Products Agency recommends that patients stop taking the naturopathic medicines echinacea, fish oil, ginkgo biloba, ginseng, St. John’s wort, valeriana and garlic two weeks before they have surgery. The aim of this pilot study is to examine the effects of these naturopathic drugs on the ability of the blood to clot using two different methods; the multiple electrode platelet aggregometer (Multiplate) and the viscoelastic rotational thromboelastometer (ROTEM).
Who can participate?
Adult healthy volunteers
What does the study involve?
Participants all take a standard recommended dose of one of the neuropathic drugs to be tested for seven days. Blood samples are taken throughout the study period to assess platelet function and coagulation (both important for blood clotting),
What are the possible benefits and risks of participating?
There are no benefits, except for free naturopathic drugs, of participating in this study. The naturopathic drugs in this study can be bought over the counter without prescription and our assessment is that the drugs studied are harmless.
Where is the study run from?
Skåne University Hospital, Lund (Sweden)
When is the study starting and how long is it expected to run for?
August 2014 to April 2015
Who is funding the study?
Lund University
Who is the main contact?
Dr Thomas Kander
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1a
Study information
Scientific title
Effects of naturopathic medicine on Multiplate and ROTEM: a prospective experimental pilot study on healthy volunteers
Acronym
Study hypothesis
The aim of this pilot study was to examine the effects of the 7 different naturopathic drugs listed by the Swedish Medical Products Agency, utilising the multiple electrode platelet aggregometer (Multiplate) and the viscoelastic rotational thromboelastometer (ROTEM) in healthy humans after 7 consecutive days of peroral intake.
Ethics approval
Regional Ethical Review Board, Lund, Sweden, ref: 2010/482.
Study design
Single-centre experimental study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Other
Trial type
Other
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Study on healthy volunteers
Intervention
Thirty five healthy volunteers gave signed consent to ingest one of the listed naturopathic drugs for 7 days. Each naturopathic drug was taken in a recommended standard dose by 5 volunteers. ROTEM clot initiation (CT), clot formation (CFT), α-angle (AA) and clot structure (MCF) were analysed with tissue factor activated (EXTEM) and native (NATEM) assays. The Multiplate platelet aggregation area under curve (AUC) was measured with adenosine diphosphate (ADP), collagen (COL) and arachidonic acid (ASPI) assays.
Intervention type
Drug
Phase
Not Applicable
Drug names
Primary outcome measures
Platelet function measured with Multiplate
Secondary outcome measures
Coagulation evaluation measured with ROTEM
Primary and secondary outcomes were measured continuously during the recruitment, i.e. 1 November -- 30 November, 2014
Overall trial start date
01/08/2014
Overall trial end date
15/04/2015
Reason abandoned
Eligibility
Participant inclusion criteria
Adult healthy volunteers
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
35
Participant exclusion criteria
1. Smoking
2. Intake of any kind of anticoagulant or antithrombotic medicine including recent intake of aspirin and non-steroid anti-inflammatory drugs
3. Pregnancy or planned surgery
Recruitment start date
01/11/2014
Recruitment end date
30/11/2014
Locations
Countries of recruitment
Sweden
Trial participating centre
Skåne University hospital
Getingevägen
Lund
22185
Sweden
Funders
Funder type
Not defined
Funder name
N/A
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
We are planning to publish the results of this study in a scientific journal during 2015.
Intention to publish date
01/07/2015
Participant level data
Available on request
Results - basic reporting
Publication summary
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26887420