Effects of naturopathic medicine on platelet function and coagulation measurements

ISRCTN ISRCTN78027929
DOI https://doi.org/10.1186/ISRCTN78027929
Secondary identifying numbers 1a
Submission date
11/05/2015
Registration date
19/05/2015
Last edited
14/06/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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 primary 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). A secondary aim was to evaluate the effect of in vitro added ASA prior to Multiplate analyses in blood from healthy volunteers who had ingested Omega-3 in normal dose.

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

Contact information

Dr Thomas Kander
Scientific

Skåne University Hospital
Lund
22185
Sweden

Study information

Study designSingle-centre experimental study
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Other
Study typeOther
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleEffects of naturopathic medicine on Multiplate and ROTEM: a prospective experimental pilot study on healthy volunteers
Study objectivesCurrent study hypothesis as of 31/01/2020:
The aim of this pilot study was to examine the effects of the 7 different naturopathic drugs listed
by the Swedish Medical Products Agency, utilizing the multiple electrode platelet aggregometer
(Multiplate) and the viscoelastic rotational thromboelastometer (ROTEM) in healthy humans
after 7 consecutive days of peroral intake. A secondary aim was to evaluate the effect of in vitro
added Asprin (ASA) to blood samples prior to Multiplate analyses

Previous 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(s)Regional Ethical Review Board, Lund, Sweden, ref: 2010/482.
Health condition(s) or problem(s) studiedStudy on healthy volunteers
InterventionThirty 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Not provided at time of registration
Primary outcome measurePlatelet function measured with Multiplate
Secondary outcome measuresCoagulation evaluation measured with ROTEM

Primary and secondary outcomes were measured continuously during the recruitment, i.e. 1 November -- 30 November, 2014
Overall study start date01/08/2014
Completion date15/12/2019

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
SexBoth
Target number of participants35
Key inclusion criteriaAdult healthy volunteers
Key exclusion criteria1. 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
Date of first enrolment01/11/2014
Date of final enrolment12/12/2019

Locations

Countries of recruitment

  • Sweden

Study participating centre

Skåne University hospital
Getingevägen
Lund
22185
Sweden

Sponsor information

Skåne University Hospital
University/education

Department of Intensive- and Peri-operative Care
Getingevägen
Lund
22185
Sweden

ROR logo "ROR" https://ror.org/02z31g829

Funders

Funder type

Not defined

N/A

No information available

Results and Publications

Intention to publish date01/07/2020
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planWe are planning to publish the results of this study in a scientific journal during 2015.
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 17/02/2016 Yes No
Results article 02/07/2020 14/06/2023 Yes No

Editorial Notes

14/06/2023: Publication reference added.
31/01/2020: The following changes have been made:
1. The study hypothesis has been updated.
2. The recruitment end date has been changed from 30/11/2014 to 12/12/2019.
3. The overall trial end date has been changed from 15/04/2015 to 15/12/2019.
4. The intention to publish date has been changed from 01/07/2015 to 01/07/2020.
5. The plain English summary has been updated to reflect the changes above.
19/09/2016: Publication reference added.