Condition category
Not Applicable
Date applied
11/05/2015
Date assigned
19/05/2015
Last edited
19/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Thomas Kander

ORCID ID

Contact details

Skåne University Hospital
Lund
22185
Sweden

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

Sponsor information

Organisation

Skåne University Hospital

Sponsor details

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

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes

19/09/2016: Publication reference added.