Effects of naturopathic medicine on platelet function and coagulation measurements
| ISRCTN | ISRCTN78027929 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78027929 |
| Protocol serial number | 1a |
| Sponsor | Skåne University Hospital |
| Funder | N/A |
- 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
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
Scientific
Skåne University Hospital
Lund
22185
Sweden
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre experimental study |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | Effects of naturopathic medicine on Multiplate and ROTEM: a prospective experimental pilot study on healthy volunteers |
| Study objectives | Current 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) studied | 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 / device / biological / vaccine name(s) | Not provided at time of registration |
| Primary outcome measure(s) |
Platelet function measured with Multiplate |
| Key secondary outcome measure(s) |
Coagulation evaluation measured with ROTEM |
| Completion date | 15/12/2019 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 35 |
| Key inclusion criteria | Adult healthy volunteers |
| Key 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 |
| Date of first enrolment | 01/11/2014 |
| Date of final enrolment | 12/12/2019 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Lund
22185
Sweden
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
