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ROTEM and Dietary Supplements

Viscoelastic Point-of-Care Coagulation Monitoring and Dietary Supplements: A Randomized, Double-blind, Placebo-controlled Trial

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03125551
Enrollment
0
Registered
2017-04-24
Start date
2017-06-30
Completion date
2017-08-31
Last updated
2018-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dietary Supplements, Bleeding Tendency; Due to Coagulation Defect

Keywords

Dietary supplements, Bleeding tendency

Brief summary

Dietary Supplements can affect platelet activation and aggregation, which could result in bleeding tendencies. This study wishes to evaluate the influence that these supplements has on platelet function using Rotational thromboelastometry.

Detailed description

The WHO informs us that more than 80% of patients in Africa use traditional/herbal medicines as their primary source of health care. The Mayo Clinic stated that nearly 40% of adults reported using complementary and alternative medicine (CAM). Many of these herbal medicines as well as dietary supplements have effects on the coagulation cascade and have been identified as such using laboratory tests including aPTT, PT, INR, light transmission aggregometry and impedence aggregometry to mention but a few. This study wishes to evaluate coagulation abnormalities using viscoelastic point-of-care coagulation monitoring in this population. This test is readily available in large hospitals and academic settings and is increasingly being used in perioperative medicine. It provides information on coagulation and thrombolysis with minimal delay when compared to other laboratory-based coagulation tests. The dietary supplements which will be evaluated in this study are ginger, garlic, gingko biloba and ginseng. These four herbal supplements were identified as the most commonly used substances known to modulate the coagulation system. These herbal supplements will be investigated within their maximum daily allowance dosages. A five-armed placebo-controlled study will be undertaken and study subjects will be recruited on a volunteer basis. Subjects will be divided into five groups and each group will receive one of the four dietary supplements and the fifth group placebo, for a two week period. Rotational thromboelastometry (ROTEM) studies will be performed on blood samples obtained from each participant at baseline and at the end of the treatment period to identify coagulation abnormalities. Most of these herbal medicines have been identified to affect platelet function and this study will specifically look at platelet function determined by maximum clot firmness (MCF) in the ROTEM analysis. Viscoelastic point-of-care coagulation monitoring in patients using herbal medicines and dietary supplements will aid decision making regarding cause of perioperative haemorrhage and need for specific blood products. It will therefore assist with goal-directed management of perioperative haemorrhage. It will also aid the anaesthetist wishing to employ a regional anaesthetic technique in this patient group.

Interventions

DIETARY_SUPPLEMENTGinger

Ginger dosage at daily recommended allowance

DIETARY_SUPPLEMENTGarlic

Garlic dosage at daily recommended allowance

DIETARY_SUPPLEMENTGinkgo Biloba

Ginkgo Biloba dosage at daily recommended allowance

DIETARY_SUPPLEMENTGinseng

Ginseng dosage at daily recommended allowance

OTHERPlacebo

Daily dosage strategy

Sponsors

University of Pretoria
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Each participant will be blinded to the dietary supplement which they will be taking. The medical technologist doing the ROTEM will be blinded to the dietary supplements as well.

Intervention model description

Five- armed, placebo- controlled ( 4 intervention groups and 1 placebo group)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

1. Age 18-60 years 2. Both males and females 3. Healthy volunteers 4. Smokers and Non-smokers 5. Staff frequenting the theatre complex at Steve Biko Academic Hospital

Exclusion criteria

1. Use of any medication, excluding oral contraceptive pills, in the two week period prior to commencement of the study. Medicines excluded, include aspirin, dietary supplements, herbal teas, anticoagulants and other non-steroidal anti-inflammatory medications. . Oral contraceptive pills were omitted as an

Design outcomes

Primary

MeasureTime frameDescription
Platelet dysfunction determined by ROTEM when consuming ginger, garlic, ginkgo biloba and ginseng.2-4 weeksTo determine if viscoelastic point-of-care coagulation monitoring (ROTEM) detects abnormalities in platelet function when subjects consume ginger, garlic, ginkgo biloba and ginseng within their recommended daily allowances. ExTEM and FibTEM analysis will be performed and difference in MCF values will determine if there is platelet dysfunction or not.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026