ROTEM and Dietary Supplements

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-30

Study Completion Date

2017-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Dietary Supplements Bleeding Tendency; Due to Coagulation Defect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

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Ginger

Ginger ( Zingiber officinale) 4 grams po dly for 14 days

Group Type ACTIVE_COMPARATOR

Ginger

Intervention Type DIETARY_SUPPLEMENT

Ginger dosage at daily recommended allowance

Garlic

Garlic (Allium sativum) 4-12 mg alliin po dly for 14 days

Group Type ACTIVE_COMPARATOR

Garlic

Intervention Type DIETARY_SUPPLEMENT

Garlic dosage at daily recommended allowance

Ginkgo Biloba

Ginkgo Biloba 40mg po tds for 14 days

Group Type ACTIVE_COMPARATOR

Ginkgo Biloba

Intervention Type DIETARY_SUPPLEMENT

Ginkgo Biloba dosage at daily recommended allowance

Ginseng

Ginseng 400mg po dly for 14 days

Group Type ACTIVE_COMPARATOR

Ginseng

Intervention Type DIETARY_SUPPLEMENT

Ginseng dosage at daily recommended allowance

Placebo

Placebo po dly for 14 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Daily dosage strategy

Interventions

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Ginger

Ginger dosage at daily recommended allowance

Intervention Type DIETARY_SUPPLEMENT

Garlic

Garlic dosage at daily recommended allowance

Intervention Type DIETARY_SUPPLEMENT

Ginkgo Biloba

Ginkgo Biloba dosage at daily recommended allowance

Intervention Type DIETARY_SUPPLEMENT

Ginseng

Ginseng dosage at daily recommended allowance

Intervention Type DIETARY_SUPPLEMENT

Placebo

Daily dosage strategy

Intervention Type OTHER

Eligibility Criteria

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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

2. History of any chronic medical or psychiatric illness.
3. Current excessive alcohol intake - more than 14 units a week in woman and more than 21 units a week in men.
4. Pregnant or lactating mothers.
5. Possible planned surgery during the study period

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes